Cisplatin, Carboplatin and Etoposide or Temozolomide and Capecitabine in Treating Patients With Neuroendocrine Carcinoma of the Gastrointestinal Tract or Pancreas That Is Metastatic or Cannot Be Removed by Surgery

January 8, 2024 updated by: ECOG-ACRIN Cancer Research Group

Randomized Phase II Study of Cisplatin and Etoposide Versus Temozolomide and Capecitabine in Patients With Advanced G3 Non-small Cell Gastroenteropancreatic Neuroendocrine Carcinomas

This randomized phase II trial studies how well temozolomide and capecitabine work compared to standard treatment with cisplatin or carboplatin and etoposide in treating patients with neuroendocrine carcinoma of the gastrointestinal tract or pancreas that has spread to other parts of the body (metastatic) or cannot be removed by surgery. Drugs used in chemotherapy, such as temozolomide, capecitabine, cisplatin, carboplatin and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Certain types of neuroendocrine carcinomas may respond better to treatments other than the current standard treatment of cisplatin and etoposide. It is not yet known whether temozolomide and capecitabine may work better than cisplatin or carboplatin and etoposide in treating patients with this type of neuroendocrine carcinoma, called non-small cell neuroendocrine carcinoma.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVES:

I. To assess the progression free survival (PFS) of platinum (cisplatin or carboplatin) and etoposide versus the PFS of temozolomide and capecitabine in patients with advanced G3 non-small cell gastroenteropancreatic neuroendocrine carcinomas.

SECONDARY OBJECTIVES:

I. To assess the response rate (RR) of platinum (cisplatin or carboplatin) and etoposide versus the RR of temozolomide and capecitabine in patients with advanced G3 non-small cell gastroenteropancreatic neuroendocrine carcinomas.

II. To assess the overall survival (OS) of platinum (cisplatin or carboplatin) and etoposide versus the OS of temozolomide and capecitabine in patients with advanced G3 non-small cell gastroenteropancreatic neuroendocrine carcinomas.

III. To evaluate the toxicities associated with the combination of temozolomide and capecitabine and the combination of platinum (cisplatin or carboplatin) and etoposide, respectively, in patients with advanced G3 non-small cell gastroenteropancreatic neuroendocrine carcinomas.

TERTIARY OBJECTIVES:

I. To assess the impact of each treatment regimen on PFS, RR and OS based on marker of proliferation Ki-67 index in patients with advanced G3 non-small cell gastroenteropancreatic neuroendocrine carcinomas. (Laboratory) II. To assess the prognostic significance of well differentiated versus poorly differentiated non-small cell gastroenteropancreatic neuroendocrine tumors in relationship to survival and response to treatment. (Laboratory) III. To assess the agreement in Ki-67 status between that reported by institutional pathologist and that reported by central pathology review. (Laboratory)

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM A: Patients receive capecitabine orally (PO) twice daily (BID) on days 1-14 and temozolomide PO once daily (QD) on days 10-14. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

ARM B: Patients receive cisplatin intravenously (IV) on days 1-3 or carboplatin IV on day 1. Patients also receive etoposide IV on days 1-3. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.

Study Type

Interventional

Enrollment (Actual)

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Arizona
  - Kingman, Arizona, United States, 86401
    - Kingman Regional Medical Center
  - Phoenix, Arizona, United States, 85004
    - Cancer Center at Saint Joseph's
- Arkansas
  - Fort Smith, Arkansas, United States, 72903
    - Mercy Hospital Fort Smith
  - Hot Springs, Arkansas, United States, 71913
    - CHI Saint Vincent Cancer Center Hot Springs
- California
  - Antioch, California, United States, 94531
    - Kaiser Permanente-Deer Valley Medical Center
  - Arroyo Grande, California, United States, 93420
    - PCR Oncology
  - Arroyo Grande, California, United States, 93420
    - Mission Hope Medical Oncology - Arroyo Grande
  - Auburn, California, United States, 95602
    - Sutter Auburn Faith Hospital
  - Auburn, California, United States, 95603
    - Sutter Cancer Centers Radiation Oncology Services-Auburn
  - Berkeley, California, United States, 94704
    - Alta Bates Summit Medical Center-Herrick Campus
  - Burlingame, California, United States, 94010
    - Mills-Peninsula Medical Center
  - Cameron Park, California, United States, 95682
    - Sutter Cancer Centers Radiation Oncology Services-Cameron Park
  - Castro Valley, California, United States, 94546
    - Eden Hospital Medical Center
  - Davis, California, United States, 95616
    - Sutter Davis Hospital
  - Dublin, California, United States, 94568
    - Kaiser Permanente Dublin
  - Fremont, California, United States, 94538
    - Kaiser Permanente-Fremont
  - Fremont, California, United States, 94538
    - Palo Alto Medical Foundation-Fremont
  - Fresno, California, United States, 93720
    - Kaiser Permanente-Fresno
  - Los Angeles, California, United States, 90033
    - USC / Norris Comprehensive Cancer Center
  - Los Angeles, California, United States, 90033
    - Los Angeles County-USC Medical Center
  - Los Angeles, California, United States, 90048
    - Cedars Sinai Medical Center
  - Modesto, California, United States, 95355
    - Memorial Medical Center
  - Modesto, California, United States, 95356
    - Kaiser Permanente-Modesto
  - Mountain View, California, United States, 94040
    - Palo Alto Medical Foundation-Camino Division
  - Mountain View, California, United States, 94040
    - Palo Alto Medical Foundation-Gynecologic Oncology
  - Newport Beach, California, United States, 92663
    - USC Norris Oncology/Hematology-Newport Beach
  - Novato, California, United States, 94945
    - Sutter Cancer Research Consortium
  - Oakland, California, United States, 94611
    - Kaiser Permanente-Oakland
  - Palo Alto, California, United States, 94304
    - Stanford Cancer Institute Palo Alto
  - Palo Alto, California, United States, 94301
    - Palo Alto Medical Foundation Health Care
  - Pasadena, California, United States, 91105
    - Keck Medical Center of USC Pasadena
  - Rancho Mirage, California, United States, 92270
    - Eisenhower Medical Center
  - Redwood City, California, United States, 94063
    - Kaiser Permanente-Redwood City
  - Richmond, California, United States, 94801
    - Kaiser Permanente-Richmond
  - Roseville, California, United States, 95661
    - Kaiser Permanente-Roseville
  - Roseville, California, United States, 95661
    - Sutter Cancer Centers Radiation Oncology Services-Roseville
  - Roseville, California, United States, 95661
    - Sutter Roseville Medical Center
  - Sacramento, California, United States, 95816
    - Sutter Medical Center Sacramento
  - Sacramento, California, United States, 95814
    - Kaiser Permanente Downtown Commons
  - Sacramento, California, United States, 95823
    - Kaiser Permanente-South Sacramento
  - Sacramento, California, United States, 95825
    - Kaiser Permanente - Sacramento
  - San Francisco, California, United States, 94115
    - Kaiser Permanente-San Francisco
  - San Francisco, California, United States, 94158
    - UCSF Medical Center-Mission Bay
  - San Francisco, California, United States, 94115
    - California Pacific Medical Center-Pacific Campus
  - San Jose, California, United States, 95119
    - Kaiser Permanente-Santa Teresa-San Jose
  - San Leandro, California, United States, 94577
    - Kaiser Permanente San Leandro
  - San Luis Obispo, California, United States, 93401
    - Pacific Central Coast Health Center-San Luis Obispo
  - San Rafael, California, United States, 94903
    - Kaiser San Rafael-Gallinas
  - San Rafael, California, United States, 94903
    - Kaiser Permanente-San Rafael
  - Santa Clara, California, United States, 95051
    - Kaiser Permanente Medical Center - Santa Clara
  - Santa Cruz, California, United States, 95065
    - Palo Alto Medical Foundation-Santa Cruz
  - Santa Maria, California, United States, 93444
    - Mission Hope Medical Oncology - Santa Maria
  - Santa Rosa, California, United States, 95403
    - Kaiser Permanente-Santa Rosa
  - Santa Rosa, California, United States, 95403
    - Sutter Pacific Medical Foundation
  - South San Francisco, California, United States, 94080
    - Kaiser Permanente-South San Francisco
  - Stockton, California, United States, 95210
    - Kaiser Permanente-Stockton
  - Sunnyvale, California, United States, 94086
    - Palo Alto Medical Foundation-Sunnyvale
  - Vacaville, California, United States, 95688
    - Kaiser Permanente Medical Center-Vacaville
  - Vacaville, California, United States, 95687
    - Sutter Cancer Centers Radiation Oncology Services-Vacaville
  - Vallejo, California, United States, 94589
    - Kaiser Permanente-Vallejo
  - Vallejo, California, United States, 94589
    - Sutter Solano Medical Center/Cancer Center
  - Walnut Creek, California, United States, 94596
    - Kaiser Permanente-Walnut Creek
- Colorado
  - Aurora, Colorado, United States, 80045
    - University of Colorado Hospital
  - Colorado Springs, Colorado, United States, 80907
    - Penrose-Saint Francis Healthcare
  - Colorado Springs, Colorado, United States, 80907
    - Rocky Mountain Cancer Centers-Penrose
  - Denver, Colorado, United States, 80210
    - Porter Adventist Hospital
  - Durango, Colorado, United States, 81301
    - Mercy Medical Center
  - Durango, Colorado, United States, 81301
    - Southwest Oncology PC
  - Golden, Colorado, United States, 80401
    - Mountain Blue Cancer Care Center
  - Lakewood, Colorado, United States, 80228
    - Saint Anthony Hospital
  - Lakewood, Colorado, United States, 80228
    - Rocky Mountain Cancer Centers-Lakewood
  - Littleton, Colorado, United States, 80122
    - Littleton Adventist Hospital
  - Longmont, Colorado, United States, 80501
    - Longmont United Hospital
  - Longmont, Colorado, United States, 80501
    - Rocky Mountain Cancer Centers-Longmont
  - Parker, Colorado, United States, 80138
    - Parker Adventist Hospital
  - Parker, Colorado, United States, 80138
    - Rocky Mountain Cancer Centers-Parker
  - Pueblo, Colorado, United States, 81004
    - Saint Mary Corwin Medical Center
  - Pueblo, Colorado, United States, 81008
    - Rocky Mountain Cancer Centers - Pueblo
  - Thornton, Colorado, United States, 80260
    - Rocky Mountain Cancer Centers-Thornton
- Delaware
  - Frankford, Delaware, United States, 19945
    - Beebe South Coastal Health Campus
  - Lewes, Delaware, United States, 19958
    - Beebe Medical Center
  - Newark, Delaware, United States, 19713
    - Helen F Graham Cancer Center
  - Newark, Delaware, United States, 19713
    - Delaware Clinical and Laboratory Physicians PA
  - Newark, Delaware, United States, 19713
    - Medical Oncology Hematology Consultants PA
  - Newark, Delaware, United States, 19718
    - Christiana Care Health System-Christiana Hospital
  - Newark, Delaware, United States, 19713
    - Christiana Gynecologic Oncology LLC
  - Rehoboth Beach, Delaware, United States, 19971
    - Beebe Health Campus
  - Seaford, Delaware, United States, 19973
    - TidalHealth Nanticoke / Allen Cancer Center
  - Wilmington, Delaware, United States, 19801
    - Christiana Care Health System-Wilmington Hospital
- District of Columbia
  - Washington, District of Columbia, United States, 20010
    - MedStar Washington Hospital Center
  - Washington, District of Columbia, United States, 20016
    - Sibley Memorial Hospital
- Florida
  - Fort Lauderdale, Florida, United States, 33308
    - Holy Cross Hospital
- Georgia
  - Atlanta, Georgia, United States, 30308
    - Emory University Hospital Midtown
  - Atlanta, Georgia, United States, 30322
    - Emory University Hospital/Winship Cancer Institute
  - Atlanta, Georgia, United States, 30342
    - Emory Saint Joseph's Hospital
  - Atlanta, Georgia, United States, 30303
    - Grady Health System
  - Johns Creek, Georgia, United States, 30097
    - Emory Johns Creek Hospital
  - Macon, Georgia, United States, 31201
    - Medical Center of Central Georgia
- Hawaii
  - Honolulu, Hawaii, United States, 96819
    - Kaiser Permanente Moanalua Medical Center
- Idaho
  - Boise, Idaho, United States, 83706
    - Saint Alphonsus Cancer Care Center-Boise
  - Caldwell, Idaho, United States, 83605
    - Saint Alphonsus Cancer Care Center-Caldwell
  - Coeur d'Alene, Idaho, United States, 83814
    - Kootenai Health - Coeur d'Alene
  - Emmett, Idaho, United States, 83617
    - Walter Knox Memorial Hospital
  - Meridian, Idaho, United States, 83642
    - Idaho Urologic Institute-Meridian
  - Nampa, Idaho, United States, 83687
    - Saint Alphonsus Cancer Care Center-Nampa
  - Post Falls, Idaho, United States, 83854
    - Kootenai Clinic Cancer Services - Post Falls
  - Sandpoint, Idaho, United States, 83864
    - Kootenai Cancer Clinic
- Illinois
  - Aurora, Illinois, United States, 60504
    - Rush - Copley Medical Center
  - Bloomington, Illinois, United States, 61704
    - Illinois CancerCare-Bloomington
  - Bloomington, Illinois, United States, 61701
    - Saint Joseph Medical Center
  - Burr Ridge, Illinois, United States, 60527
    - Loyola Center for Health at Burr Ridge
  - Canton, Illinois, United States, 61520
    - Illinois CancerCare-Canton
  - Carbondale, Illinois, United States, 62902
    - Memorial Hospital of Carbondale
  - Carterville, Illinois, United States, 62918
    - SIH Cancer Institute
  - Carthage, Illinois, United States, 62321
    - Illinois CancerCare-Carthage
  - Centralia, Illinois, United States, 62801
    - Centralia Oncology Clinic
  - Chicago, Illinois, United States, 60611
    - Northwestern University
  - Chicago, Illinois, United States, 60612
    - Rush University Medical Center
  - Chicago, Illinois, United States, 60637
    - University of Chicago Comprehensive Cancer Center
  - Danville, Illinois, United States, 61832
    - Carle on Vermilion
  - DeKalb, Illinois, United States, 60115
    - Northwestern Medicine Cancer Center Kishwaukee
  - Decatur, Illinois, United States, 62526
    - Decatur Memorial Hospital
  - Decatur, Illinois, United States, 62526
    - Cancer Care Specialists of Illinois - Decatur
  - Dixon, Illinois, United States, 61021
    - Illinois CancerCare-Dixon
  - Effingham, Illinois, United States, 62401
    - Crossroads Cancer Center
  - Effingham, Illinois, United States, 62401
    - Carle Physician Group-Effingham
  - Eureka, Illinois, United States, 61530
    - Illinois CancerCare-Eureka
  - Galesburg, Illinois, United States, 61401
    - Western Illinois Cancer Treatment Center
  - Galesburg, Illinois, United States, 61401
    - Illinois CancerCare-Galesburg
  - Geneva, Illinois, United States, 60134
    - Northwestern Medicine Cancer Center Delnor
  - Homer Glen, Illinois, United States, 60491
    - Loyola Medicine Homer Glen
  - Kewanee, Illinois, United States, 61443
    - Illinois CancerCare-Kewanee Clinic
  - Lake Forest, Illinois, United States, 60045
    - Northwestern Medicine Lake Forest Hospital
  - Macomb, Illinois, United States, 61455
    - Illinois CancerCare-Macomb
  - Mattoon, Illinois, United States, 61938
    - Carle Physician Group-Mattoon/Charleston
  - Maywood, Illinois, United States, 60153
    - Loyola University Medical Center
  - Melrose Park, Illinois, United States, 60160
    - Marjorie Weinberg Cancer Center at Loyola-Gottlieb
  - Mount Vernon, Illinois, United States, 62864
    - Good Samaritan Regional Health Center
  - New Lenox, Illinois, United States, 60451
    - UC Comprehensive Cancer Center at Silver Cross
  - O'Fallon, Illinois, United States, 62269
    - Cancer Care Center of O'Fallon
  - Orland Park, Illinois, United States, 60462
    - University of Chicago Medicine-Orland Park
  - Ottawa, Illinois, United States, 61350
    - Illinois CancerCare-Ottawa Clinic
  - Ottawa, Illinois, United States, 61350
    - Radiation Oncology of Northern Illinois
  - Pekin, Illinois, United States, 61554
    - Illinois CancerCare-Pekin
  - Pekin, Illinois, United States, 61554
    - OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center
  - Peoria, Illinois, United States, 61636
    - Methodist Medical Center of Illinois
  - Peoria, Illinois, United States, 61637
    - OSF Saint Francis Medical Center
  - Peoria, Illinois, United States, 61615
    - Illinois CancerCare-Peoria
  - Peoria, Illinois, United States, 61615
    - OSF Saint Francis Radiation Oncology at Peoria Cancer Center
  - Peru, Illinois, United States, 61354
    - Illinois CancerCare-Peru
  - Peru, Illinois, United States, 61354
    - Valley Radiation Oncology
  - Princeton, Illinois, United States, 61356
    - Illinois CancerCare-Princeton
  - Springfield, Illinois, United States, 62781
    - Memorial Medical Center
  - Springfield, Illinois, United States, 62702
    - Southern Illinois University School of Medicine
  - Springfield, Illinois, United States, 62702
    - Springfield Clinic
  - Springfield, Illinois, United States, 62702
    - Central Illinois Hematology Oncology Center
  - Swansea, Illinois, United States, 62226
    - Southwest Illinois Health Services LLP
  - Urbana, Illinois, United States, 61801
    - Carle Cancer Center
  - Urbana, Illinois, United States, 61801
    - The Carle Foundation Hospital
  - Warrenville, Illinois, United States, 60555
    - Northwestern Medicine Cancer Center Warrenville
  - Yorkville, Illinois, United States, 60560
    - Rush-Copley Healthcare Center
- Indiana
  - Evansville, Indiana, United States, 47713
    - Deaconess Clinic Downtown
  - Michigan City, Indiana, United States, 46360
    - Franciscan Saint Anthony Health-Michigan City
  - Michigan City, Indiana, United States, 46360
    - Woodland Cancer Care Center
  - Newburgh, Indiana, United States, 47630
    - Chancellor Center for Oncology
  - Richmond, Indiana, United States, 47374
    - Reid Health
- Iowa
  - Ames, Iowa, United States, 50010
    - McFarland Clinic PC - Ames
  - Ames, Iowa, United States, 50010
    - Mary Greeley Medical Center
  - Boone, Iowa, United States, 50036
    - McFarland Clinic PC-Boone
  - Clive, Iowa, United States, 50325
    - Mercy Cancer Center-West Lakes
  - Clive, Iowa, United States, 50325
    - Medical Oncology and Hematology Associates-West Des Moines
  - Council Bluffs, Iowa, United States, 51503
    - Alegent Health Mercy Hospital
  - Creston, Iowa, United States, 50801
    - Greater Regional Medical Center
  - Des Moines, Iowa, United States, 50314
    - Mercy Medical Center - Des Moines
  - Des Moines, Iowa, United States, 50314
    - Mission Cancer and Blood - Laurel
  - Fort Dodge, Iowa, United States, 50501
    - McFarland Clinic PC-Trinity Cancer Center
  - Jefferson, Iowa, United States, 50129
    - McFarland Clinic PC-Jefferson
  - Marshalltown, Iowa, United States, 50158
    - McFarland Clinic PC-Marshalltown
  - Sioux City, Iowa, United States, 51101
    - Siouxland Regional Cancer Center
  - West Des Moines, Iowa, United States, 50266
    - Mercy Medical Center-West Lakes
- Kansas
  - Chanute, Kansas, United States, 66720
    - Cancer Center of Kansas - Chanute
  - Coffeyville, Kansas, United States, 67337
    - Coffeyville Regional Medical Center
  - Dodge City, Kansas, United States, 67801
    - Cancer Center of Kansas - Dodge City
  - El Dorado, Kansas, United States, 67042
    - Cancer Center of Kansas - El Dorado
  - Fort Scott, Kansas, United States, 66701
    - Cancer Center of Kansas - Fort Scott
  - Garden City, Kansas, United States, 67846
    - Central Care Cancer Center - Garden City
  - Great Bend, Kansas, United States, 67530
    - Central Care Cancer Center - Great Bend
  - Hays, Kansas, United States, 67601
    - HaysMed University of Kansas Health System
  - Independence, Kansas, United States, 67301
    - Cancer Center of Kansas-Independence
  - Kansas City, Kansas, United States, 66160
    - University of Kansas Cancer Center
  - Kingman, Kansas, United States, 67068
    - Cancer Center of Kansas-Kingman
  - Lawrence, Kansas, United States, 66044
    - Lawrence Memorial Hospital
  - Lenexa, Kansas, United States, 66219
    - Kansas Institute of Medicine Cancer and Blood Center
  - Lenexa, Kansas, United States, 66219
    - Minimally Invasive Surgery Hospital
  - Liberal, Kansas, United States, 67905
    - Cancer Center of Kansas-Liberal
  - Manhattan, Kansas, United States, 66502
    - Cancer Center of Kansas-Manhattan
  - McPherson, Kansas, United States, 67460
    - Cancer Center of Kansas - McPherson
  - Newton, Kansas, United States, 67114
    - Cancer Center of Kansas - Newton
  - Olathe, Kansas, United States, 66061
    - Olathe Health Cancer Center
  - Overland Park, Kansas, United States, 66210
    - University of Kansas Cancer Center-Overland Park
  - Overland Park, Kansas, United States, 66209
    - Menorah Medical Center
  - Parsons, Kansas, United States, 67357
    - Cancer Center of Kansas - Parsons
  - Pittsburg, Kansas, United States, 66762
    - Ascension Via Christi - Pittsburg
  - Pratt, Kansas, United States, 67124
    - Cancer Center of Kansas - Pratt
  - Salina, Kansas, United States, 67401
    - Salina Regional Health Center
  - Salina, Kansas, United States, 67401
    - Cancer Center of Kansas - Salina
  - Topeka, Kansas, United States, 66606
    - University of Kansas Health System Saint Francis Campus
  - Wellington, Kansas, United States, 67152
    - Cancer Center of Kansas - Wellington
  - Westwood, Kansas, United States, 66205
    - University of Kansas Hospital-Westwood Cancer Center
  - Wichita, Kansas, United States, 67214
    - Ascension Via Christi Hospitals Wichita
  - Wichita, Kansas, United States, 67208
    - Cancer Center of Kansas-Wichita Medical Arts Tower
  - Wichita, Kansas, United States, 67214
    - Cancer Center of Kansas - Wichita
  - Wichita, Kansas, United States, 67208
    - Associates In Womens Health
  - Winfield, Kansas, United States, 67156
    - Cancer Center of Kansas - Winfield
- Kentucky
  - Bardstown, Kentucky, United States, 40004
    - Flaget Memorial Hospital
  - Corbin, Kentucky, United States, 40701
    - Commonwealth Cancer Center-Corbin
  - Crestview Hills, Kentucky, United States, 41017
    - Oncology Hematology Care Inc-Crestview
  - Lexington, Kentucky, United States, 40536
    - University of Kentucky/Markey Cancer Center
  - Lexington, Kentucky, United States, 40504
    - Saint Joseph Radiation Oncology Resource Center
  - Lexington, Kentucky, United States, 40509
    - Saint Joseph Hospital East
  - London, Kentucky, United States, 40741
    - Saint Joseph London
  - Louisville, Kentucky, United States, 40202
    - Jewish Hospital
  - Louisville, Kentucky, United States, 40245
    - UofL Health Medical Center Northeast
  - Louisville, Kentucky, United States, 40215
    - Saints Mary and Elizabeth Hospital
  - Shepherdsville, Kentucky, United States, 40165
    - Jewish Hospital Medical Center South
- Louisiana
  - Alexandria, Louisiana, United States, 71301
    - Christus Saint Frances Cabrini Hospital
  - Baton Rouge, Louisiana, United States, 70809
    - Ochsner Health Center-Summa
  - Baton Rouge, Louisiana, United States, 70816
    - Medical Center of Baton Rouge
  - Baton Rouge, Louisiana, United States, 70836
    - Ochsner High Grove
  - Kenner, Louisiana, United States, 70065
    - Ochsner Medical Center Kenner
  - Lake Charles, Louisiana, United States, 70605
    - CHRISTUS Lake Charles Medical Center
  - Monroe, Louisiana, United States, 71202
    - Ochsner LSU Health Monroe Medical Center
  - New Orleans, Louisiana, United States, 70121
    - Ochsner Medical Center Jefferson
  - Shreveport, Louisiana, United States, 71103
    - LSU Health Sciences Center at Shreveport
- Maryland
  - Baltimore, Maryland, United States, 21287
    - Johns Hopkins University/Sidney Kimmel Cancer Center
  - Baltimore, Maryland, United States, 21215
    - Sinai Hospital of Baltimore
  - Randallstown, Maryland, United States, 21133
    - Northwest Hospital Center
  - Westminster, Maryland, United States, 21157
    - William E Kahlert Regional Cancer Center/Sinai Hospital
- Massachusetts
  - Boston, Massachusetts, United States, 02215
    - Beth Israel Deaconess Medical Center
  - Boston, Massachusetts, United States, 02215
    - Dana-Farber Cancer Institute
  - Boston, Massachusetts, United States, 02114
    - Massachusetts General Hospital Cancer Center
  - Springfield, Massachusetts, United States, 01104
    - Mercy Medical Center
- Michigan
  - Ann Arbor, Michigan, United States, 48109
    - University of Michigan Comprehensive Cancer Center
  - Ann Arbor, Michigan, United States, 48106
    - Saint Joseph Mercy Hospital
  - Battle Creek, Michigan, United States, 49017
    - Bronson Battle Creek
  - Brighton, Michigan, United States, 48114
    - Saint Joseph Mercy Brighton
  - Brighton, Michigan, United States, 48114
    - Trinity Health IHA Medical Group Hematology Oncology - Brighton
  - Brownstown, Michigan, United States, 48183
    - Henry Ford Cancer Institute-Downriver
  - Canton, Michigan, United States, 48188
    - Saint Joseph Mercy Canton
  - Canton, Michigan, United States, 48188
    - Trinity Health IHA Medical Group Hematology Oncology - Canton
  - Caro, Michigan, United States, 48723
    - Caro Cancer Center
  - Chelsea, Michigan, United States, 48118
    - Saint Joseph Mercy Chelsea
  - Chelsea, Michigan, United States, 48118
    - Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
  - Clarkston, Michigan, United States, 48346
    - Hematology Oncology Consultants-Clarkston
  - Clarkston, Michigan, United States, 48346
    - Newland Medical Associates-Clarkston
  - Clinton Township, Michigan, United States, 48038
    - Henry Ford Macomb Hospital-Clinton Township
  - Dearborn, Michigan, United States, 48126
    - Henry Ford Medical Center-Fairlane
  - Detroit, Michigan, United States, 48202
    - Henry Ford Hospital
  - Detroit, Michigan, United States, 48201
    - Wayne State University/Karmanos Cancer Institute
  - Detroit, Michigan, United States, 48236
    - Ascension Saint John Hospital
  - East China Township, Michigan, United States, 48054
    - Great Lakes Cancer Management Specialists-Doctors Park
  - Farmington Hills, Michigan, United States, 48334
    - Weisberg Cancer Treatment Center
  - Flint, Michigan, United States, 48503
    - Hurley Medical Center
  - Flint, Michigan, United States, 48503
    - Genesee Cancer and Blood Disease Treatment Center
  - Flint, Michigan, United States, 48503
    - Genesee Hematology Oncology PC
  - Flint, Michigan, United States, 48503
    - Genesys Hurley Cancer Institute
  - Grand Rapids, Michigan, United States, 49503
    - Spectrum Health at Butterworth Campus
  - Grand Rapids, Michigan, United States, 49503
    - Helen DeVos Children's Hospital at Spectrum Health
  - Grand Rapids, Michigan, United States, 49503
    - Trinity Health Grand Rapids Hospital
  - Grosse Pointe Woods, Michigan, United States, 48236
    - Academic Hematology Oncology Specialists
  - Grosse Pointe Woods, Michigan, United States, 48236
    - Great Lakes Cancer Management Specialists-Van Elslander Cancer Center
  - Grosse Pointe Woods, Michigan, United States, 48236
    - Michigan Breast Specialists-Grosse Pointe Woods
  - Jackson, Michigan, United States, 49201
    - Allegiance Health
  - Kalamazoo, Michigan, United States, 49007
    - West Michigan Cancer Center
  - Kalamazoo, Michigan, United States, 49007
    - Bronson Methodist Hospital
  - Kalamazoo, Michigan, United States, 49048
    - Borgess Medical Center
  - Lansing, Michigan, United States, 48912
    - Sparrow Hospital
  - Livonia, Michigan, United States, 48154
    - Trinity Health Saint Mary Mercy Livonia Hospital
  - Livonia, Michigan, United States, 48154
    - Hope Cancer Clinic
  - Macomb, Michigan, United States, 48044
    - Great Lakes Cancer Management Specialists-Macomb Medical Campus
  - Macomb, Michigan, United States, 48044
    - Michigan Breast Specialists-Macomb Township
  - Marlette, Michigan, United States, 48453
    - Saint Mary's Oncology/Hematology Associates of Marlette
  - Monroe, Michigan, United States, 48162
    - Monroe Cancer Center
  - Muskegon, Michigan, United States, 49444
    - Trinity Health Muskegon Hospital
  - Niles, Michigan, United States, 49120
    - Lakeland Hospital Niles
  - Norton Shores, Michigan, United States, 49444
    - Cancer and Hematology Centers of Western Michigan - Norton Shores
  - Novi, Michigan, United States, 48377
    - Henry Ford Medical Center-Columbus
  - Pontiac, Michigan, United States, 48341
    - Saint Joseph Mercy Oakland
  - Pontiac, Michigan, United States, 48341
    - 21st Century Oncology-Pontiac
  - Pontiac, Michigan, United States, 48341
    - Hope Cancer Center
  - Pontiac, Michigan, United States, 48341
    - Newland Medical Associates-Pontiac
  - Port Huron, Michigan, United States, 48060
    - Lake Huron Medical Center
  - Port Huron, Michigan, United States, 48060
    - Huron Medical Center PC
  - Reed City, Michigan, United States, 49677
    - Spectrum Health Reed City Hospital
  - Rochester Hills, Michigan, United States, 48309
    - Great Lakes Cancer Management Specialists-Rochester Hills
  - Saginaw, Michigan, United States, 48601
    - Ascension Saint Mary's Hospital
  - Saginaw, Michigan, United States, 48604
    - Oncology Hematology Associates of Saginaw Valley PC
  - Saint Joseph, Michigan, United States, 49085
    - Lakeland Medical Center Saint Joseph
  - Saint Joseph, Michigan, United States, 49085
    - Marie Yeager Cancer Center
  - Shelby, Michigan, United States, 48315
    - Henry Ford Macomb Health Center - Shelby Township
  - Sterling Heights, Michigan, United States, 48312
    - Bhadresh Nayak MD PC-Sterling Heights
  - Tawas City, Michigan, United States, 48764
    - Ascension Saint Joseph Hospital
  - Traverse City, Michigan, United States, 49684
    - Munson Medical Center
  - Warren, Michigan, United States, 48093
    - Saint John Macomb-Oakland Hospital
  - Warren, Michigan, United States, 48088
    - Advanced Breast Care Center PLLC
  - Warren, Michigan, United States, 48093
    - Great Lakes Cancer Management Specialists-Macomb Professional Building
  - Warren, Michigan, United States, 48093
    - Macomb Hematology Oncology PC
  - Warren, Michigan, United States, 48093
    - Michigan Breast Specialists-Warren
  - West Bloomfield, Michigan, United States, 48322
    - Henry Ford West Bloomfield Hospital
  - West Branch, Michigan, United States, 48661
    - Saint Mary's Oncology/Hematology Associates of West Branch
  - Wyoming, Michigan, United States, 49519
    - Metro Health Hospital
  - Ypsilanti, Michigan, United States, 48197
    - Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
  - Ypsilanti, Michigan, United States, 48106
    - Huron Gastroenterology PC
- Minnesota
  - Bemidji, Minnesota, United States, 56601
    - Sanford Joe Lueken Cancer Center
  - Burnsville, Minnesota, United States, 55337
    - Fairview Ridges Hospital
  - Burnsville, Minnesota, United States, 55337
    - Minnesota Oncology - Burnsville
  - Cambridge, Minnesota, United States, 55008
    - Cambridge Medical Center
  - Coon Rapids, Minnesota, United States, 55433
    - Mercy Hospital
  - Edina, Minnesota, United States, 55435
    - Fairview Southdale Hospital
  - Fridley, Minnesota, United States, 55432
    - Unity Hospital
  - Maple Grove, Minnesota, United States, 55369
    - Fairview Clinics and Surgery Center Maple Grove
  - Maplewood, Minnesota, United States, 55109
    - Saint John's Hospital - Healtheast
  - Maplewood, Minnesota, United States, 55109
    - Minnesota Oncology Hematology PA-Maplewood
  - Minneapolis, Minnesota, United States, 55415
    - Hennepin County Medical Center
  - Minneapolis, Minnesota, United States, 55407
    - Abbott-Northwestern Hospital
  - Minneapolis, Minnesota, United States, 55454
    - Health Partners Inc
  - Monticello, Minnesota, United States, 55362
    - Monticello Cancer Center
  - New Ulm, Minnesota, United States, 56073
    - New Ulm Medical Center
  - Princeton, Minnesota, United States, 55371
    - Fairview Northland Medical Center
  - Robbinsdale, Minnesota, United States, 55422
    - North Memorial Medical Health Center
  - Rochester, Minnesota, United States, 55905
    - Mayo Clinic in Rochester
  - Saint Louis Park, Minnesota, United States, 55416
    - Park Nicollet Clinic - Saint Louis Park
  - Saint Paul, Minnesota, United States, 55101
    - Regions Hospital
  - Saint Paul, Minnesota, United States, 55102
    - United Hospital
  - Shakopee, Minnesota, United States, 55379
    - Saint Francis Regional Medical Center
  - Stillwater, Minnesota, United States, 55082
    - Lakeview Hospital
  - Thief River Falls, Minnesota, United States, 56701
    - Sanford Thief River Falls Medical Center
  - Waconia, Minnesota, United States, 55387
    - Ridgeview Medical Center
  - Willmar, Minnesota, United States, 56201
    - Rice Memorial Hospital
  - Woodbury, Minnesota, United States, 55125
    - Minnesota Oncology Hematology PA-Woodbury
  - Worthington, Minnesota, United States, 56187
    - Sanford Cancer Center Worthington
  - Wyoming, Minnesota, United States, 55092
    - Fairview Lakes Medical Center
- Missouri
  - Ballwin, Missouri, United States, 63011
    - Saint Louis Cancer and Breast Institute-Ballwin
  - Bolivar, Missouri, United States, 65613
    - Central Care Cancer Center - Bolivar
  - Bonne Terre, Missouri, United States, 63628
    - Parkland Health Center-Bonne Terre
  - Branson, Missouri, United States, 65616
    - Cox Cancer Center Branson
  - Cape Girardeau, Missouri, United States, 63703
    - Saint Francis Medical Center
  - Cape Girardeau, Missouri, United States, 63703
    - Southeast Cancer Center
  - Creve Coeur, Missouri, United States, 63141
    - Siteman Cancer Center at West County Hospital
  - Farmington, Missouri, United States, 63640
    - Parkland Health Center - Farmington
  - Independence, Missouri, United States, 64057
    - Centerpoint Medical Center LLC
  - Jefferson City, Missouri, United States, 65109
    - Capital Region Southwest Campus
  - Joplin, Missouri, United States, 64804
    - Freeman Health System
  - Joplin, Missouri, United States, 64804
    - Mercy Hospital Joplin
  - Kansas City, Missouri, United States, 64154
    - University of Kansas Cancer Center - North
  - Kansas City, Missouri, United States, 64132
    - Research Medical Center
  - Kansas City, Missouri, United States, 64108
    - Truman Medical Centers
  - Lee's Summit, Missouri, United States, 64064
    - University of Kansas Cancer Center - Lee's Summit
  - Rolla, Missouri, United States, 65401
    - Delbert Day Cancer Institute at PCRMC
  - Rolla, Missouri, United States, 65401
    - Mercy Clinic-Rolla-Cancer and Hematology
  - Saint Joseph, Missouri, United States, 64506
    - Heartland Regional Medical Center
  - Saint Louis, Missouri, United States, 63110
    - Washington University School of Medicine
  - Saint Louis, Missouri, United States, 63131
    - Missouri Baptist Medical Center
  - Saint Louis, Missouri, United States, 63141
    - Mercy Hospital Saint Louis
  - Saint Louis, Missouri, United States, 63128
    - Mercy Hospital South
  - Saint Louis, Missouri, United States, 63129
    - Siteman Cancer Center-South County
  - Saint Louis, Missouri, United States, 63136
    - Siteman Cancer Center at Christian Hospital
  - Saint Louis, Missouri, United States, 63109
    - Saint Louis Cancer and Breast Institute-South City
  - Saint Peters, Missouri, United States, 63376
    - Siteman Cancer Center at Saint Peters Hospital
  - Sainte Genevieve, Missouri, United States, 63670
    - Sainte Genevieve County Memorial Hospital
  - Springfield, Missouri, United States, 65807
    - CoxHealth South Hospital
  - Springfield, Missouri, United States, 65804
    - Mercy Hospital Springfield
  - Sullivan, Missouri, United States, 63080
    - Missouri Baptist Sullivan Hospital
  - Sunset Hills, Missouri, United States, 63127
    - Missouri Baptist Outpatient Center-Sunset Hills
  - Washington, Missouri, United States, 63090
    - Mercy Hospital Washington
- Montana
  - Anaconda, Montana, United States, 59711
    - Community Hospital of Anaconda
  - Billings, Montana, United States, 59101
    - Billings Clinic Cancer Center
  - Billings, Montana, United States, 59101
    - Saint Vincent Healthcare
  - Bozeman, Montana, United States, 59715
    - Bozeman Deaconess Hospital
  - Butte, Montana, United States, 59701
    - Saint James Community Hospital and Cancer Treatment Center
  - Great Falls, Montana, United States, 59405
    - Great Falls Clinic
  - Great Falls, Montana, United States, 59405
    - Benefis Healthcare- Sletten Cancer Institute
  - Helena, Montana, United States, 59601
    - Saint Peter's Community Hospital
  - Kalispell, Montana, United States, 59901
    - Kalispell Regional Medical Center
  - Missoula, Montana, United States, 59804
    - Community Medical Hospital
  - Missoula, Montana, United States, 59802
    - Saint Patrick Hospital - Community Hospital
- Nebraska
  - Grand Island, Nebraska, United States, 68803
    - CHI Health Saint Francis
  - Kearney, Nebraska, United States, 68847
    - CHI Health Good Samaritan
  - Kearney, Nebraska, United States, 68845
    - Heartland Hematology and Oncology
  - Lincoln, Nebraska, United States, 68510
    - Saint Elizabeth Regional Medical Center
  - Omaha, Nebraska, United States, 68124
    - Alegent Health Bergan Mercy Medical Center
  - Omaha, Nebraska, United States, 68122
    - Alegent Health Immanuel Medical Center
  - Omaha, Nebraska, United States, 68130
    - Alegent Health Lakeside Hospital
  - Omaha, Nebraska, United States, 68131
    - Creighton University Medical Center
  - Omaha, Nebraska, United States, 68122
    - Hematology and Oncology Consultants PC
  - Papillion, Nebraska, United States, 68046
    - Midlands Community Hospital
- Nevada
  - Carson City, Nevada, United States, 89703
    - Carson Tahoe Regional Medical Center
  - Henderson, Nevada, United States, 89052
    - Comprehensive Cancer Centers of Nevada - Henderson
  - Henderson, Nevada, United States, 89052
    - OptumCare Cancer Care at Seven Hills
  - Henderson, Nevada, United States, 89052
    - Cancer and Blood Specialists-Henderson
  - Henderson, Nevada, United States, 89052
    - Las Vegas Cancer Center-Henderson
  - Henderson, Nevada, United States, 89074
    - Comprehensive Cancer Centers of Nevada-Southeast Henderson
  - Henderson, Nevada, United States, 89074
    - GenesisCare USA - Henderson
  - Henderson, Nevada, United States, 89052
    - Comprehensive Cancer Centers of Nevada-Horizon Ridge
  - Henderson, Nevada, United States, 89074
    - Las Vegas Urology - Green Valley
  - Henderson, Nevada, United States, 89074
    - Las Vegas Urology - Pebble
  - Henderson, Nevada, United States, 89074
    - Urology Specialists of Nevada - Green Valley
  - Las Vegas, Nevada, United States, 89144
    - Summerlin Hospital Medical Center
  - Las Vegas, Nevada, United States, 89109
    - Sunrise Hospital and Medical Center
  - Las Vegas, Nevada, United States, 89102
    - OptumCare Cancer Care at Charleston
  - Las Vegas, Nevada, United States, 89106
    - Radiation Oncology Centers of Nevada Central
  - Las Vegas, Nevada, United States, 89109
    - GenesisCare USA - Las Vegas
  - Las Vegas, Nevada, United States, 89119
    - Radiation Oncology Centers of Nevada Southeast
  - Las Vegas, Nevada, United States, 89128
    - Comprehensive Cancer Centers of Nevada - Northwest
  - Las Vegas, Nevada, United States, 89128
    - OptumCare Cancer Care at MountainView
  - Las Vegas, Nevada, United States, 89135
    - Alliance for Childhood Diseases/Cure 4 the Kids Foundation
  - Las Vegas, Nevada, United States, 89144
    - Comprehensive Cancer Centers of Nevada - Town Center
  - Las Vegas, Nevada, United States, 89144
    - Comprehensive Cancer Centers of Nevada-Summerlin
  - Las Vegas, Nevada, United States, 89148
    - Comprehensive Cancer Centers of Nevada
  - Las Vegas, Nevada, United States, 89148
    - OptumCare Cancer Care at Fort Apache
  - Las Vegas, Nevada, United States, 89169
    - Comprehensive Cancer Centers of Nevada - Central Valley
  - Las Vegas, Nevada, United States, 89102
    - University Medical Center of Southern Nevada
  - Las Vegas, Nevada, United States, 89106
    - Cancer and Blood Specialists-Shadow
  - Las Vegas, Nevada, United States, 89109
    - HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway
  - Las Vegas, Nevada, United States, 89113
    - HealthCare Partners Medical Group Oncology/Hematology-San Martin
  - Las Vegas, Nevada, United States, 89121
    - Cancer Therapy and Integrative Medicine
  - Las Vegas, Nevada, United States, 89128
    - Cancer and Blood Specialists-Tenaya
  - Las Vegas, Nevada, United States, 89128
    - GenesisCare USA - Vegas Tenaya
  - Las Vegas, Nevada, United States, 89128
    - HealthCare Partners Medical Group Oncology/Hematology-Tenaya
  - Las Vegas, Nevada, United States, 89148-2405
    - Las Vegas Cancer Center-Medical Center
  - Las Vegas, Nevada, United States, 89148
    - GenesisCare USA - Fort Apache
  - Las Vegas, Nevada, United States, 89149
    - HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills
  - Las Vegas, Nevada, United States, 89128
    - Ann M Wierman MD LTD
  - Las Vegas, Nevada, United States, 89074
    - Las Vegas Urology - Pecos
  - Las Vegas, Nevada, United States, 89102
    - Desert West Surgery
  - Las Vegas, Nevada, United States, 89103
    - Hope Cancer Care of Nevada
  - Las Vegas, Nevada, United States, 89106
    - Urology Specialists of Nevada - Central
  - Las Vegas, Nevada, United States, 89113
    - Las Vegas Prostate Cancer Center
  - Las Vegas, Nevada, United States, 89113
    - Las Vegas Urology - Sunset
  - Las Vegas, Nevada, United States, 89128
    - Las Vegas Urology - Cathedral Rock
  - Las Vegas, Nevada, United States, 89128
    - Las Vegas Urology - Smoke Ranch
  - Las Vegas, Nevada, United States, 89128
    - Urology Specialists of Nevada - Northwest
  - Las Vegas, Nevada, United States, 89169
    - University Cancer Center
  - Las Vegas, Nevada, United States, 89113
    - Urology Specialists of Nevada - Southwest
  - Pahrump, Nevada, United States, 89048
    - Hope Cancer Care of Nevada-Pahrump
  - Reno, Nevada, United States, 89502
    - Renown Regional Medical Center
  - Reno, Nevada, United States, 89503
    - Saint Mary's Regional Medical Center
  - Reno, Nevada, United States, 89509
    - Radiation Oncology Associates
- New Hampshire
  - Lebanon, New Hampshire, United States, 03756
    - Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
- New Jersey
  - Mullica Hill, New Jersey, United States, 08062
    - Inspira Medical Center Mullica Hill
  - Vineland, New Jersey, United States, 08360
    - Inspira Medical Center Vineland
- New Mexico
  - Albuquerque, New Mexico, United States, 87102
    - University of New Mexico Cancer Center
- New York
  - Bronx, New York, United States, 10461
    - Montefiore Medical Center-Einstein Campus
  - Bronx, New York, United States, 10467
    - Montefiore Medical Center - Moses Campus
  - Bronx, New York, United States, 10461
    - Montefiore Medical Center-Weiler Hospital
  - New York, New York, United States, 10032
    - NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
- North Carolina
  - Asheville, North Carolina, United States, 28803
    - AdventHealth Infusion Center Asheville
  - Cary, North Carolina, United States, 27518
    - Duke Cancer Institute Cary
  - Clinton, North Carolina, United States, 28328
    - Southeastern Medical Oncology Center-Clinton
  - Clyde, North Carolina, United States, 28721
    - AdventHealth Infusion Center Haywood
  - Durham, North Carolina, United States, 27710
    - Duke University Medical Center
  - Goldsboro, North Carolina, United States, 27534
    - Southeastern Medical Oncology Center-Goldsboro
  - Goldsboro, North Carolina, United States, 27534
    - Wayne Memorial Hospital
  - Hendersonville, North Carolina, United States, 28792
    - AdventHealth Hendersonville
  - Jacksonville, North Carolina, United States, 28546
    - Southeastern Medical Oncology Center-Jacksonville
  - Jacksonville, North Carolina, United States, 28546
    - Onslow Memorial Hospital
  - Raleigh, North Carolina, United States, 27609
    - Duke Raleigh Hospital
  - Washington, North Carolina, United States, 27889
    - Marion L Shepard Cancer Center at Vidant Beaufort Hospital
- North Dakota
  - Bismarck, North Dakota, United States, 58501
    - Sanford Bismarck Medical Center
  - Fargo, North Dakota, United States, 58122
    - Sanford Roger Maris Cancer Center
  - Fargo, North Dakota, United States, 58122
    - Sanford Broadway Medical Center
  - Fargo, North Dakota, United States, 58122
    - Sanford Clinic North-Fargo
  - Fargo, North Dakota, United States, 58103
    - Sanford South University Medical Center
- Ohio
  - Beachwood, Ohio, United States, 44122
    - UHHS-Chagrin Highlands Medical Center
  - Beavercreek, Ohio, United States, 45431
    - Indu and Raj Soin Medical Center
  - Belpre, Ohio, United States, 45714
    - Strecker Cancer Center-Belpre
  - Boardman, Ohio, United States, 44512
    - Saint Elizabeth Boardman Hospital
  - Centerville, Ohio, United States, 45459
    - Miami Valley Hospital South
  - Centerville, Ohio, United States, 45459
    - Dayton Physicians LLC-Miami Valley South
  - Chardon, Ohio, United States, 44024
    - Geauga Hospital
  - Chillicothe, Ohio, United States, 45601
    - Adena Regional Medical Center
  - Cincinnati, Ohio, United States, 45219
    - University of Cincinnati Cancer Center-UC Medical Center
  - Cincinnati, Ohio, United States, 45220
    - Good Samaritan Hospital - Cincinnati
  - Cincinnati, Ohio, United States, 45242
    - Bethesda North Hospital
  - Cincinnati, Ohio, United States, 45242
    - Oncology Hematology Care Inc-Blue Ash
  - Cincinnati, Ohio, United States, 45202
    - Oncology Hematology Care Inc-Eden Park
  - Cincinnati, Ohio, United States, 45211
    - Oncology Hematology Care Inc-Mercy West
  - Cincinnati, Ohio, United States, 45230
    - Oncology Hematology Care Inc-Anderson
  - Cincinnati, Ohio, United States, 45236
    - Oncology Hematology Care Inc-Kenwood
  - Cincinnati, Ohio, United States, 45247
    - TriHealth Cancer Institute-Westside
  - Cincinnati, Ohio, United States, 45255
    - TriHealth Cancer Institute-Anderson
  - Cleveland, Ohio, United States, 44106
    - Case Western Reserve University
  - Cleveland, Ohio, United States, 44109
    - MetroHealth Medical Center
  - Cleveland, Ohio, United States, 44195
    - Cleveland Clinic Foundation
  - Cleveland, Ohio, United States, 44111
    - Cleveland Clinic Cancer Center/Fairview Hospital
  - Columbus, Ohio, United States, 43214
    - Riverside Methodist Hospital
  - Columbus, Ohio, United States, 43210
    - Ohio State University Comprehensive Cancer Center
  - Columbus, Ohio, United States, 43219
    - The Mark H Zangmeister Center
  - Columbus, Ohio, United States, 43214
    - Columbus Oncology and Hematology Associates Inc
  - Columbus, Ohio, United States, 43228
    - Doctors Hospital
  - Columbus, Ohio, United States, 43213
    - Mount Carmel East Hospital
  - Columbus, Ohio, United States, 43215
    - Grant Medical Center
  - Columbus, Ohio, United States, 43222
    - Mount Carmel Health Center West
  - Dayton, Ohio, United States, 45406
    - Good Samaritan Hospital - Dayton
  - Dayton, Ohio, United States, 45409
    - Miami Valley Hospital
  - Dayton, Ohio, United States, 45415
    - Dayton Physician LLC-Miami Valley Hospital North
  - Dayton, Ohio, United States, 45415
    - Miami Valley Hospital North
  - Delaware, Ohio, United States, 43015
    - Delaware Health Center-Grady Cancer Center
  - Delaware, Ohio, United States, 43015
    - Delaware Radiation Oncology
  - Delaware, Ohio, United States, 43015
    - Grady Memorial Hospital
  - Dublin, Ohio, United States, 43016
    - Dublin Methodist Hospital
  - Elyria, Ohio, United States, 44035
    - Mercy Cancer Center-Elyria
  - Fairfield, Ohio, United States, 45014
    - Oncology Hematology Care Inc-Healthplex
  - Findlay, Ohio, United States, 45840
    - Blanchard Valley Hospital
  - Findlay, Ohio, United States, 45840
    - Armes Family Cancer Center
  - Findlay, Ohio, United States, 45840
    - Orion Cancer Care
  - Franklin, Ohio, United States, 45005-1066
    - Atrium Medical Center-Middletown Regional Hospital
  - Franklin, Ohio, United States, 45005
    - Dayton Physicians LLC-Atrium
  - Greenville, Ohio, United States, 45331
    - Wayne Hospital
  - Greenville, Ohio, United States, 45331
    - Dayton Physicians LLC-Wayne
  - Grove City, Ohio, United States, 43123
    - Mount Carmel Grove City Hospital
  - Independence, Ohio, United States, 44131
    - Cleveland Clinic Cancer Center Independence
  - Kettering, Ohio, United States, 45429
    - Kettering Medical Center
  - Kettering, Ohio, United States, 45409
    - Greater Dayton Cancer Center
  - Kettering, Ohio, United States, 45420
    - First Dayton Cancer Care
  - Lancaster, Ohio, United States, 43130
    - Fairfield Medical Center
  - Mansfield, Ohio, United States, 44903
    - OhioHealth Mansfield Hospital
  - Marietta, Ohio, United States, 45750
    - Marietta Memorial Hospital
  - Marion, Ohio, United States, 43302
    - OhioHealth Marion General Hospital
  - Mayfield Heights, Ohio, United States, 44124
    - Hillcrest Hospital Cancer Center
  - Mayfield Heights, Ohio, United States, 44124
    - UH Seidman Cancer Center at Landerbrook Health Center
  - Mentor, Ohio, United States, 44060
    - UH Seidman Cancer Center at Lake Health Mentor Campus
  - Middleburg Heights, Ohio, United States, 44130
    - UH Seidman Cancer Center at Southwest General Hospital
  - Middletown, Ohio, United States, 45042
    - Dayton Physicians LLC-Signal Point
  - Mount Vernon, Ohio, United States, 43050
    - Knox Community Hospital
  - Newark, Ohio, United States, 43055
    - Licking Memorial Hospital
  - Newark, Ohio, United States, 43055
    - Newark Radiation Oncology
  - Parma, Ohio, United States, 44129
    - University Hospitals Parma Medical Center
  - Portsmouth, Ohio, United States, 45662
    - Southern Ohio Medical Center
  - Sandusky, Ohio, United States, 44870
    - North Coast Cancer Care
  - Sandusky, Ohio, United States, 44870
    - UH Seidman Cancer Center at Firelands Regional Medical Center
  - Sidney, Ohio, United States, 45365
    - Dayton Physicians LLC-Wilson
  - Springfield, Ohio, United States, 45505
    - Springfield Regional Medical Center
  - Springfield, Ohio, United States, 45504
    - Springfield Regional Cancer Center
  - Strongsville, Ohio, United States, 44136
    - Cleveland Clinic Cancer Center Strongsville
  - Sylvania, Ohio, United States, 43560
    - ProMedica Flower Hospital
  - Toledo, Ohio, United States, 43606
    - ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
  - Troy, Ohio, United States, 45373
    - Upper Valley Medical Center
  - Troy, Ohio, United States, 45373
    - Dayton Physicians LLC - Troy
  - Wadsworth, Ohio, United States, 44281
    - University Hospitals Sharon Health Center
  - Warren, Ohio, United States, 44484
    - Saint Joseph Warren Hospital
  - Warrensville Heights, Ohio, United States, 44122
    - South Pointe Hospital
  - West Chester, Ohio, United States, 45069
    - University of Cincinnati Cancer Center-West Chester
  - Westerville, Ohio, United States, 43081
    - Saint Ann's Hospital
  - Westlake, Ohio, United States, 44145
    - UH Seidman Cancer Center at Saint John Medical Center
  - Westlake, Ohio, United States, 44145
    - UHHS-Westlake Medical Center
  - Wooster, Ohio, United States, 44691
    - Cleveland Clinic Wooster Family Health and Surgery Center
  - Youngstown, Ohio, United States, 44501
    - Saint Elizabeth Youngstown Hospital
  - Zanesville, Ohio, United States, 43701
    - Genesis Healthcare System Cancer Care Center
- Oklahoma
  - Lawton, Oklahoma, United States, 73505
    - Cancer Centers of Southwest Oklahoma Research
  - Oklahoma City, Oklahoma, United States, 73104
    - University of Oklahoma Health Sciences Center
  - Oklahoma City, Oklahoma, United States, 73120
    - Mercy Hospital Oklahoma City
- Oregon
  - Baker City, Oregon, United States, 97814
    - Saint Alphonsus Medical Center-Baker City
  - Ontario, Oregon, United States, 97914
    - Saint Alphonsus Medical Center-Ontario
- Pennsylvania
  - Allentown, Pennsylvania, United States, 18103
    - Lehigh Valley Hospital-Cedar Crest
  - Beaver, Pennsylvania, United States, 15009
    - UPMC-Heritage Valley Health System Beaver
  - Bethlehem, Pennsylvania, United States, 18017
    - Lehigh Valley Hospital - Muhlenberg
  - Chadds Ford, Pennsylvania, United States, 19317
    - Christiana Care Health System-Concord Health Center
  - Danville, Pennsylvania, United States, 17822
    - Geisinger Medical Center
  - East Stroudsburg, Pennsylvania, United States, 18301
    - Pocono Medical Center
  - Greensburg, Pennsylvania, United States, 15601
    - UPMC Cancer Centers - Arnold Palmer Pavilion
  - Hazleton, Pennsylvania, United States, 18201
    - Geisinger Medical Center-Cancer Center Hazleton
  - Hazleton, Pennsylvania, United States, 18201
    - Lehigh Valley Hospital-Hazleton
  - Hershey, Pennsylvania, United States, 17033-0850
    - Penn State Milton S Hershey Medical Center
  - Johnstown, Pennsylvania, United States, 15901
    - UPMC-Johnstown/John P. Murtha Regional Cancer Center
  - Lewisburg, Pennsylvania, United States, 17837
    - Geisinger Medical Oncology-Lewisburg
  - Lewistown, Pennsylvania, United States, 17044
    - Lewistown Hospital
  - McKeesport, Pennsylvania, United States, 15132
    - UPMC Cancer Center at UPMC McKeesport
  - Moon, Pennsylvania, United States, 15108
    - UPMC Hillman Cancer Center in Coraopolis
  - Philadelphia, Pennsylvania, United States, 19111
    - Fox Chase Cancer Center
  - Philadelphia, Pennsylvania, United States, 19104
    - University of Pennsylvania/Abramson Cancer Center
  - Pittsburgh, Pennsylvania, United States, 15213
    - UPMC-Magee Womens Hospital
  - Pittsburgh, Pennsylvania, United States, 15232
    - University of Pittsburgh Cancer Institute (UPCI)
  - Pittsburgh, Pennsylvania, United States, 15232
    - UPMC-Shadyside Hospital
  - Pittsburgh, Pennsylvania, United States, 15213
    - UPMC-Presbyterian Hospital
  - Pittsburgh, Pennsylvania, United States, 15215
    - UPMC-Saint Margaret
  - Pittsburgh, Pennsylvania, United States, 15236
    - UPMC Jefferson Regional Radiation Oncology
  - Pittsburgh, Pennsylvania, United States, 15237
    - UPMC-Passavant Hospital
  - Pittsburgh, Pennsylvania, United States, 15243
    - UPMC-Saint Clair Hospital Cancer Center
  - Pottsville, Pennsylvania, United States, 17901
    - Geisinger Cancer Services-Pottsville
  - Scranton, Pennsylvania, United States, 18510
    - Community Medical Center
  - Selinsgrove, Pennsylvania, United States, 17870
    - Geisinger Medical Oncology-Selinsgrove
  - Seneca, Pennsylvania, United States, 16346
    - UPMC Cancer Center at UPMC Northwest
  - State College, Pennsylvania, United States, 16801
    - Geisinger Medical Group
  - Uniontown, Pennsylvania, United States, 15401
    - UPMC Uniontown Hospital Radiation Oncology
  - Washington, Pennsylvania, United States, 15301
    - UPMC Washington Hospital Radiation Oncology
  - Wilkes-Barre, Pennsylvania, United States, 18711
    - Geisinger Wyoming Valley/Henry Cancer Center
- South Carolina
  - Anderson, South Carolina, United States, 29621
    - AnMed Health Cancer Center
  - Boiling Springs, South Carolina, United States, 29316
    - Prisma Health Cancer Institute - Spartanburg
  - Charleston, South Carolina, United States, 29425
    - Medical University of South Carolina
  - Easley, South Carolina, United States, 29640
    - Prisma Health Cancer Institute - Easley
  - Greenville, South Carolina, United States, 29605
    - Prisma Health Cancer Institute - Faris
  - Greenville, South Carolina, United States, 29615
    - Prisma Health Cancer Institute - Eastside
  - Greenville, South Carolina, United States, 29605
    - Prisma Health Cancer Institute - Butternut
  - Greenville, South Carolina, United States, 29605
    - Prisma Health Greenville Memorial Hospital
  - Greer, South Carolina, United States, 29650
    - Prisma Health Cancer Institute - Greer
  - Seneca, South Carolina, United States, 29672
    - Prisma Health Cancer Institute - Seneca
- South Dakota
  - Sioux Falls, South Dakota, United States, 57117-5134
    - Sanford USD Medical Center - Sioux Falls
  - Sioux Falls, South Dakota, United States, 57104
    - Sanford Cancer Center Oncology Clinic
- Tennessee
  - Chattanooga, Tennessee, United States, 37404
    - Memorial Hospital
  - Hixson, Tennessee, United States, 37343
    - Pulmonary Medicine Center of Chattanooga-Hixson
  - Ooltewah, Tennessee, United States, 37363
    - Memorial GYN Plus
- Texas
  - Bryan, Texas, United States, 77802
    - Saint Joseph Regional Cancer Center
  - Dallas, Texas, United States, 75235
    - Parkland Memorial Hospital
  - Dallas, Texas, United States, 75390
    - UT Southwestern/Simmons Cancer Center-Dallas
  - Fort Worth, Texas, United States, 76104
    - UT Southwestern/Simmons Cancer Center-Fort Worth
  - Houston, Texas, United States, 77030
    - Houston Methodist Hospital
  - Houston, Texas, United States, 77070
    - Methodist Willowbrook Hospital
  - Richardson, Texas, United States, 75080
    - UT Southwestern Clinical Center at Richardson/Plano
  - San Antonio, Texas, United States, 78229
    - University of Texas Health Science Center at San Antonio
  - Sugar Land, Texas, United States, 77479
    - Houston Methodist Sugar Land Hospital
- Utah
  - Farmington, Utah, United States, 84025
    - Farmington Health Center
  - Salt Lake City, Utah, United States, 84112
    - Huntsman Cancer Institute/University of Utah
  - Salt Lake City, Utah, United States, 84106
    - University of Utah Sugarhouse Health Center
- Washington
  - Bellevue, Washington, United States, 98004
    - Overlake Medical Center
  - Bremerton, Washington, United States, 98310
    - Harrison HealthPartners Hematology and Oncology-Bremerton
  - Bremerton, Washington, United States, 98310
    - Harrison Medical Center
  - Burien, Washington, United States, 98166
    - Highline Medical Center-Main Campus
  - Enumclaw, Washington, United States, 98022
    - Saint Elizabeth Hospital
  - Federal Way, Washington, United States, 98003
    - Saint Francis Hospital
  - Lakewood, Washington, United States, 98499
    - Saint Clare Hospital
  - Poulsbo, Washington, United States, 98370
    - Harrison HealthPartners Hematology and Oncology-Poulsbo
  - Renton, Washington, United States, 98055
    - Valley Medical Center
  - Tacoma, Washington, United States, 98405
    - Northwest Medical Specialties PLLC
  - Tacoma, Washington, United States, 98405
    - Franciscan Research Center-Northwest Medical Plaza
- Wisconsin
  - Burlington, Wisconsin, United States, 53105
    - Aurora Cancer Care-Southern Lakes VLCC
  - Chippewa Falls, Wisconsin, United States, 54729
    - Marshfield Clinic-Chippewa Center
  - Eau Claire, Wisconsin, United States, 54701
    - Marshfield Medical Center-EC Cancer Center
  - Eau Claire, Wisconsin, United States, 54701
    - Marshfield Clinic Cancer Center at Sacred Heart
  - Fond Du Lac, Wisconsin, United States, 54937
    - Aurora Health Center-Fond du Lac
  - Germantown, Wisconsin, United States, 53022
    - Aurora Health Care Germantown Health Center
  - Grafton, Wisconsin, United States, 53024
    - Aurora Cancer Care-Grafton
  - Green Bay, Wisconsin, United States, 54311
    - Aurora BayCare Medical Center
  - Johnson Creek, Wisconsin, United States, 53038
    - UW Cancer Center Johnson Creek
  - Kenosha, Wisconsin, United States, 53142
    - Aurora Cancer Care-Kenosha South
  - Ladysmith, Wisconsin, United States, 54848
    - Marshfield Clinic - Ladysmith Center
  - Madison, Wisconsin, United States, 53792
    - University of Wisconsin Carbone Cancer Center
  - Marinette, Wisconsin, United States, 54143
    - Aurora Bay Area Medical Group-Marinette
  - Marinette, Wisconsin, United States, 54143
    - Bay Area Medical Center
  - Marshfield, Wisconsin, United States, 54449
    - Marshfield Medical Center-Marshfield
  - Milwaukee, Wisconsin, United States, 53226
    - Medical College of Wisconsin
  - Milwaukee, Wisconsin, United States, 53209
    - Aurora Cancer Care-Milwaukee
  - Milwaukee, Wisconsin, United States, 53215
    - Aurora Saint Luke's Medical Center
  - Milwaukee, Wisconsin, United States, 53233
    - Aurora Sinai Medical Center
  - Minocqua, Wisconsin, United States, 54548
    - Marshfield Clinic-Minocqua Center
  - New Richmond, Wisconsin, United States, 54017
    - Cancer Center of Western Wisconsin
  - Oshkosh, Wisconsin, United States, 54904
    - Vince Lombardi Cancer Clinic - Oshkosh
  - Racine, Wisconsin, United States, 53406
    - Aurora Cancer Care-Racine
  - Rice Lake, Wisconsin, United States, 54868
    - Marshfield Medical Center-Rice Lake
  - Sheboygan, Wisconsin, United States, 53081
    - Vince Lombardi Cancer Clinic-Sheboygan
  - Stevens Point, Wisconsin, United States, 54481
    - Ascension Saint Michael's Hospital
  - Stevens Point, Wisconsin, United States, 54482
    - Marshfield Medical Center-River Region at Stevens Point
  - Summit, Wisconsin, United States, 53066
    - Aurora Medical Center in Summit
  - Two Rivers, Wisconsin, United States, 54241
    - Vince Lombardi Cancer Clinic-Two Rivers
  - Waukesha, Wisconsin, United States, 53188
    - Aurora Cancer Care-Waukesha
  - Wausau, Wisconsin, United States, 54401
    - Marshfield Clinic-Wausau Center
  - Wauwatosa, Wisconsin, United States, 53226
    - Aurora Cancer Care-Milwaukee West
  - West Allis, Wisconsin, United States, 53227
    - Aurora West Allis Medical Center
  - Weston, Wisconsin, United States, 54476
    - Marshfield Medical Center - Weston
  - Wisconsin Rapids, Wisconsin, United States, 54494
    - Marshfield Clinic - Wisconsin Rapids Center
- Wyoming
  - Cody, Wyoming, United States, 82414
    - Big Horn Basin Cancer Center
  - Cody, Wyoming, United States, 82414
    - Billings Clinic-Cody
  - Sheridan, Wyoming, United States, 82801
    - Welch Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Description

Inclusion Criteria:

Patients must have a locally advanced and unresectable or metastatic gastroenteropancreatic neuroendocrine carcinoma that is either known or suspected to be of gastrointestinal (GI) origin; primary tumors arising from the lung, gynecologic organs or prostate are not permitted
Patients must have pathologically/histologically confirmed tumor of non-small cell histology
Patients must have a Ki-67 proliferative index of 20-100% OR at least 10 mitotic figures per 10 high powered fields
Patients must have measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria; baseline measurements and evaluations of all sites of disease must be obtained within 4 weeks prior to randomization and must be acquired by multiphasic computed tomography (CT) or contrast magnetic resonance imaging (MRI)
- NOTE: positron emission tomography (PET)-CT scans are allowed provided the CT portion of the exam is equivalent to a diagnostic CT scan and includes both oral and IV contrast
Patients may not have had any prior systemic treatment for this malignancy (for example chemotherapy or somatostatin analogues); prior palliative radiation is permitted but radiated lesions may not be used for measurement
Patients may not have received any of the protocol agents within 5 years prior to randomization
Any prior surgeries must have been completed at least 4 weeks prior to randomization
Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
Patients may not be receiving any other investigational agents while on study treatment
Patients may not be receiving Coumadin while on treatment; other anticoagulants are allowed
Leukocytes >= 3,000/mm^3
Absolute neutrophil count >= 1,500/mm^3
Hemoglobin >= 9 g/dL
Platelets >= 100,000/mm^3
Total bilirubin =< institutional upper limit of normal (ULN) or =< 1.5 X institutional ULN (if the patient has liver metastases)
Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 X institutional ULN or (=< 5 X institutional ULN if the patient has liver metastases)
Serum creatinine =< 1.5 X institutional ULN and creatinine clearance >= 60 ml/min
- NOTE: creatinine clearance must be calculated using the Cockcroft-Gault equation
Patients must have a life expectancy of >= 12 weeks as determined clinically by the treating physician
Patients with brain metastases (either remote or current) or presence of carcinomatous meningitis are not eligible
Patients with known dihydropyrimidine dehydrogenase (DPD) deficiency will be excluded
Patients must NOT have active or uncontrolled infection, symptomatic heart failure, unstable angina pectoris, cardiac arrhythmia or a serious psychiatric illness/social situation that would limit compliance with study requirements
Patients with impaired decision making capacity may participate in the study if a legal authorized representative is available to consent
Patients must NOT have a history of allergic reactions attributed to compounds of similar chemical or biochemical composition to cisplatin, carboplatin, etoposide, temozolomide or capecitabine
Patients must NOT have absorption issues that would limit the ability to absorb study agents
Patients with a history of the following within =< 12 months of study entry are not eligible:
- Arterial thromboembolic events
- Unstable angina
- Myocardial Infarction
Patients with symptomatic peripheral vascular disease are not eligible
Patients must NOT have previous or concurrent malignancy; exceptions are made for patients who meet any of the following conditions:
- Non-melanoma skin cancer, in situ cervical cancer, superficial bladder cancer, or breast cancer in situ OR
- Prior malignancy completely excised or removed and patient has been continuously disease free for > 5 years OR
- Prior malignancy cured by non-surgical modalities and patient has been continuously disease free for > 5 years
Women must not be pregnant or breast-feeding
- All females of childbearing potential must have a blood test or urine study within 2 weeks prior to randomization to rule out pregnancy
- A female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
Women of childbearing potential and sexually active males must be strongly advised to use an accepted and effective method of contraception or to abstain from sexual intercourse for the duration of their participation in the study
Patients must be able to swallow pills
Patients must be able to tolerate CT or magnetic resonance (MR) imaging including contrast agents as required for the treatment and the protocol
Patients who are known to have human immunodeficiency virus (HIV) or are on combination antiretroviral therapy are ineligible

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm A (capecitabine, temozolomide) Patients receive capecitabine PO BID on days 1-14 and temozolomide PO QD on days 10-14. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Other: Laboratory Biomarker Analysis Correlative studies Drug: Temozolomide Given PO Drug: Capecitabine Given PO
Active Comparator: Arm B (cisplatin, carboplatin, etoposide) Patients receive cisplatin IV on days 1-3 or carboplatin IV on day 1. Patients also receive etoposide IV on days 1-3. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.	Other: Laboratory Biomarker Analysis Correlative studies Drug: Carboplatin Given IV Drug: Etoposide Given IV Drug: Cisplatin Given IV

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PFS Time Frame: Time from randomization to documented progression or death without progression, assessed up to 1 year	Kaplan-Meier estimates will be used for time-to-event distribution. PFS by arm will be compared using one-sided stratified log-rank tests. Stratified Cox?s proportional hazards models will be used to estimate hazard ratios.	Time from randomization to documented progression or death without progression, assessed up to 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of toxicity, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 Time Frame: Up to 30 days after last dose of protocol therapy	90% confidence intervals will be provided.	Up to 30 days after last dose of protocol therapy
OS Time Frame: Time from randomization to death from any cause, assessed up to 5 years	Kaplan-Meier estimates will be used for time-to-event distribution. OS by arm will be compared using one-sided stratified log-rank tests. Stratified Cox?s proportional hazards models will be used to estimate hazard ratios.	Time from randomization to death from any cause, assessed up to 5 years
Response rate (complete response or partial response) by RECIST 1.1 Time Frame: Up to 5 years	Analyzed using a Fisher?s exact test at a one-sided significance level of 0.10.	Up to 5 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ki-67 as a continuous measure assessed by immunohistochemistry (IHC) Time Frame: Baseline	Will evaluate the interaction, if any, between Ki-67 as a continuous measure and treatment. Cox regression of logistic regression, as appropriate, will be used to identify whether the treatment effect varies by Ki-67 for PFS, OS, and RR.	Baseline
Ki-67 measured centrally Time Frame: Baseline	Concordance between Ki-67 measured centrally versus registering institutions? pathology assessments will be investigated and reported. Intra-class correlation will be calculated to assess agreement amongst the two continuous measures.	Baseline
Ki-67 measured with registering institutions? pathology assessments Time Frame: Baseline	Concordance between Ki-67 measured centrally versus registering institutions? pathology assessments will be investigated and reported. Intra-class correlation will be calculated to assess agreement amongst the two continuous measures.	Baseline
Optimal cutoff value in Ki-67 that defines patients with prolonged OS assessed by IHC Time Frame: Baseline	Receiver operating characteristics analysis will be performed to first determine the optimal cutoff value in Ki-67 that defines patients with prolonged OS. For the series of Ki-67 values observed in the data, Youden?s index will be calculated and with the highest index the threshold that minimizes the false positive and false negative rates for best detecting prolonged OS will be identified. Optimal cutoff values of Ki-67 with respect to response to temozolomide and capecitabine, positive octreotide scans, and negative PET scans will also be determined in a similar manner.	Baseline
Prognostic significance of poorly differentiated non-small cell gastroenteropancreatic neuroendocrine tumors Time Frame: Baseline	Will assess the prognostic significance of well differentiated versus poorly differentiated non-small cell gastroenteropancreatic neuroendocrine tumors in relationship to survival and response to treatment in a similar manner, via Cox proportional hazard models for time to event endpoint and logistic regression for objective response.	Baseline
Prognostic significance of well differentiated non-small cell gastroenteropancreatic neuroendocrine tumors Time Frame: Baseline	Will assess the prognostic significance of well differentiated versus poorly differentiated non-small cell gastroenteropancreatic neuroendocrine tumors in relationship to survival and response to treatment in a similar manner, via Cox proportional hazard models for time to event endpoint and logistic regression for objective response.	Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ECOG-ACRIN Cancer Research Group

Collaborators

National Cancer Institute (NCI)

Investigators

Principal Investigator: Jennifer Eads, ECOG-ACRIN Cancer Research Group

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 6, 2016

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

January 1, 2029

Study Registration Dates

First Submitted

November 2, 2015

First Submitted That Met QC Criteria

November 2, 2015

First Posted (Estimated)

November 3, 2015

Study Record Updates

Last Update Posted (Actual)

January 10, 2024

Last Update Submitted That Met QC Criteria

January 8, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

EA2142 (Other Identifier: CTEP)
U10CA180820 (U.S. NIH Grant/Contract)
NCI-2015-00547 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
NCI-2015-00505

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Study Overview

Status

Conditions

Intervention / Treatment

Detailed Description

Study Type

Enrollment (Actual)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Other Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Collaborators

Investigators

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Estimated)

Study Completion (Estimated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Estimated)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

Clinical Trials on Gastric Neuroendocrine Carcinoma

Clinical Trials on Laboratory Biomarker Analysis

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Sponsors and Collaborators

Medical Conditions

Drug Interventions

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CROs in Uruguay

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations