Temozolomide With or Without Capecitabine in Treating Patients With Advanced Pancreatic Neuroendocrine Tumors

February 4, 2024 updated by: ECOG-ACRIN Cancer Research Group

A Randomized Phase II Study of Temozolomide or Temozolomide and Capecitabine in Patients With Advanced Pancreatic Neuroendocrine Tumors

This randomized phase II trial studies how well giving temozolomide with or without capecitabine works in treating patients with advanced pancreatic neuroendocrine tumors. Drugs used in chemotherapy, such as temozolomide and capecitabine, 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. It is not yet known whether temozolomide is more effective with or without capecitabine in treating patients with advanced pancreatic neuroendocrine tumors.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVES:

I. To evaluate progression-free survival (PFS) associated with temozolomide alone or temozolomide and capecitabine in patients with advanced pancreatic neuroendocrine tumors.

SECONDARY OBJECTIVES:

I. To evaluate response rates (RR) associated with temozolomide alone or temozolomide and capecitabine treatment in patients with advanced pancreatic neuroendocrine tumors.

II. To evaluate overall survival (OS) associated with temozolomide alone or temozolomide and capecitabine in patients with advanced pancreatic neuroendocrine tumors.

III. To evaluate the toxicity associated with temozolomide alone or temozolomide and capecitabine treatment in patients with advanced pancreatic neuroendocrine tumors.

IV. To evaluate the usefulness of methyl guanine methyltransferase (MGMT) status (by immunohistochemistry [IHC] and promoter methylation) for predicting response in pancreatic neuroendocrine tumor patients treated with either temozolomide or temozolomide and capecitabine.

V. To bank radiology images for evaluation of quality, reproducibility, and compliance with computed tomography (CT) methodology.

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

ARM A: Patients receive temozolomide orally (PO) once daily (QD) on days 1-5. Treatment repeats every 28 days for up to 13 courses in the absence of disease progression or unacceptable toxicity.

ARM B: Patients receive capecitabine PO twice daily (BID) on days 1-14 and temozolomide PO QD on days 10-14. Treatment repeats every 28 days for up to 13 courses 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)

144

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
- California
  - Anaheim, California, United States, 92807
    - Kaiser Anaheim Medical Center
  - Antioch, California, United States, 94531
    - Kaiser Permanente-Deer Valley Medical Center
  - Baldwin Park, California, United States, 91706
    - Kaiser Permanente Medical Group - Baldwin Park
  - Bellflower, California, United States, 90706
    - Kaiser Foundation Hospital
  - Berkeley, California, United States, 94704
    - Alta Bates Summit Medical Center-Herrick Campus
  - Burlingame, California, United States, 94010
    - Mills - Peninsula Hospitals
  - Fontana, California, United States, 92335
    - Kaiser Permanente Hospital
  - Fremont, California, United States, 94538
    - Kaiser Permanente, Fremont
  - Fresno, California, United States, 93720
    - Kaiser Permanente
  - Harbor City, California, United States, 90710
    - Kaiser Permanente - Harbor City
  - Hayward, California, United States, 94545
    - Kaiser Permanente, Hayward
  - Irvine, California, United States, 92618
    - Southern California Permanente Medical Group
  - Los Angeles, California, United States, 90048
    - Cedars-Sinai Medical Center
  - Los Angeles, California, United States, 90027
    - Kaiser Permanente Los Angeles Medical Center
  - Los Angeles, California, United States, 90033
    - University of Southern California/Norris Cancer Center
  - Los Angeles, California, United States, 90034
    - Kaiser Permanente-West Los Angeles
  - Modesto, California, United States, 95356
    - Kaiser Permanente-Modesto
  - Novato, California, United States, 94945
    - Sutter Cancer Research Consortium
  - Oakland, California, United States, 94611
    - Kaiser Permanente-Oakland
  - Orange, California, United States, 92868
    - University of California Medical Center At Irvine-Orange Campus
  - Panorama City, California, United States, 91402
    - Kaiser Permanente - Panorama City
  - Redwood City, California, United States, 94063
    - Kaiser Permanente-Redwood City
  - Richmond, California, United States, 94801
    - Kaiser Permanente-Richmond
  - Riverside, California, United States, 92505
    - Kaiser Permanente Medical Center
  - Roseville, California, United States, 95661
    - Kaiser Permanente-Roseville
  - Sacramento, California, United States, 95823
    - Kaiser Permanente-South Sacramento
  - Sacramento, California, United States, 95825
    - Kaiser Permanente - Sacramento
  - San Diego, California, United States, 92120
    - Kaiser Permanente at San Diego
  - San Diego, California, United States, 92120
    - Kaiser Permanente
  - San Francisco, California, United States, 94115
    - Kaiser Permanente-San Francisco
  - San Francisco, California, United States, 94118
    - California Pacific Medical Center
  - San Francisco, California, United States, 94115
    - UCSF-Mount Zion
  - San Jose, California, United States, 95119
    - Kaiser Permanente-Santa Teresa-San Jose
  - San Marcos, California, United States, 92069
    - Kaiser Permanente Health Care
  - San Rafael, California, United States, 94903
    - Kaiser Permanente-San Rafael
  - Santa Clara, California, United States, 95051
    - Kaiser Permanente Medical Center - Santa Clara
  - 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
  - Stanford, California, United States, 94305
    - Stanford University Hospitals and Clinics
  - Stockton, California, United States, 95210
    - Kaiser Permanente-Stockton
  - Vacaville, California, United States, 95688
    - Kaiser Permanente Medical Center-Vacaville
  - Vallejo, California, United States, 94589
    - Kaiser Permanente-Vallejo
  - Vallejo, California, United States, 94589
    - Sutter Solano Medical Center
  - Walnut Creek, California, United States, 94596
    - Kaiser Permanente-Walnut Creek
  - Woodland Hills, California, United States, 91367
    - Kaiser Permanente
- Connecticut
  - Hartford, Connecticut, United States, 06105
    - Saint Francis Hospital and Medical Center
  - Middletown, Connecticut, United States, 06457
    - Middlesex Hospital
- Delaware
  - 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
  - Newark, Delaware, United States, 19713
    - Regional Hematology and Oncology PA
  - Rehoboth Beach, Delaware, United States, 19971
    - Beebe Health Campus
  - Seaford, Delaware, United States, 19973
    - Nanticoke Memorial Hospital
  - Wilmington, Delaware, United States, 19801
    - Christiana Care Health System-Wilmington Hospital
- Florida
  - Jacksonville, Florida, United States, 32207
    - Edna Williams Cancer Center at the Baptist Cancer Institute
  - Miami, Florida, United States, 33136
    - University of Miami Miller School of Medicine-Sylvester Cancer Center
  - Orlando, Florida, United States, 32803
    - Florida Hospital
  - Tampa, Florida, United States, 33612
    - H. Lee Moffitt Cancer Center and Research Institute
- Hawaii
  - 'Aiea, Hawaii, United States, 96701
    - Pali Momi Medical Center
  - 'Aiea, Hawaii, United States, 96701
    - Oncare Hawaii Inc-Pali Momi
  - Honolulu, Hawaii, United States, 96813
    - Queen's Medical Center
  - Honolulu, Hawaii, United States, 96813
    - Straub Clinic and Hospital
  - Honolulu, Hawaii, United States, 96819
    - Kaiser Permanente Moanalua Medical Center
  - Honolulu, Hawaii, United States, 96813
    - University of Hawaii
  - Honolulu, Hawaii, United States, 96813
    - Oncare Hawaii Inc-POB II
  - Honolulu, Hawaii, United States, 96817-3169
    - OnCare Hawaii-Liliha
  - Honolulu, Hawaii, United States, 96817
    - Oncare Hawaii Inc-Kuakini
  - Kailua, Hawaii, United States, 96734
    - Castle Medical Center
  - Lihue, Hawaii, United States, 96766
    - Wilcox Memorial Hospital and Kauai Medical Clinic
- Idaho
  - Boise, Idaho, United States, 83706
    - Saint Alphonsus Regional Medical Center
- Illinois
  - Bloomington, Illinois, United States, 61701
    - Saint Joseph Medical Center
  - Bloomington, Illinois, United States, 61701
    - Illinois CancerCare-Bloomington
  - Canton, Illinois, United States, 61520
    - Illinois CancerCare-Canton
  - Carbondale, Illinois, United States, 62902
    - Memorial Hospital of Carbondale
  - 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
    - University of Illinois
  - Decatur, Illinois, United States, 62526
    - Decatur Memorial Hospital
  - Decatur, Illinois, United States, 62526
    - Cancer Care Center of Decatur
  - Effingham, Illinois, United States, 62401
    - Crossroads Cancer Center
  - Eureka, Illinois, United States, 61530
    - Illinois CancerCare-Eureka
  - Galesburg, Illinois, United States, 61401
    - Illinois CancerCare Galesburg
  - Galesburg, Illinois, United States, 61401
    - Illinois CancerCare-Galesburg Cottage Plaza Office
  - Highland Park, Illinois, United States, 60035
    - Hematology Oncology Associates of Illinois-Highland Park
  - Hinsdale, Illinois, United States, 60521
    - Hinsdale Hematology Oncology Associates Incorporated
  - Kankakee, Illinois, United States, 60901
    - Presence Saint Mary's Hospital
  - Kewanee, Illinois, United States, 61443
    - Illinois CancerCare-Kewanee Clinic
  - Libertyville, Illinois, United States, 60048
    - North Shore Hematology Oncology
  - Macomb, Illinois, United States, 61455
    - Illinois CancerCare-Macomb
  - Maywood, Illinois, United States, 60153
    - Loyola University Medical Center
  - Moline, Illinois, United States, 61265
    - Garneau, Stewart C MD (UIA Investigator)
  - Moline, Illinois, United States, 61265
    - Porubcin, Michael MD (UIA Investigator)
  - Moline, Illinois, United States, 61265
    - Spector, David MD (UIA Investigator)
  - Moline, Illinois, United States, 61265
    - Trinity Medical Center
  - Monmouth, Illinois, United States, 61462
    - Illinois CancerCare-Monmouth
  - Mount Vernon, Illinois, United States, 62864
    - Good Samaritan Regional Health Center
  - Niles, Illinois, United States, 60714
    - Illinois Cancer Specialists-Niles
  - Normal, Illinois, United States, 61761
    - Community Cancer Center Foundation
  - Ottawa, Illinois, United States, 61350
    - Illinois CancerCare-Ottawa Clinic
  - Ottawa, Illinois, United States, 61350
    - Ottawa Regional Hospital and Healthcare Center
  - Pekin, Illinois, United States, 61554
    - Pekin Cancer Treatment Center
  - Pekin, Illinois, United States, 61603
    - Illinois CancerCare-Pekin
  - Peoria, Illinois, United States, 61637
    - OSF Saint Francis Medical Center
  - Peoria, Illinois, United States, 61615
    - Illinois CancerCare-Peoria
  - Peoria, Illinois, United States, 61614
    - Proctor Hospital
  - Peoria, Illinois, United States, 61603
    - Methodist Medical Center of Illinois
  - Peoria, Illinois, United States, 61615
    - Illinois Oncology Research Association CCOP
  - Peru, Illinois, United States, 61354
    - Illinois CancerCare-Peru
  - Princeton, Illinois, United States, 61356
    - Illinois CancerCare-Princeton
  - Rockford, Illinois, United States, 61107
    - SwedishAmerican Regional Cancer Center/ACT
  - Skokie, Illinois, United States, 60076
    - Hematology Oncology Associates of Illinois - Skokie
  - Springfield, Illinois, United States, 62781-0001
    - Memorial Medical Center
- Indiana
  - Indianapolis, Indiana, United States, 46237
    - Franciscan Saint Francis Health-Indianapolis
  - Richmond, Indiana, United States, 47374
    - Reid Hospital and Health Care Services
- Iowa
  - Ames, Iowa, United States, 50010
    - Mary Greeley Medical Center
  - Ames, Iowa, United States, 50010
    - McFarland Clinic PC-William R Bliss Cancer Center
  - Bettendorf, Iowa, United States, 52722
    - Constantinou, Costas L MD (UIA Investigator)
  - 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
  - Des Moines, Iowa, United States, 50309
    - Iowa Methodist Medical Center
  - Des Moines, Iowa, United States, 50314
    - Mercy Medical Center - Des Moines
  - Des Moines, Iowa, United States, 50309
    - Medical Oncology and Hematology Associates-Des Moines
  - Des Moines, Iowa, United States, 50316
    - Iowa Lutheran Hospital
  - Des Moines, Iowa, United States, 50314
    - Medical Oncology and Hematology Associates-Laurel
  - Des Moines, Iowa, United States, 50309
    - Iowa Oncology Research Association CCOP
  - Jefferson, Iowa, United States, 50129
    - McFarland Clinic PC-Jefferson
  - Marshalltown, Iowa, United States, 50158
    - McFarland Clinic PC-Marshalltown
  - Sioux City, Iowa, United States, 51104
    - Saint Luke's Regional Medical Center
  - Sioux City, Iowa, United States, 51101
    - Siouxland Hematology Oncology Associates
  - Sioux City, Iowa, United States, 51104
    - Mercy Medical Center-Sioux City
  - West Des Moines, Iowa, United States, 50266-7700
    - Methodist West Hospital
  - West Des Moines, Iowa, United States, 50266
    - Mercy Medical Center-West Lakes
- Kansas
  - Chanute, Kansas, United States, 66720
    - Cancer Center of Kansas - Chanute
  - 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
  - Independence, Kansas, United States, 67301
    - Cancer Center of Kansas-Independence
  - Kingman, Kansas, United States, 67068
    - Cancer Center of Kansas-Kingman
  - Lawrence, Kansas, United States, 66044
    - Lawrence Memorial Hospital
  - Liberal, Kansas, United States, 67901
    - 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
  - Parsons, Kansas, United States, 67357
    - Cancer Center of Kansas - Parsons
  - Pratt, Kansas, United States, 67124
    - Cancer Center of Kansas - Pratt
  - Salina, Kansas, United States, 67401
    - Cancer Center of Kansas - Salina
  - Wellington, Kansas, United States, 67152
    - Cancer Center of Kansas - Wellington
  - Wichita, Kansas, United States, 67208
    - Cancer Center of Kansas-Wichita Medical Arts Tower
  - Wichita, Kansas, United States, 67208
    - Associates In Womens Health
  - Wichita, Kansas, United States, 67214
    - Cancer Center of Kansas - Main Office
  - Wichita, Kansas, United States, 67214
    - Via Christi Regional Medical Center
  - Wichita, Kansas, United States, 67214
    - Wichita CCOP
  - Winfield, Kansas, United States, 67156
    - Cancer Center of Kansas - Winfield
- Kentucky
  - Crestview Hills, Kentucky, United States, 41017
    - Oncology Hematology Care Incorporated
- Louisiana
  - Baton Rouge, Louisiana, United States, 70809
    - Ochsner Health Center-Summa
  - New Orleans, Louisiana, United States, 70121
    - Ochsner Medical Center Jefferson
- Massachusetts
  - Boston, Massachusetts, United States, 02118
    - Boston Medical Center
  - Burlington, Massachusetts, United States, 01805
    - Lahey Hospital and Medical Center
- Michigan
  - Adrian, Michigan, United States, 49221
    - Bixby Medical Center
  - Adrian, Michigan, United States, 49221
    - Hickman Cancer Center
  - Ann Arbor, Michigan, United States, 48106-0995
    - Saint Joseph Mercy Hospital
  - Ann Arbor, Michigan, United States, 48106
    - Michigan Cancer Research Consortium Community Clinical Oncology Program
  - Ann Arbor, Michigan, United States, 48109
    - University of Michigan University Hospital
  - Dearborn, Michigan, United States, 48124
    - Oakwood Hospital
  - Detroit, Michigan, United States, 48236
    - Saint John Hospital and Medical Center
  - Flint, Michigan, United States, 48502
    - Hurley Medical Center
  - Flint, Michigan, United States, 48503
    - Genesys Hurley Cancer Institute
  - 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, 49001
    - Borgess Medical Center
  - Lansing, Michigan, United States, 48912
    - Sparrow Hospital
  - Livonia, Michigan, United States, 48154
    - Saint Mary Mercy Hospital
  - Monroe, Michigan, United States, 48162
    - Mercy Memorial Hospital
  - Monroe, Michigan, United States, 48162
    - Community Cancer Center of Monroe
  - Pontiac, Michigan, United States, 48341-2985
    - Saint Joseph Mercy Oakland
  - Port Huron, Michigan, United States, 48060
    - Saint Joseph Mercy Port Huron
  - Saginaw, Michigan, United States, 48601
    - Saint Mary's of Michigan
  - Warren, Michigan, United States, 48093
    - Saint John Macomb-Oakland Hospital
- Minnesota
  - Burnsville, Minnesota, United States, 55337
    - Fairview Ridges Hospital
  - Coon Rapids, Minnesota, United States, 55433
    - Mercy Hospital
  - Edina, Minnesota, United States, 55435
    - Fairview-Southdale Hospital
  - Fridley, Minnesota, United States, 55432
    - Unity Hospital
  - Hutchinson, Minnesota, United States, 55350
    - Hutchinson Area Health Care
  - 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
  - New Ulm, Minnesota, United States, 56073
    - New Ulm Medical Center
  - Robbinsdale, Minnesota, United States, 55422
    - North Memorial Medical Health Center
  - Saint Louis Park, Minnesota, United States, 55416
    - Park Nicollet Clinic - Saint Louis Park
  - Saint Louis Park, Minnesota, United States, 55416
    - Metro-Minnesota CCOP
  - 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
  - Waconia, Minnesota, United States, 55387
    - Ridgeview Medical Center
  - Willmar, Minnesota, United States, 56201
    - Rice Memorial Hospital
  - Woodbury, Minnesota, United States, 55125
    - Minnesota Oncology and Hematology PA-Woodbury
- Missouri
  - Bolivar, Missouri, United States, 65613
    - Central Care Cancer Center-Carrie J Babb Cancer Center
  - Branson, Missouri, United States, 65616
    - CoxHealth Cancer Center
  - Cape Girardeau, Missouri, United States, 63703
    - Saint Francis Medical Center
  - Cape Girardeau, Missouri, United States, 63703
    - Southeast Cancer Center
  - Jefferson City, Missouri, United States, 65109
    - Capital Region Medical Center-Goldschmidt Cancer Center
  - Rolla, Missouri, United States, 65401
    - Phelps County Regional Medical Center
  - Rolla, Missouri, United States, 65401
    - Saint John's Clinic-Rolla-Cancer and Hematology
  - Saint Louis, Missouri, United States, 63131
    - Missouri Baptist Medical Center
  - Saint Louis, Missouri, United States, 63109
    - Saint Louis Cancer and Breast Institute-South City
  - Saint Louis, Missouri, United States, 63141
    - Saint John's Mercy Medical Center
  - Springfield, Missouri, United States, 65807
    - CoxHealth South Hospital
  - Springfield, Missouri, United States, 65804
    - Mercy Hospital Springfield
  - Springfield, Missouri, United States, 65802
    - Ozark Health Ventures LLC dba Cancer Research for The Ozarks Springfield
- Nebraska
  - Omaha, Nebraska, United States, 68114
    - Nebraska Methodist Hospital
- Nevada
  - Las Vegas, Nevada, United States, 89106
    - Nevada Cancer Research Foundation CCOP
- New Jersey
  - Camden, New Jersey, United States, 08103
    - Cooper Hospital University Medical Center
  - Mount Holly, New Jersey, United States, 08060
    - Fox Chase Cancer Center at Virtua Memorial Hospital of Burlington County
  - Voorhees, New Jersey, United States, 08043
    - Virtua West Jersey Hospital Voorhees
- New York
  - Albany, New York, United States, 12208
    - New York Oncology Hematology PC -Albany Medical Center
  - Albany, New York, United States, 12206
    - New York Oncology Hematology PC - Albany
  - Amsterdam, New York, United States, 12010
    - New York Oncology Hematology PC - Amsterdam
  - Bronx, New York, United States, 10467-2490
    - Montefiore Medical Center
  - Bronx, New York, United States, 10461
    - Montefiore Medical Center-Weiler Division
  - Hudson, New York, United States, 12534
    - New York Oncology Hematology PC-Hudson
  - Latham, New York, United States, 12110
    - New York Oncology Hematology PC - Latham
  - Rexford, New York, United States, 12148
    - New York Oncology Hematology PC - Rexford
  - Rochester, New York, United States, 14642
    - University of Rochester
  - Troy, New York, United States, 12180
    - New York Oncology Hematology PC - Troy
- North Carolina
  - Kinston, North Carolina, United States, 28501
    - Kinston Medical Specialists PA
  - Statesville, North Carolina, United States, 28677
    - Iredell Memorial Hospital
- Ohio
  - Akron, Ohio, United States, 44307
    - Akron General Medical Center
  - Beachwood, Ohio, United States, 44122
    - Cleveland Clinic Cancer Center Beachwood
  - Belpre, Ohio, United States, 45714
    - Strecker Cancer Center-Belpre
  - Bowling Green, Ohio, United States, 43402
    - Toledo Clinic Cancer Centers-Bowling Green
  - Chillicothe, Ohio, United States, 45601
    - Adena Regional Medical Center
  - Cincinnati, Ohio, United States, 45267
    - University of Cincinnati
  - Cincinnati, Ohio, United States, 45230
    - Oncology Hematology Care Inc - Anderson
  - Cincinnati, Ohio, United States, 45236
    - Oncology Hematology Care Inc - Kenwood
  - Cincinnati, Ohio, United States, 45219
    - Oncology and Hematology Care Incorporated
  - Cincinnati, Ohio, United States, 45242
    - Oncology and Hematology Care Inc - Blue Ash
  - Cincinnati, Ohio, United States, 45248
    - Oncology Hematology Care Inc - Western Hills
  - Cleveland, Ohio, United States, 44106
    - Case Western Reserve University
  - Cleveland, Ohio, United States, 44195
    - Cleveland Clinic Foundation
  - Columbus, Ohio, United States, 43214
    - Riverside Methodist Hospital
  - Columbus, Ohio, United States, 43219
    - The Mark H Zangmeister Center
  - Columbus, Ohio, United States, 43210
    - Ohio State University Medical Center
  - Columbus, Ohio, United States, 43214
    - Columbus Oncology and Hematology Associates Inc
  - Columbus, Ohio, United States, 43228
    - Doctors Hospital
  - Columbus, Ohio, United States, 43215
    - Grant Medical Center
  - Columbus, Ohio, United States, 43222
    - Mount Carmel Health Center West
  - Columbus, Ohio, United States, 43215
    - Columbus CCOP
  - Dayton, Ohio, United States, 45406
    - Good Samaritan Hospital - Dayton
  - Dayton, Ohio, United States, 45409
    - Miami Valley Hospital
  - Dayton, Ohio, United States, 45415
    - Samaritan North Health Center
  - Dayton, Ohio, United States, 45405
    - Grandview Hospital
  - Dayton, Ohio, United States, 45420
    - Dayton CCOP
  - 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
  - Elyria, Ohio, United States, 44035
    - Mercy Cancer Center-Elyria
  - Elyria, Ohio, United States, 44035
    - Hematology Oncology Center Incorporated
  - Fairfield, Ohio, United States, 45014
    - Oncology Hematology Care Inc
  - Findlay, Ohio, United States, 45840
    - Blanchard Valley Hospital
  - Franklin, Ohio, United States, 45005-1066
    - Atrium Medical Center-Middletown Regional Hospital
  - Greenville, Ohio, United States, 45331
    - Wayne Hospital
  - Independence, Ohio, United States, 44131
    - Cleveland Clinic Cancer Center Independence
  - Kettering, Ohio, United States, 45429
    - Kettering Medical Center
  - Lancaster, Ohio, United States, 43130
    - Fairfield Medical Center
  - Lancaster, Ohio, United States, 43130
    - Lancaster Radiation Oncology
  - Lima, Ohio, United States, 45801
    - Saint Rita's Medical Center
  - Lima, Ohio, United States, 45804
    - Lima Memorial Hospital
  - Marietta, Ohio, United States, 45750
    - Marietta Memorial Hospital
  - Maumee, Ohio, United States, 43537
    - Toledo Clinic Cancer Centers-Maumee
  - Maumee, Ohio, United States, 43537
    - Toledo Radiation Oncology at Northwest Ohio Onocolgy Center
  - Mayfield Heights, Ohio, United States, 44124
    - Hillcrest Hospital Cancer Center
  - 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
  - Oregon, Ohio, United States, 43616
    - Saint Charles Hospital
  - Oregon, Ohio, United States, 43616
    - Toledo Clinic Cancer Centers-Oregon
  - Portsmouth, Ohio, United States, 45662
    - Southern Ohio Medical Center
  - Sandusky, Ohio, United States, 44870
    - North Coast Cancer Care
  - Springfield, Ohio, United States, 45505
    - Springfield Regional Medical Center
  - Strongsville, Ohio, United States, 44136
    - Cleveland Clinic Cancer Center-Strongsville
  - Sylvania, Ohio, United States, 43560
    - Flower Hospital
  - Tiffin, Ohio, United States, 44883
    - Mercy Hospital of Tiffin
  - Toledo, Ohio, United States, 43608
    - Saint Vincent Mercy Medical Center
  - Toledo, Ohio, United States, 43623
    - Toledo Clinic Cancer Centers-Toledo
  - Toledo, Ohio, United States, 43614
    - University of Toledo
  - Toledo, Ohio, United States, 43617
    - Toledo Community Hospital Oncology Program CCOP
  - Toledo, Ohio, United States, 43606
    - The Toledo Hospital/Toledo Children's Hospital
  - Toledo, Ohio, United States, 43623
    - Mercy Saint Anne Hospital
  - Troy, Ohio, United States, 45373
    - Upper Valley Medical Center
  - Wauseon, Ohio, United States, 43567
    - Fulton County Health Center
  - Westerville, Ohio, United States, 43081
    - Saint Ann's Hospital
  - Xenia, Ohio, United States, 45385
    - Greene Memorial Hospital
  - Zanesville, Ohio, United States, 43701
    - Genesis Healthcare System
- Oklahoma
  - Oklahoma City, Oklahoma, United States, 73104
    - University of Oklahoma Health Sciences Center
  - Tulsa, Oklahoma, United States, 74146
    - Tulsa Cancer Institute
- Pennsylvania
  - Danville, Pennsylvania, United States, 17822-2001
    - Geisinger Medical Center
  - Hazleton, Pennsylvania, United States, 18201
    - Geisinger Medical Center-Cancer Center Hazleton
  - Hershey, Pennsylvania, United States, 17033-0850
    - Penn State Milton S Hershey Medical Center
  - Lewisburg, Pennsylvania, United States, 17837
    - Geisinger Medical Oncology at Evangelical Community Hospital
  - Philadelphia, Pennsylvania, United States, 19111
    - Fox Chase Cancer Center
  - Philadelphia, Pennsylvania, United States, 19107
    - Thomas Jefferson University Hospital
  - Pottsville, Pennsylvania, United States, 17901
    - Geisinger Medical Oncology-Pottsville
  - State College, Pennsylvania, United States, 16801
    - Geisinger Medical Group
  - West Reading, Pennsylvania, United States, 19611
    - Reading Hospital
  - Wilkes-Barre, Pennsylvania, United States, 18711
    - Geisinger Wyoming Valley
- South Carolina
  - Greenville, South Carolina, United States, 29605
    - Greenville Health System Cancer Institute-Butternut
  - Greenville, South Carolina, United States, 29615
    - Greenville Health System Cancer Institute/Greenville CCOP
  - Greer, South Carolina, United States, 29650
    - Greenville Health System Cancer Institute-Greer
- Tennessee
  - Nashville, Tennessee, United States, 37232-6838
    - Vanderbilt Cancer Center
- Virginia
  - Fredericksburg, Virginia, United States, 22401
    - Fredericksburg Oncology Inc
- Wisconsin
  - La Crosse, Wisconsin, United States, 54601
    - Gundersen Lutheran
  - Madison, Wisconsin, United States, 53792
    - University of Wisconsin Hospital and Clinics
  - Milwaukee, Wisconsin, United States, 53226
    - Froedtert and The Medical College of Wisconsin
  - New Richmond, Wisconsin, United States, 54017
    - Cancer Center of Western Wisconsin

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:

Patient must have histologically or pathologically confirmed locally unresectable or metastatic low or intermediate grade pancreatic neuroendocrine tumor
Patient 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 <= 4 weeks prior to randomization and must be acquired by multiphasic CT or contrast magnetic resonance imaging (MRI)
Date of last documented disease progression must be within 12 months from date of randomization
Prior everolimus and/or sunitinib therapy is allowed, so long as it was discontinued >= 4 weeks prior to randomization
Concurrent somatostatin analogues are allowed provided that patients
- Have been on a stable dose for 8 weeks and
- Have documented disease progression on that dose
Chemoembolization is allowed if ≥ 4 weeks from study entry. There are 2 possible scenarios:
- If patient has hepatic disease only: they need to have progressed in the liver since chemoembolization and have measurable disease by RECIST 1.1 in order to be eligible.
- If patient has hepatic and extrahepatic disease: they will need to have progressed inside OR outside the liver and have measureable disease by RECIST 1.1 in order to be eligible.
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]) <= 3 X institutional ULN or (<= 5 X institutional ULN if the patient has liver metastases)
Serum creatinine <= 1.5 X institutional ULN
Patient must have Eastern Cooperative Oncology Group (ECOG) performance status 0-1
Patient must have life expectancy >= 12 weeks 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:
- Has not undergone a hysterectomy or bilateral oophorectomy; or
- 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; should a woman become pregnant while participating in this study, she should inform her treating physician immediately; if a man impregnates a woman while participating in this study, he should inform his treating physician immediately
Patient must be able to swallow pills
Patient must be able to tolerate CT or magnetic resonance (MR) imaging including contrast agents as required for their treatment and the protocol

Exclusion Criteria:

Small cell carcinoma
Prior temozolomide, dacarbazine (DTIC), or capecitabine, or 5-FU (fluorouracil) therapy
Receiving any other investigational agents while on study treatment
Receiving Coumadin while on treatment; other anticoagulants are allowed
Patients with either clinically apparent central nervous system metastases or carcinomatous meningitis are ineligible
Active or uncontrolled infection or serious medical or psychiatric illness
History of allergic reactions attributed to compounds of similar chemical or biologic composition to temozolomide or capecitabine
Absorption issues that would limit the ability to absorb study agents
Patients with a history of the following within 12 months of study entry:
- Arterial thromboembolic events
- Unstable angina
- Myocardial Infarction
Symptomatic peripheral vascular disease
Patients with previous or concurrent malignancy; exceptions are made for patients who meet any of the following conditions:
- Non-melanoma skin cancer, in situ cervical 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
Pregnant or breast-feeding

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 (temozolomide) Patients receive temozolomide PO QD on days 1-5. Treatment repeats every 28 days for up to 13 courses in the absence of disease progression or unacceptable toxicity.	Drug: temozolomide Given PO Other Names: Temodar
Experimental: Arm B (temozolomide and capecitabine) Patients receive capecitabine PO BID on days 1-14 and temozolomide PO QD on days 10-14. Treatment repeats every 28 days for up to 13 courses in the absence of disease progression or unacceptable toxicity.	Drug: capecitabine Given PO Other Names: Xeloda Drug: temozolomide Given PO Other Names: Temodar

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free Survival Time Frame: Assessed every 3 months for 3 years and then every 6 months for years 3-5	Progression-free survival (PFS) is defined as the time from randomization to progression or death without evidence of progression. Progression was evaluated using the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1) and defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Kaplan-Meier method was used to estimate PFS.	Assessed every 3 months for 3 years and then every 6 months for years 3-5

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Patients With Response Time Frame: Assessed every 3 months for 3 years and then every 6 months for years 3-5	Response was evaluated using the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1) and defined as either complete response (CR) or partial response (PR). CR is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.	Assessed every 3 months for 3 years and then every 6 months for years 3-5
Overall Survival Time Frame: Assessed every 3 months for 3 years and then every 6 months for years 3-5	Overall survival is defined as time from randomization to death or date last known alive.	Assessed every 3 months for 3 years and then every 6 months for years 3-5
Association Between Methyl Guanine Methyltransferase (MGMT) Status by Immunohistochemistry (IHC) and Response Time Frame: Assessed every 3 months for 3 years and then every 6 months for years 3-5	Response was evaluated using the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1) and defined as either complete response (CR) or partial response (PR). CR is defined as disappearance of all target lesions. PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. MGMT status was determined by IHC using paraffin-embedded sections of 4µm. A score (H-score) was generated based on the findings and scoring was performed by two pathologists. This H-score ranges from 0 (no staining in the tumor) to 300 (diffuse intense staining of the tumor). The highest score was used if there was disagreement. H-scores were grouped into 3 standard categories for MGMT status: Category 1 - <=50 Category 2 - 51-100 Category 3 - >100	Assessed every 3 months for 3 years and then every 6 months for years 3-5
Association Between Methyl Guanine Methyltransferase (MGMT) Status by Promoter Methylation and Response Time Frame: Assessed every 3 months for 3 years and then every 6 months for years 3-5	Response was evaluated using the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1) and defined as either complete response (CR) or partial response (PR). CR is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. MGMT status is determined by promoter methylation, a clinically validated methylation-specific polymerase chain reaction (PCR) analysis. A tumor sample is considered positive for MGMT promoter methylation if an 80bp band is detected in the methylated PCR reaction. It would be considered MGMT negative if an 80bp band is not detected in the methylated PCR reaction.	Assessed every 3 months for 3 years and then every 6 months for years 3-5

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: Pamela Kunz, ECOG-ACRIN Cancer Research Group

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Kunz PL, Graham NT, Catalano PJ, Nimeiri HS, Fisher GA, Longacre TA, Suarez CJ, Martin BA, Yao JC, Kulke MH, Hendifar AE, Shanks JC, Shah MH, Zalupski MM, Schmulbach EL, Reidy-Lagunes DL, Strosberg JR, O'Dwyer PJ, Benson AB 3rd. Randomized Study of Temozolomide or Temozolomide and Capecitabine in Patients With Advanced Pancreatic Neuroendocrine Tumors (ECOG-ACRIN E2211). J Clin Oncol. 2023 Mar 1;41(7):1359-1369. doi: 10.1200/JCO.22.01013. Epub 2022 Oct 19.

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)

August 8, 2013

Primary Completion (Actual)

May 26, 2021

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

April 2, 2013

First Submitted That Met QC Criteria

April 2, 2013

First Posted (Estimated)

April 5, 2013

Study Record Updates

Last Update Posted (Estimated)

February 7, 2024

Last Update Submitted That Met QC Criteria

February 4, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

E2211 (Other Identifier: ECOG-ACRIN Cancer Research Group)
U10CA180820 (U.S. NIH Grant/Contract)
U10CA021115 (U.S. NIH Grant/Contract)
NCI-2012-02007 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data may be made available upon request as per the ECOG-ACRIN Data Sharing Policy.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

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

Collaborators and Investigators

Sponsor

Collaborators

Investigators

Publications and helpful links

General Publications

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Actual)

Study Completion (Estimated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Estimated)

Study Record Updates

Last Update Posted (Estimated)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

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Clinical Trials on capecitabine

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