Paclitaxel and Cisplatin or Topotecan With or Without Bevacizumab in Treating Patients With Stage IVB, Recurrent, or Persistent Cervical Cancer

July 19, 2019 updated by: National Cancer Institute (NCI)

A Randomized Phase III Trial of Cisplatin Plus Paclitaxel With and Without NCI-Supplied Bevacizumab (NSC #704865) Versus the Non-platinum Doublet, Topotecan Plus Paclitaxel, With and Without NCI-Supplied Bevacizumab, in Stage IVB, Recurrent or Persistent Carcinoma of the Cervix

This randomized phase III trial studies the side effects of paclitaxel when given together with cisplatin or topotecan with or without bevacizumab and to compare how well they work in treating patients with stage IVB, cervical cancer that has come back or is persistent. Drugs used in chemotherapy, such as paclitaxel, cisplatin, and topotecan, 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. Monoclonal antibodies, such as bevacizumab, may interfere with the ability of tumor cells to grow and spread. It is not yet known whether paclitaxel is more effective when given together with cisplatin or topotecan with or without bevacizumab in treating patients with cervical cancer.

Study Overview

Detailed Description

PRIMARY OBJECTIVES:

I. To determine whether the addition of bevacizumab to chemotherapy improves overall survival. Also to determine if a regimen involving paclitaxel and topotecan improves overall survival in comparison to a regimen involving cisplatin and paclitaxel. These regimens are to be evaluated in patients with stage IVB, recurrent, or persistent carcinoma of the cervix.

II. To determine and compare the frequency and severity of adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 for the regimens administered on this study.

SECONDARY OBJECTIVES:

I. To estimate and compare the progression-free survival of patients treated by the regimens investigated on this study.

II. To estimate and compare the proportion of patients with tumor responses by the regimens investigated on this study.

TERTIARY OBJECTIVES:

I. To determine whether the addition of bevacizumab to chemotherapy, or the substitution of cisplatin with topotecan improve the health related quality of life (QOL) as measured by the Functional Assessment of Cancer Therapy-Cervix Trial Outcome Index scale (FACT-Cx TOI) and produce favorable toxicity profiles (with a particular focus on peripheral neuropathy as measured by the Functional Assessment of Cancer Therapy-Gynecologic Oncology Group-Neurotoxicity version 4 [FACT/GOG-Ntx4] subscale and pain as measured by Brief Pain Inventory [BPI] single item).

II. To evaluate the impact of age, race, performance status, stage, histology, grade, disease site, prior chemotherapy with primary radiation, and time to recurrence on response rate, progression-free survival and overall survival of patients with metastatic/recurrent/persistent carcinoma of the cervix.

III. To determine the prevalence of active smoking in this cohort of recurrent cervical cancer patients.

IV. To estimate the extent of tobacco/nicotine dependence in the cohort. V. To determine if smoking is an independent risk factor for progression-free survival and overall survival in this population.

VI. To isolate, enumerate and characterize circulating tumor cells (CTC) recovered from blood drawn pre-cycle 1, pre-cycle 2 and pre-cycle 3 using the CTC-chip developed by the Massachusetts General Hospital (MGH) BioMEMS Resource Center and the MGH Cancer Center.

VII. To determine the association between CTC counts or characteristics and measures of clinical outcome.

VIII. To examine the association between angiogenesis markers in plasma (recovered from blood drawn pre-cycle 1, pre-cycle 2 and pre-cycle 3) and measures of clinical outcome.

IX. To evaluate the association between tumor markers of angiogenesis and hypoxia (using archival formalin-fixed and paraffin-embedded tumor tissue) and measures of clinical outcome.

X. To evaluate the association between single nucleotide polymorphisms (using deoxyribonucleic acid [DNA] extracted from whole blood) and measures of clinical outcome as well as measures of quality of life such as chemotherapy toxicity.

XI. To examine the relationship(s) among the various biomarkers. XII. To develop an optimal prognostic model for progression-free survival and overall survival using clinical covariates, smoking status and the various biomarkers.

OUTLINE: Patients are randomized to 1 of 4 treatment arms.

ARM I: Patients receive paclitaxel intravenously (IV) over 3 hours or 24 hours on day 1 and cisplatin IV on day 1 or 2.

ARM II: Patients receive paclitaxel IV over 3 hours or 24 hours on day 1 and cisplatin IV and bevacizumab IV over 30-90 minutes on day 1 or 2.

ARM III: Patients receive paclitaxel IV over 3 hours on day 1 and topotecan hydrochloride IV over 30 minutes on days 1-3.

ARM IV: Patients receive paclitaxel IV over 3 hours and bevacizumab IV over 30-90 minutes on day 1 and topotecan hydrochloride IV over 30 minutes on days 1-3.

In all arms, 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)

452

Phase

  • Phase 3

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

      • Barcelona, Spain, 08035
        • Vall d'Hebrón University Hospital
      • Cordoba, Spain, 14004
        • Hospital Reina Sofia
      • Girona, Spain, 17007
        • Hospital Universitari de Girona Doctor Josep Trueta
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz
      • Madrid, Spain, 28007
        • Hospital Universitario Gregorio Marañón
      • Madrid, Spain, 28033
        • M D Anderson International Spain
      • Palma, Spain, 07198
        • Hospital Son Llatzer
      • Valencia, Spain, 46009
        • Instituto Valenciano De Oncologia
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • University of Alabama at Birmingham Cancer Center
      • Mobile, Alabama, United States, 36688
        • University of South Alabama Mitchell Cancer Institute
    • Arizona
      • Phoenix, Arizona, United States, 85013
        • Saint Joseph's Hospital and Medical Center
    • Arkansas
      • Fayetteville, Arkansas, United States, 72703
        • Highlands Oncology Group PA - Fayetteville
      • Fayetteville, Arkansas, United States, 72703
        • Washington Regional Medical Center - Fayetteville
      • Little Rock, Arkansas, United States, 72205
        • University of Arkansas for Medical Sciences
    • California
      • Berkeley, California, United States, 94704
        • Alta Bates Summit Medical Center-Herrick Campus
      • Burbank, California, United States, 91505
        • Providence Saint Joseph Medical Center/Disney Family Cancer Center
      • Burbank, California, United States, 91505
        • Roy and Patricia Disney Family Cancer Center
      • Burlingame, California, United States, 94010
        • Mills - Peninsula Hospitals
      • Concord, California, United States, 94520
        • John Muir Medical Center-Concord Campus
      • Duarte, California, United States, 91010
        • City of Hope Comprehensive Cancer Center
      • Fresno, California, United States, 93720
        • California Cancer Center - North Fresno
      • Long Beach, California, United States, 90806
        • Long Beach Memorial Medical Center-Todd Cancer Institute
      • 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, 90095
        • UCLA / Jonsson Comprehensive Cancer Center
      • Los Angeles, California, United States, 90027
        • Kaiser Permanente Los Angeles Medical Center
      • Mountain View, California, United States, 94040
        • Palo Alto Medical Foundation-Gynecologic Oncology
      • Novato, California, United States, 94945
        • Sutter Cancer Research Consortium
      • Orange, California, United States, 92868
        • UC Irvine Health/Chao Family Comprehensive Cancer Center
      • Orange, California, United States, 92868
        • Saint Joseph Hospital - Orange
      • Palo Alto, California, United States, 94304
        • Stanford Cancer Institute
      • Sacramento, California, United States, 95817
        • University of California Davis Comprehensive Cancer Center
      • San Diego, California, United States, 92103
        • University of California San Diego
      • San Francisco, California, United States, 94115
        • UCSF Medical Center-Mount Zion
      • San Francisco, California, United States, 94118
        • California Pacific Medical Center-Pacific Campus
      • Sylmar, California, United States, 91342
        • Olive View-University of California Los Angeles Medical Center
      • Vallejo, California, United States, 94589
        • Sutter Solano Medical Center/Cancer Center
      • Walnut Creek, California, United States, 94598
        • John Muir Medical Center-Walnut Creek
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Cancer Center - Anschutz Cancer Pavilion
      • Aurora, Colorado, United States, 80012
        • The Medical Center of Aurora
      • Aurora, Colorado, United States, 80010
        • Colorado Gynecologic Oncology Group
      • Boulder, Colorado, United States, 80301
        • Boulder Community Hospital
      • Colorado Springs, Colorado, United States, 80907
        • Penrose-Saint Francis Healthcare
      • Denver, Colorado, United States, 80210
        • Porter Adventist Hospital
      • Denver, Colorado, United States, 80218
        • Presbyterian - Saint Lukes Medical Center - Health One
      • Denver, Colorado, United States, 80220
        • Rose Medical Center
      • Denver, Colorado, United States, 80218
        • Exempla Saint Joseph Hospital
      • Denver, Colorado, United States, 80224-2522
        • Colorado Cancer Research Program CCOP
      • Englewood, Colorado, United States, 80113
        • Swedish Medical Center
      • Englewood, Colorado, United States, 80110
        • Rocky Mountain Gynecologic Oncology PC
      • Fort Collins, Colorado, United States, 80524
        • Poudre Valley Hospital
      • Fort Collins, Colorado, United States, 80528
        • Front Range Cancer Specialists
      • Grand Junction, Colorado, United States, 81502
        • Saint Mary's Hospital and Regional Medical Center
      • Greeley, Colorado, United States, 80631
        • North Colorado Medical Center
      • Lakewood, Colorado, United States, 80228
        • Saint Anthony Hospital
      • Littleton, Colorado, United States, 80122
        • Littleton Adventist Hospital
      • Lone Tree, Colorado, United States, 80124
        • Sky Ridge Medical Center
      • Longmont, Colorado, United States, 80501
        • Longmont United Hospital
      • Loveland, Colorado, United States, 80539
        • McKee Medical Center
      • Parker, Colorado, United States, 80138
        • Parker Adventist Hospital
      • Pueblo, Colorado, United States, 81004
        • Saint Mary Corwin Medical Center
      • Thornton, Colorado, United States, 80229
        • North Suburban Medical Center
      • Wheat Ridge, Colorado, United States, 80033
        • Exempla Lutheran Medical Center
    • Connecticut
      • Hartford, Connecticut, United States, 06102
        • Hartford Hospital
      • Hartford, Connecticut, United States, 06105
        • Saint Francis Hospital and Medical Center
      • New Britain, Connecticut, United States, 06050
        • The Hospital of Central Connecticut
    • Delaware
      • Lewes, Delaware, United States, 19958
        • Beebe Medical Center
      • Newark, Delaware, United States, 19718
        • Christiana Care Health System-Christiana Hospital
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Washington Hospital Center
    • Florida
      • Fort Lauderdale, Florida, United States, 33316
        • Broward Health Medical Center
      • Fort Myers, Florida, United States, 33905
        • Florida Gynecologic Oncology
      • Hollywood, Florida, United States, 33021
        • Memorial Healthcare System - Joe DiMaggio Children's Hospital
      • Jacksonville, Florida, United States, 32224-9980
        • Mayo Clinic in Florida
      • Lakeland, Florida, United States, 33805
        • Lakeland Regional Cancer Center
      • Orlando, Florida, United States, 32803
        • Florida Hospital Orlando
      • Orlando, Florida, United States, 32806
        • UF Cancer Center at Orlando Health
      • Sarasota, Florida, United States, 34239
        • Sarasota Memorial Hospital
      • Tampa, Florida, United States, 33612
        • Moffitt Cancer Center
    • Georgia
      • Atlanta, Georgia, United States, 30303
        • Grady Health System
      • Atlanta, Georgia, United States, 30309
        • Piedmont Hospital
      • Atlanta, Georgia, United States, 30322
        • Emory University/Winship Cancer Institute
      • Atlanta, Georgia, United States, 30342
        • Northside Hospital
      • Atlanta, Georgia, United States, 30342
        • Saint Joseph's Hospital of Atlanta
      • Atlanta, Georgia, United States, 30342
        • Atlanta Regional CCOP
      • Augusta, Georgia, United States, 30912
        • Georgia Regents University Medical Center
      • Austell, Georgia, United States, 30106
        • Well Star Cobb Hospital
      • Columbus, Georgia, United States, 31904
        • John B Amos Cancer Center
      • Decatur, Georgia, United States, 30033
        • Dekalb Medical Center
      • Fayetteville, Georgia, United States, 30214
        • Piedmont Fayette Hospital
      • Gainesville, Georgia, United States, 30501
        • Northeast Georgia Medical Center
      • Lawrenceville, Georgia, United States, 30045
        • Gwinnett Medical Center
      • Macon, Georgia, United States, 31201
        • Central Georgia Gynecologic Oncology
      • Marietta, Georgia, United States, 30060
        • Wellstar Kennestone Hospital
      • Riverdale, Georgia, United States, 30274
        • Southern Regional Medical Center
      • Rome, Georgia, United States, 30165
        • Harbin Clinic Medical Oncology and Clinical Research
      • Savannah, Georgia, United States, 31404
        • Memorial University Medical Center
    • Hawaii
      • 'Aiea, Hawaii, United States, 96701
        • Pali Momi Medical Center
      • Honolulu, Hawaii, United States, 96813
        • Queen's Medical Center
      • Honolulu, Hawaii, United States, 96817
        • The Cancer Center of Hawaii-Liliha
      • Honolulu, Hawaii, United States, 96813
        • Straub Clinic and Hospital
      • Honolulu, Hawaii, United States, 96813
        • University of Hawaii Cancer Center
      • Honolulu, Hawaii, United States, 96826
        • Kapiolani Medical Center for Women and Children
      • Honolulu, Hawaii, United States, 96813
        • Oncare Hawaii Inc-POB II
      • Honolulu, Hawaii, United States, 96817
        • Oncare Hawaii Inc-Kuakini
      • Lihue, Hawaii, United States, 96766
        • Wilcox Memorial Hospital and Kauai Medical Clinic
      • Wailuku, Hawaii, United States, 96793
        • Maui Memorial Medical Center
      • Wailuku, Hawaii, United States, 96793
        • Pacific Cancer Institute of Maui
    • Idaho
      • Boise, Idaho, United States, 83706
        • Saint Alphonsus Cancer Care Center-Boise
    • Illinois
      • Bloomington, Illinois, United States, 61704
        • Illinois CancerCare-Bloomington
      • Bloomington, Illinois, United States, 61701
        • Saint Joseph Medical Center
      • Canton, Illinois, United States, 61520
        • Illinois CancerCare-Canton
      • Canton, Illinois, United States, 61520
        • Graham Hospital Association
      • Carthage, Illinois, United States, 62321
        • Illinois CancerCare-Carthage
      • Carthage, Illinois, United States, 62321
        • Memorial Hospital
      • 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
      • Chicago, Illinois, United States, 60608
        • Mount Sinai Hospital Medical Center
      • Chicago, Illinois, United States, 60625
        • Swedish Covenant Hospital
      • Chicago, Illinois, United States, 60612-3785
        • John H Stroger Jr Hospital of Cook County
      • Decatur, Illinois, United States, 62526
        • Decatur Memorial Hospital
      • Eureka, Illinois, United States, 61530
        • Illinois CancerCare-Eureka
      • Eureka, Illinois, United States, 61530
        • Eureka Hospital
      • Evanston, Illinois, United States, 60202
        • Saint Francis Hospital
      • Galesburg, Illinois, United States, 61401
        • Illinois CancerCare Galesburg
      • Havana, Illinois, United States, 62644
        • Mason District Hospital
      • Havana, Illinois, United States, 62644
        • Illinois CancerCare-Havana
      • Hinsdale, Illinois, United States, 60521
        • Sudarshan K Sharma MD Limted-Gynecologic Oncology
      • Joliet, Illinois, United States, 60435
        • Joliet Oncology-Hematology Associates Limited
      • Kankakee, Illinois, United States, 60901
        • Presence Saint Mary's Hospital
      • Kewanee, Illinois, United States, 61443
        • Illinois CancerCare-Kewanee Clinic
      • Macomb, Illinois, United States, 61455
        • Illinois CancerCare-Macomb
      • Macomb, Illinois, United States, 61455
        • Mcdonough District Hospital
      • Maywood, Illinois, United States, 60153
        • Loyola University Medical Center
      • Monmouth, Illinois, United States, 61462
        • Illinois CancerCare-Monmouth
      • Monmouth, Illinois, United States, 61462
        • Holy Family Medical Center
      • Normal, Illinois, United States, 61761
        • Community Cancer Center Foundation
      • Normal, Illinois, United States, 61761
        • Bromenn Regional Medical Center
      • Normal, Illinois, United States, 61761
        • Illinois CancerCare-Community Cancer Center
      • Oak Lawn, Illinois, United States, 60453-2699
        • Advocate Christ Medical Center
      • Ottawa, Illinois, United States, 61350
        • Illinois CancerCare-Ottawa Clinic
      • Ottawa, Illinois, United States, 61350
        • Ottawa Regional Hospital and Healthcare Center
      • Park Ridge, Illinois, United States, 60068
        • Advocate Lutheran General Hospital.
      • Pekin, Illinois, United States, 61554
        • Illinois CancerCare-Pekin
      • Pekin, Illinois, United States, 61554
        • Pekin Cancer Treatment Center
      • 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
      • Peru, Illinois, United States, 61354
        • Illinois Valley Hospital
      • Princeton, Illinois, United States, 61356
        • Illinois CancerCare-Princeton
      • Princeton, Illinois, United States, 61356
        • Perry Memorial Hospital
      • Spring Valley, Illinois, United States, 61362
        • Illinois CancerCare-Spring Valley
      • Springfield, Illinois, United States, 62781-0001
        • Memorial Medical Center
      • Warrenville, Illinois, United States, 60555
        • Cadence Cancer Center in Warrenville
    • Indiana
      • Beech Grove, Indiana, United States, 46107
        • Saint Francis Hospital and Health Centers
      • Elkhart, Indiana, United States, 46515
        • Elkhart General Hospital
      • Elkhart, Indiana, United States, 46514
        • Michiana Hematology Oncology PC-Elkhart
      • Elkhart, Indiana, United States, 46514-2098
        • Elkhart Clinic
      • Fort Wayne, Indiana, United States, 46845
        • Fort Wayne Medical Oncology and Hematology Inc-Parkview
      • Indianapolis, Indiana, United States, 46202
        • Indiana University/Melvin and Bren Simon Cancer Center
      • Indianapolis, Indiana, United States, 46260
        • Saint Vincent Oncology Center
      • Indianapolis, Indiana, United States, 46260
        • Saint Vincent Hospital and Health Services
      • Indianapolis, Indiana, United States, 46237
        • Franciscan Saint Francis Health-Indianapolis
      • Indianapolis, Indiana, United States, 46237
        • Gynecologic Oncology of Indiana
      • Kokomo, Indiana, United States, 46904
        • Community Howard Regional Health
      • La Porte, Indiana, United States, 46350
        • IU Health La Porte Hospital
      • Mishawaka, Indiana, United States, 46545
        • Michiana Hematology Oncology PC-Mishawaka
      • Mishawaka, Indiana, United States, 46545
        • Saint Joseph Regional Medical Center-Mishawaka
      • Munster, Indiana, United States, 46321
        • The Community Hospital
      • Plymouth, Indiana, United States, 46563
        • Michiana Hematology Oncology PC-Plymouth
      • Richmond, Indiana, United States, 47374
        • Reid Hospital and Health Care Services
      • South Bend, Indiana, United States, 46601
        • Memorial Hospital of South Bend
      • South Bend, Indiana, United States, 46601
        • Michiana Hematology Oncology PC-South Bend
      • South Bend, Indiana, United States, 46617
        • South Bend Clinic
      • South Bend, Indiana, United States, 46628
        • Northern Indiana Cancer Research Consortium CCOP
      • Westville, Indiana, United States, 46391
        • Michiana Hematology Oncology-PC Westville
    • Iowa
      • Ames, Iowa, United States, 50010
        • McFarland Clinic PC-William R Bliss Cancer Center
      • 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, 50307
        • Mercy Capitol
      • Des Moines, Iowa, United States, 50309
        • Iowa Oncology Research Association CCOP
      • Iowa City, Iowa, United States, 52242
        • University of Iowa/Holden Comprehensive Cancer Center
      • Sioux City, Iowa, United States, 51104
        • Saint Luke's Regional Medical Center
      • Sioux City, Iowa, United States, 51104
        • Mercy Medical Center-Sioux City
    • Kansas
      • Anthony, Kansas, United States, 67003
        • Hospital District Sixth of Harper County
      • 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
      • 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
      • Liberal, Kansas, United States, 67901
        • Cancer Center of Kansas-Liberal
      • McPherson, Kansas, United States, 67460
        • Cancer Center of Kansas - McPherson
      • Newton, Kansas, United States, 67114
        • Cancer Center of Kansas - Newton
      • Overland Park, Kansas, United States, 66209
        • Menorah Medical Center
      • Overland Park, Kansas, United States, 66213
        • Saint Luke's South Hospital
      • Parsons, Kansas, United States, 67357
        • Cancer Center of Kansas - Parsons
      • Prairie Village, Kansas, United States, 66208
        • Kansas City CCOP
      • Pratt, Kansas, United States, 67124
        • Cancer Center of Kansas - Pratt
      • Salina, Kansas, United States, 67401
        • Cancer Center of Kansas - Salina
      • Shawnee Mission, Kansas, United States, 66204
        • Shawnee Mission Medical Center
      • 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
      • Edgewood, Kentucky, United States, 41017
        • Saint Elizabeth Medical Center South
      • Lexington, Kentucky, United States, 40536
        • University of Kentucky/Markey Cancer Center
      • Lexington, Kentucky, United States, 40503
        • Baptist Health Lexington
      • Louisville, Kentucky, United States, 40202
        • Norton Hospital Pavilion and Medical Campus
      • Louisville, Kentucky, United States, 40215
        • Doctors Carrol, Sheth, Raghavan
      • Pikeville, Kentucky, United States, 41501
        • Pikeville Medical Center
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
        • Hematology/Oncology Clinic LLP
      • Baton Rouge, Louisiana, United States, 70817
        • Woman's Hospital
      • New Orleans, Louisiana, United States, 70121
        • Ochsner Medical Center Jefferson
      • New Orleans, Louisiana, United States, 70112
        • Tulane University Health Sciences Center
      • Shreveport, Louisiana, United States, 71103
        • Louisiana State University Health Sciences Center Shreveport
      • Shreveport, Louisiana, United States, 71105
        • Highland Clinic
    • Maine
      • Portland, Maine, United States, 04102
        • Maine Medical Center-Bramhall Campus
    • Maryland
      • Baltimore, Maryland, United States, 21215
        • Sinai Hospital of Baltimore
      • Baltimore, Maryland, United States, 21204
        • Greater Baltimore Medical Center
      • Baltimore, Maryland, United States, 21201
        • University of Maryland/Greenebaum Cancer Center
      • Baltimore, Maryland, United States, 21237
        • Franklin Square Hospital Center
      • Elkton, Maryland, United States, 21921
        • Union Hospital of Cecil County
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Dana-Farber Cancer Institute
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital
      • Boston, Massachusetts, United States, 02111
        • Tufts Medical Center
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital Cancer Center
      • Springfield, Massachusetts, United States, 01199
        • Baystate Medical Center
      • Worcester, Massachusetts, United States, 01605
        • University of Massachusetts Memorial Health Care
    • Michigan
      • Ann Arbor, Michigan, United States, 48106-0995
        • Saint Joseph Mercy Hospital
      • Ann Arbor, Michigan, United States, 48106
        • Michigan Cancer Research Consortium CCOP
      • Battle Creek, Michigan, United States, 49017
        • Bronson Battle Creek
      • Big Rapids, Michigan, United States, 49307
        • Spectrum Health Big Rapids Hospital
      • Dearborn, Michigan, United States, 48124
        • Oakwood Hospital and Medical Center
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital
      • Detroit, Michigan, United States, 48236
        • Saint John Hospital and Medical Center
      • Detroit, Michigan, United States, 48201
        • Wayne State University/Karmanos Cancer Institute
      • Escanaba, Michigan, United States, 49431
        • Green Bay Oncology - Escanaba
      • Flint, Michigan, United States, 48502
        • Hurley Medical Center
      • Flint, Michigan, United States, 48532
        • Genesys Regional Medical Center-West Flint Campus
      • Grand Rapids, Michigan, United States, 49503
        • Spectrum Health at Butterworth Campus
      • Grand Rapids, Michigan, United States, 49503
        • Mercy Health Saint Mary's
      • Grand Rapids, Michigan, United States, 49503
        • Grand Rapids Clinical Oncology Program
      • Iron Mountain, Michigan, United States, 49801
        • Green Bay Oncology - Iron Mountain
      • 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
      • Midland, Michigan, United States, 48670
        • Mid-Michigan Medical Center - Midland
      • Muskegon, Michigan, United States, 49444
        • Mercy Health Mercy Campus
      • Niles, Michigan, United States, 49120
        • Michiana Hematology Oncology PC-Niles
      • Pontiac, Michigan, United States, 48341
        • Saint Joseph Mercy Oakland
      • Port Huron, Michigan, United States, 48060
        • Saint Joseph Mercy Port Huron
      • Royal Oak, Michigan, United States, 48073
        • William Beaumont Hospital-Royal Oak
      • Saginaw, Michigan, United States, 48601
        • Saint Mary's of Michigan
      • Saint Joseph, Michigan, United States, 49085
        • Marie Yeager Cancer Center
      • Saint Joseph, Michigan, United States, 49085
        • Lakeland Hospital
      • Southfield, Michigan, United States, 48075
        • Providence Hospital
      • Traverse City, Michigan, United States, 49684
        • Munson Medical Center
      • Warren, Michigan, United States, 48093
        • Saint John Macomb-Oakland Hospital
      • Wyoming, Michigan, United States, 49519
        • Metro Health 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
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota Medical Center-Fairview
      • Robbinsdale, Minnesota, United States, 55422
        • North Memorial Medical Health Center
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
      • Saint Louis Park, Minnesota, United States, 55416
        • Park Nicollet Clinic - Saint Louis Park
      • Saint Louis Park, Minnesota, United States, 55416
        • Metro-Minnesota NCI Community Oncology Research Program
      • 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
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • University of Mississippi Medical Center
      • Pascagoula, Mississippi, United States, 39581
        • Singing River Hospital
    • Missouri
      • Kansas City, Missouri, United States, 64116
        • North Kansas City Hospital
      • Kansas City, Missouri, United States, 64111
        • Saint Luke's Hospital of Kansas City
      • Kansas City, Missouri, United States, 64132
        • Research Medical Center
      • Kansas City, Missouri, United States, 64108
        • Truman Medical Center
      • Kansas City, Missouri, United States, 64118
        • Heartland Hematology and Oncology Associates Incorporated
      • Kansas City, Missouri, United States, 64111
        • Saint Luke's Cancer Institute
      • Kansas City, Missouri, United States, 64114
        • Saint Joseph Health Center
      • Lee's Summit, Missouri, United States, 64086
        • Saint Luke's East - Lee's Summit
      • Liberty, Missouri, United States, 64068
        • Liberty Radiation Oncology Center
      • Liberty, Missouri, United States, 64068
        • Liberty Hospital
      • Rolla, Missouri, United States, 65401
        • Phelps County Regional Medical Center
      • Saint Joseph, Missouri, United States, 64506
        • Heartland Regional Medical Center
      • Saint Joseph, Missouri, United States, 64507
        • Saint Joseph Oncology Inc
      • Saint Louis, Missouri, United States, 63110
        • Saint Louis University Hospital
      • Springfield, Missouri, United States, 65807
        • CoxHealth South Hospital
      • Springfield, Missouri, United States, 65804
        • Mercy Hospital Springfield
      • Springfield, Missouri, United States, 65804
        • Ozark Health Ventures LLC-Cancer Research for The Ozarks Springfield
    • Montana
      • Billings, Montana, United States, 59101
        • Saint Vincent Healthcare
      • Billings, Montana, United States, 59101
        • Northern Rockies Radiation Oncology Center
      • Billings, Montana, United States, 59101
        • Montana Cancer Consortium CCOP
      • Billings, Montana, United States, 59102
        • Frontier Cancer Center and Blood Institute-Billings
      • Billings, Montana, United States, 59107
        • Billings Clinic Cancer Center
      • Bozeman, Montana, United States, 59715
        • Bozeman Deaconess Hospital
      • Bozeman, Montana, United States, 59715
        • Bozeman Deaconess Cancer Center
      • 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
      • Great Falls, Montana, United States, 59405
        • Berdeaux, Donald MD (UIA Investigator)
      • Havre, Montana, United States, 59501
        • Northern Montana Hospital
      • Helena, Montana, United States, 59601
        • Saint Peter's Community Hospital
      • Kalispell, Montana, United States, 59901
        • Kalispell Regional Medical Center
      • Kalispell, Montana, United States, 59901
        • Glacier Oncology PLLC
      • Kalispell, Montana, United States, 59901
        • Kalispell Medical Oncology
      • Missoula, Montana, United States, 59802
        • Saint Patrick Hospital - Community Hospital
      • Missoula, Montana, United States, 59804
        • Guardian Oncology and Center for Wellness
      • Missoula, Montana, United States, 59801
        • Community Medical Hospital
      • Missoula, Montana, United States, 59802
        • Montana Cancer Specialists
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Nebraska Methodist Hospital
      • Omaha, Nebraska, United States, 68198
        • University of Nebraska Medical Center
    • Nevada
      • Las Vegas, Nevada, United States, 89169
        • Women's Cancer Center of Nevada
      • Reno, Nevada, United States, 89502
        • Renown Regional Medical Center
      • Reno, Nevada, United States, 89502
        • Center of Hope at Renown Medical Center
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth Hitchcock Medical Center
    • New Jersey
      • Camden, New Jersey, United States, 08103
        • Cooper Hospital University Medical Center
      • Morristown, New Jersey, United States, 07962
        • Morristown Memorial Hospital
      • Mount Holly, New Jersey, United States, 08060
        • Fox Chase Cancer Center at Virtua Memorial Hospital of Burlington County
      • Neptune, New Jersey, United States, 07753
        • Jersey Shore Medical Center
      • New Brunswick, New Jersey, United States, 08903
        • Rutgers Cancer Institute of New Jersey
      • Newark, New Jersey, United States, 07103
        • UMDNJ - New Jersey Medical School
      • Phillipsburg, New Jersey, United States, 08865
        • The Women's Institute for Gynecologic Cancer and Special Pelvic Surgery
      • Ridgewood, New Jersey, United States, 07450
        • Valley Hospital
      • Summit, New Jersey, United States, 07902
        • Overlook Hospital
      • Vineland, New Jersey, United States, 08360
        • Inspira Medical Center Vineland
      • Voorhees, New Jersey, United States, 08043
        • Virtua West Jersey Hospital Voorhees
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
        • Southwest Gynecologic Oncology Associates Inc
      • Albuquerque, New Mexico, United States, 87106
        • University of New Mexico Cancer Center
    • New York
      • Albany, New York, United States, 12208
        • Women's Cancer Care Associates LLC
      • Brightwaters, New York, United States, 11718
        • Island Gynecologic Oncology
      • Bronx, New York, United States, 10461
        • Montefiore Medical Center-Einstein Campus
      • Brooklyn, New York, United States, 11203
        • State University of New York Downstate Medical Center
      • Jamaica, New York, United States, 11432
        • Queens Hospital Center
      • Manhasset, New York, United States, 11030
        • North Shore University Hospital
      • Manhasset, New York, United States, 11030
        • North Shore-LIJ Health System CCOP
      • Middletown, New York, United States, 10940
        • Orange Regional Medical Center
      • New Hyde Park, New York, United States, 11040
        • Long Island Jewish Medical Center
      • New Hyde Park, New York, United States, 11040
        • North Shore-LIJ Health System/Center for Advanced Medicine
      • New York, New York, United States, 10032
        • Columbia University Medical Center
      • New York, New York, United States, 10065
        • Memorial Sloan-Kettering Cancer Center
      • New York, New York, United States, 10065
        • Weill Medical College of Cornell University
      • New York, New York, United States, 10003
        • Beth Israel Medical Center
      • New York, New York, United States, 10016
        • New York University Langone Medical Center
      • New York, New York, United States, 10025
        • Saint Luke's Roosevelt Hospital Center - Saint Luke's Division
      • Stony Brook, New York, United States, 11794
        • Stony Brook University Medical Center
      • Syracuse, New York, United States, 13210
        • State University of New York Upstate Medical University
    • North Carolina
      • Asheboro, North Carolina, United States, 27203
        • Randolph Hospital
      • Asheville, North Carolina, United States, 28816
        • Hope Women's Cancer Centers-Asheville
      • Burlington, North Carolina, United States, 27216
        • Cone Health Cancer Center at Alamance Regional
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina at Chapel Hill
      • Charlotte, North Carolina, United States, 28204
        • Novant Health Presbyterian Medical Center
      • Charlotte, North Carolina, United States, 28203
        • Carolinas Medical Center
      • Goldsboro, North Carolina, United States, 27534
        • Wayne Memorial Hospital
      • Greensboro, North Carolina, United States, 27403
        • Cone Health Cancer Center
      • Kinston, North Carolina, United States, 28501
        • Kinston Medical Specialists PA
      • Reidsville, North Carolina, United States, 27320
        • Annie Penn Memorial Hospital
      • Rutherfordton, North Carolina, United States, 28139
        • Rutherford Hospital
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest University Health Sciences
    • North Dakota
      • Bismarck, North Dakota, United States, 58501
        • Sanford Bismarck Medical Center
      • Bismarck, North Dakota, United States, 58501
        • Mid Dakota Clinic
      • Bismarck, North Dakota, United States, 58501
        • Saint Alexius Medical Center
    • Ohio
      • Akron, Ohio, United States, 44304
        • Summa Akron City Hospital/Cooper Cancer Center
      • Akron, Ohio, United States, 44307
        • Akron General Medical Center
      • Bellefontaine, Ohio, United States, 43311
        • Mary Rutan Hospital
      • Canton, Ohio, United States, 44710
        • Aultman Health Foundation
      • Chillicothe, Ohio, United States, 45601
        • Adena Regional Medical Center
      • Cincinnati, Ohio, United States, 45267
        • University of Cincinnati
      • Cincinnati, Ohio, United States, 45220
        • Good Samaritan Hospital - Cincinnati
      • 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, 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
        • Grady Memorial Hospital
      • 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
      • Kettering, Ohio, United States, 45429
        • Kettering Medical Center
      • Lancaster, Ohio, United States, 43130
        • Fairfield Medical Center
      • Lima, Ohio, United States, 45801
        • Saint Rita's Medical Center
      • Marietta, Ohio, United States, 45750
        • Marietta Memorial Hospital
      • Mayfield Heights, Ohio, United States, 44124
        • Hillcrest Hospital Cancer Center
      • Mentor, Ohio, United States, 44060
        • Lake University Ireland Cancer Center
      • Mount Vernon, Ohio, United States, 43050
        • Knox Community Hospital
      • Newark, Ohio, United States, 43055
        • Licking Memorial Hospital
      • Portsmouth, Ohio, United States, 45662
        • Southern Ohio Medical Center
      • Springfield, Ohio, United States, 45505
        • Springfield Regional Medical Center
      • Troy, Ohio, United States, 45373
        • Upper Valley Medical Center
      • Westerville, Ohio, United States, 43081
        • Saint Ann's Hospital
      • Wilmington, Ohio, United States, 45177
        • Clinton Memorial 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
      • Abington, Pennsylvania, United States, 19001
        • Abington Memorial Hospital
      • Allentown, Pennsylvania, United States, 18103
        • Lehigh Valley Hospital-Cedar Crest
      • Bethlehem, Pennsylvania, United States, 18015
        • Saint Luke's University Hospital-Bethlehem Campus
      • Bryn Mawr, Pennsylvania, United States, 19010
        • Bryn Mawr Hospital
      • Hershey, Pennsylvania, United States, 17033-0850
        • Penn State Milton S Hershey Medical Center
      • Paoli, Pennsylvania, United States, 19301
        • Paoli Memorial Hospital
      • Philadelphia, Pennsylvania, United States, 19111
        • Fox Chase Cancer Center
      • Philadelphia, Pennsylvania, United States, 19140
        • Temple University Hospital
      • Philadelphia, Pennsylvania, United States, 19107
        • Pennsylvania Hospital
      • Pittsburgh, Pennsylvania, United States, 15224
        • West Penn Hospital
      • Pittsburgh, Pennsylvania, United States, 15213
        • UPMC-Magee Womens Hospital
      • West Reading, Pennsylvania, United States, 19611
        • Reading Hospital
      • Wynnewood, Pennsylvania, United States, 19096
        • Lankenau Medical Center
      • Wynnewood, Pennsylvania, United States, 19096
        • Mainline Health CCOP
    • Rhode Island
      • Providence, Rhode Island, United States, 02905
        • Women and Infants Hospital
    • South Carolina
      • Anderson, South Carolina, United States, 29621
        • AnMed Health Cancer Center
      • Anderson, South Carolina, United States, 29621
        • AnMed Health Hospital
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina
      • Columbia, South Carolina, United States, 29210
        • South Carolina Oncology Associates PA
      • Easley, South Carolina, United States, 29640
        • Greenville Health System Cancer Institute-Easley
      • Florence, South Carolina, United States, 29506
        • McLeod Regional Medical Center
      • Greenville, South Carolina, United States, 29601
        • Saint Francis Hospital
      • Greenville, South Carolina, United States, 29605
        • Greenville Health System Cancer Institute-Andrews
      • Greenville, South Carolina, United States, 29605
        • Greenville Health System Cancer Institute-Faris
      • Greenville, South Carolina, United States, 29605
        • Greenville Memorial Hospital
      • Greenville, South Carolina, United States, 29615
        • Greenville Health System Cancer Institute-Eastside
      • Greenville, South Carolina, United States, 29605
        • Greenville Health System Cancer Institute-Butternut
      • Greenwood, South Carolina, United States, 29646
        • Self Regional Healthcare
      • Greer, South Carolina, United States, 29650
        • Greenville Health System Cancer Institute-Greer
      • Greer, South Carolina, United States, 29650
        • Cancer Centers of the Carolinas-Greer Medical Oncology
      • Seneca, South Carolina, United States, 29672
        • Greenville Health System Cancer Institute-Seneca
      • Spartanburg, South Carolina, United States, 29303
        • Spartanburg Medical Center
      • Spartanburg, South Carolina, United States, 29307
        • Greenville Health System Cancer Institute-Spartanburg
      • Spartanburg, South Carolina, United States, 29303
        • Upstate Carolina CCOP
    • South Dakota
      • Rapid City, South Dakota, United States, 57701
        • Black Hills Obstetrics and Gynecology
      • Sioux Falls, South Dakota, United States, 57105
        • Avera Cancer Institute
      • 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
      • Sioux Falls, South Dakota, United States, 57105
        • Medical X-Ray Center
    • Tennessee
      • Kingsport, Tennessee, United States, 37660
        • Wellmont Holston Valley Hospital and Medical Center
      • Knoxville, Tennessee, United States, 37920
        • University of Tennessee - Knoxville
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University/Ingram Cancer Center
      • Nashville, Tennessee, United States, 37208
        • Meharry Medical College
      • Nashville, Tennessee, United States, 37203
        • Tennessee Oncology PLLC- Centennial Medical Center
    • Texas
      • Austin, Texas, United States, 78701
        • University Medical Center Brackenridge
      • Dallas, Texas, United States, 75235
        • Parkland Memorial Hospital
      • Dallas, Texas, United States, 75390
        • UT Southwestern/Simmons Cancer Center-Dallas
      • Dallas, Texas, United States, 75390
        • Clements University Hospital
      • Dallas, Texas, United States, 75235
        • Zale Lipshy University Hospital
      • Fort Sam Houston, Texas, United States, 78234
        • Brooke Army Medical Center
      • Fort Worth, Texas, United States, 76104
        • Baylor All Saints Medical Center at Fort Worth
      • Galveston, Texas, United States, 77555-0565
        • University of Texas Medical Branch at Galveston
      • Houston, Texas, United States, 77030
        • M D Anderson Cancer Center
      • Houston, Texas, United States, 77026-1967
        • Lyndon Baines Johnson General Hospital
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine
      • Houston, Texas, United States, 77030
        • Ben Taub General Hospital
      • Houston, Texas, United States, 77030
        • Methodist Hospital
      • Houston, Texas, United States, 77030
        • Saint Luke's Episcopal Hospital
      • Houston, Texas, United States, 77030
        • Veterans Administration Medical Center
      • Lackland Air Force Base, Texas, United States, 78236
        • Wilford Hall Medical Center
      • Temple, Texas, United States, 76508
        • Scott and White Memorial Hospital
    • Utah
      • American Fork, Utah, United States, 84003
        • American Fork Hospital
      • Cedar City, Utah, United States, 84720
        • Sandra L Maxwell Cancer Center
      • Logan, Utah, United States, 84321
        • Logan Regional Hospital
      • Murray, Utah, United States, 84157
        • Intermountain Medical Center
      • Ogden, Utah, United States, 84403
        • McKay-Dee Hospital Center
      • Provo, Utah, United States, 84604
        • Utah Valley Regional Medical Center
      • Saint George, Utah, United States, 84770
        • Dixie Medical Center Regional Cancer Center
      • Salt Lake City, Utah, United States, 84112
        • Huntsman Cancer Institute/University of Utah
      • Salt Lake City, Utah, United States, 84106
        • Utah Cancer Specialists-Salt Lake City
      • Salt Lake City, Utah, United States, 84143
        • LDS Hospital
      • Salt Lake City, Utah, United States, 84103
        • Intermountain Health Care
    • Vermont
      • Burlington, Vermont, United States, 05401
        • Fletcher Allen Health Care-Medical Center
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia
      • Norton, Virginia, United States, 24273
        • Southwest VA Regional Cancer Center
      • Richmond, Virginia, United States, 23298
        • Virginia Commonwealth University/Massey Cancer Center
      • Roanoke, Virginia, United States, 24016
        • Carilion Clinic Gynecological Oncology
    • Washington
      • Centralia, Washington, United States, 98531
        • Providence Regional Cancer System-Centralia
      • Federal Way, Washington, United States, 98003
        • Saint Francis Hospital
      • Lakewood, Washington, United States, 98499
        • Saint Clare Hospital
      • Olympia, Washington, United States, 98506-5166
        • Providence - Saint Peter Hospital
      • Puyallup, Washington, United States, 98372
        • MultiCare Good Samaritan Hospital
      • Tacoma, Washington, United States, 98405
        • MultiCare Allenmore Hospital
      • Tacoma, Washington, United States, 98405
        • Saint Joseph Medical Center
      • Tacoma, Washington, United States, 98415
        • MultiCare Health System
      • Tacoma, Washington, United States, 98405
        • Northwest CCOP
    • Wisconsin
      • Antigo, Wisconsin, United States, 54409
        • Langlade Hospital and Cancer Center
      • Chippewa Falls, Wisconsin, United States, 54729
        • Marshfield Clinic-Chippewa Center
      • Eau Claire, Wisconsin, United States, 54701
        • Marshfield Clinic Cancer Center at Sacred Heart
      • Green Bay, Wisconsin, United States, 54301
        • Saint Vincent Hospital
      • Green Bay, Wisconsin, United States, 54303
        • Green Bay Oncology Limited at Saint Mary's Hospital
      • Green Bay, Wisconsin, United States, 54303
        • Saint Mary's Hospital
      • Green Bay, Wisconsin, United States, 54301-3526
        • Green Bay Oncology at Saint Vincent Hospital
      • La Crosse, Wisconsin, United States, 54601
        • Gundersen Lutheran Medical Center
      • Madison, Wisconsin, United States, 53792
        • University of Wisconsin Hospital and Clinics
      • Manitowoc, Wisconsin, United States, 54221
        • Holy Family Memorial Hospital
      • Marinette, Wisconsin, United States, 54143
        • Bay Area Medical Center
      • Marshfield, Wisconsin, United States, 54449
        • Marshfield Clinic
      • Marshfield, Wisconsin, United States, 54449
        • Saint Joseph's Hospital
      • Milwaukee, Wisconsin, United States, 53226
        • Froedtert and The Medical College of Wisconsin
      • 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
      • Mukwonago, Wisconsin, United States, 53149
        • D N Greenwald Center
      • Oconomowoc, Wisconsin, United States, 53066-3896
        • Oconomowoc Memorial Hospital-ProHealth Care Inc
      • Oconto Falls, Wisconsin, United States, 54154
        • Green Bay Oncology - Oconto Falls
      • Rhinelander, Wisconsin, United States, 54501
        • Marshfield Clinic at James Beck Cancer Center
      • Rice Lake, Wisconsin, United States, 54868
        • Marshfield Clinic-Rice Lake Center
      • Stevens Point, Wisconsin, United States, 54481
        • Saint Michael's Hospital
      • Stevens Point, Wisconsin, United States, 54481
        • Marshfield Clinic Cancer Care at Saint Michael's Hospital
      • Sturgeon Bay, Wisconsin, United States, 54235
        • Green Bay Oncology - Sturgeon Bay
      • Two Rivers, Wisconsin, United States, 54241
        • Vince Lombardi Cancer Clinic
      • Waukesha, Wisconsin, United States, 53188
        • Waukesha Memorial Hospital
      • Wausau, Wisconsin, United States, 54401
        • Aspirus Regional Cancer Center
      • West Allis, Wisconsin, United States, 53227
        • Aurora West Allis Medical Center
      • Weston, Wisconsin, United States, 54476
        • Marshfield Clinic - Weston Center
      • Wisconsin Rapids, Wisconsin, United States, 54494
        • Marshfield Clinic - Wisconsin Rapids Center
    • Wyoming
      • Casper, Wyoming, United States, 82609
        • Rocky Mountain Oncology
      • 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

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Patients must have primary stage IVB, recurrent or persistent squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix which is not amenable to curative treatment with surgery and/or radiation therapy
  • All patients must have measurable disease; measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest dimension to be recorded); each lesion must be >= 20 mm when measured by conventional techniques, including palpation, plain x-ray, computed tomography (CT), and magnetic resonance imaging (MRI), or >= 10 mm when measured by spiral CT; biopsy confirmation is required if the lesion(s) measures < 30 mm or if the treating physician determines it is clinically indicated; patients must have at least one "target lesion" to be used to assess response on this protocol as defined by Response Evaluation Criteria in Solid Tumors (RECIST); this lesion should be the one that was biopsied if one was performed; tumors within a previously irradiated field will be designated as "non-target" lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy
  • Absolute neutrophil count (ANC) >= 1500/mcl
  • Platelets >= 100,000/mcl
  • Serum creatinine =< upper limit of normal (ULN) (Common Toxicity Criteria [CTC] grade 0) or calculated creatinine clearance (Jeliffe formula) >= 60 ml/min
  • Bilirubin =< 1.5 x institutional normal
  • Serum glutamic oxaloacetic transaminase (SGOT) =< 2.5 x institutional normal
  • Alkaline phosphatase =< 2.5 x institutional normal
  • Prothrombin time (PT) such that international normalized ratio (INR) is =< 1.5 (or an in-range INR, usually between 2 and 3, if a patient is on a stable dose of therapeutic warfarin for management of venous thrombosis including pulmonary thrombo-embolus)
  • Partial thromboplastin time (PTT) < 1.2 times the upper limit of normal
  • Urine protein-creatinine ratio (UPC ratio) < 1.0
  • Patients must have a GOG performance status of 0 or 1
  • Patients must have recovered from the effects of surgery, radiation therapy, or chemoradiotherapy; at least six weeks must have elapsed from the last administration of chemoradiotherapy, and at least three weeks must have elapsed from the last administration of radiation therapy alone; at least six weeks must have elapsed from the time of any major surgical procedure prior to randomization
  • Patients must have signed an approved informed consent and authorization permitting release of personal health information
  • Patients must meet all of the pre-entry requirements, including baseline QOL questionnaire
  • Patients must be free of active infection requiring antibiotics

Exclusion Criteria:

  • Patients with bilateral hydronephrosis which cannot be alleviated by ureteral stents or percutaneous drainage
  • Patients previously treated with chemotherapy except when used concurrently with radiation therapy

    • Patients who have received concurrent paclitaxel and/or concurrent topotecan with radiation therapy are ineligible
  • Patients with craniospinal metastases
  • Patients with a concomitant malignancy other than non-melanoma skin cancer
  • Patients with a prior invasive malignancy (except non-melanoma skin cancer) who have had any evidence of disease within the last 5 years or whose prior malignancy treatment contraindicates the current protocol therapy
  • Patients with serious non-healing wound, ulcer, or bone fracture; this includes history of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess for which an interval of 3 to 6 months must pass before study entry; in addition, the patient must have undergone correction (or spontaneous healing) of the perforation/fistula and/or the underlying process causing the fistula/perforation; patients with granulating incisions healing by secondary intention with no evidence of fascial dehiscence or infection are eligible but require weekly wound examinations
  • Patients with active bleeding or pathologic conditions that carry high risk of bleeding, such as known bleeding disorder, coagulopathy, or tumor involving major vessels
  • Patients with history or evidence upon physical examination of central nervous system (CNS) disease, including primary brain tumor, seizures not controlled with standard medical therapy, any brain metastases, or history of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) or subarachnoid hemorrhage within six months of the first date of treatment on this study
  • Patients with clinically significant cardiovascular disease; this includes:

    • Uncontrolled hypertension, defined as systolic > 150 mm Hg or diastolic > 90 mm Hg
    • Myocardial infarction or unstable angina < 6 months prior to registration
    • New York Heart Association (NYHA) grade II or greater congestive heart failure
    • Serious cardiac arrhythmia requiring medication; this does not include asymptomatic, atrial fibrillation with controlled ventricular rate
    • CTCAE grade 2 or greater peripheral vascular disease (at least brief [< 24 hours (hrs)]) episodes of ischemia managed non-surgically and without permanent deficit)
    • History of CVA within six months
  • Patients with known hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies
  • Patients with or with anticipation of invasive procedures as defined below:

    • Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to the first date of bevacizumab therapy
    • Major surgical procedure anticipated during the course of the study; this includes, but is not limited to abdominal surgery (laparotomy or laparoscopy) prior to disease progression, such as colostomy or enterostomy reversal, interval or secondary cytoreductive surgery, or second look surgery; please consult with the study chair prior to patient entry for any questions related to the classification of surgical procedures
    • Core biopsy, within 7 days prior to randomization
  • Patients who are pregnant or nursing; bevacizumab should not be administered to pregnant women; bevacizumab should not be administered to nursing women; patients of childbearing potential must agree to use contraceptive measures during study therapy and for at least six months after completion of bevacizumab therapy
  • Patients who have received prior therapy with any anti-vascular endothelial growth factor (VEGF) drug, including bevacizumab
  • Patients with clinical symptoms or signs of gastrointestinal obstruction and who require parenteral hydration and/or nutrition
  • Patients with medical history or conditions not otherwise previously specified which in the opinion of the investigator should exclude participation in this study; the investigator should feel free to consult the Study Chair or Study Co-Chairs for uncertainty in this regard
  • Patients with significant peripheral vascular disease
  • Patients with pre-existing grade 2 or greater peripheral neuropathy

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)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Arm I (paclitaxel and cisplatin)
Patients receive paclitaxel IV over 3 hours or 24 hours on day 1 and cisplatin IV on day 1 or 2.
Correlative studies
Ancillary studies
Other Names:
  • Quality of Life Assessment
Ancillary studies
Given IV
Other Names:
  • CDDP
  • Cis-diamminedichloridoplatinum
  • Cismaplat
  • Cisplatinum
  • Neoplatin
  • Platinol
  • Abiplatin
  • Blastolem
  • Briplatin
  • Cis-diammine-dichloroplatinum
  • Cis-diamminedichloro Platinum (II)
  • Cis-diamminedichloroplatinum
  • Cis-dichloroammine Platinum (II)
  • Cis-platinous Diamine Dichloride
  • Cis-platinum
  • Cis-platinum II
  • Cis-platinum II Diamine Dichloride
  • Cisplatina
  • Cisplatyl
  • Citoplatino
  • Citosin
  • Cysplatyna
  • DDP
  • Lederplatin
  • Metaplatin
  • Peyrone's Chloride
  • Peyrone's Salt
  • Placis
  • Plastistil
  • Platamine
  • Platiblastin
  • Platiblastin-S
  • Platinex
  • Platinol- AQ
  • Platinol-AQ
  • Platinol-AQ VHA Plus
  • Platinoxan
  • Platinum
  • Platinum Diamminodichloride
  • Platiran
  • Platistin
  • Platosin
Given IV
Other Names:
  • Taxol
  • Anzatax
  • Asotax
  • Bristaxol
  • Praxel
  • Taxol Konzentrat
Experimental: Arm II (paclitaxel, cisplatin, bevacizumab)
Patients receive paclitaxel IV over 3 hours or 24 hours on day 1 and cisplatin IV and bevacizumab IV over 30-90 minutes on day 1 or 2.
Correlative studies
Ancillary studies
Other Names:
  • Quality of Life Assessment
Ancillary studies
Given IV
Other Names:
  • CDDP
  • Cis-diamminedichloridoplatinum
  • Cismaplat
  • Cisplatinum
  • Neoplatin
  • Platinol
  • Abiplatin
  • Blastolem
  • Briplatin
  • Cis-diammine-dichloroplatinum
  • Cis-diamminedichloro Platinum (II)
  • Cis-diamminedichloroplatinum
  • Cis-dichloroammine Platinum (II)
  • Cis-platinous Diamine Dichloride
  • Cis-platinum
  • Cis-platinum II
  • Cis-platinum II Diamine Dichloride
  • Cisplatina
  • Cisplatyl
  • Citoplatino
  • Citosin
  • Cysplatyna
  • DDP
  • Lederplatin
  • Metaplatin
  • Peyrone's Chloride
  • Peyrone's Salt
  • Placis
  • Plastistil
  • Platamine
  • Platiblastin
  • Platiblastin-S
  • Platinex
  • Platinol- AQ
  • Platinol-AQ
  • Platinol-AQ VHA Plus
  • Platinoxan
  • Platinum
  • Platinum Diamminodichloride
  • Platiran
  • Platistin
  • Platosin
Given IV
Other Names:
  • Taxol
  • Anzatax
  • Asotax
  • Bristaxol
  • Praxel
  • Taxol Konzentrat
Given IV
Other Names:
  • Avastin
  • Anti-VEGF
  • Anti-VEGF Humanized Monoclonal Antibody
  • Anti-VEGF rhuMAb
  • Immunoglobulin G1 (Human-Mouse Monoclonal rhuMab-VEGF Gamma-Chain Anti-Human Vascular Endothelial Growth Factor), Disulfide With Human-Mouse Monoclonal rhuMab-VEGF Light Chain, Dimer
  • Recombinant Humanized Anti-VEGF Monoclonal Antibody
  • rhuMab-VEGF
Experimental: Arm III (topotecan hydrochloride and paclitaxel)
Patients receive paclitaxel IV over 3 hours on day 1 and topotecan hydrochloride IV over 30 minutes on days 1-3.
Correlative studies
Ancillary studies
Other Names:
  • Quality of Life Assessment
Ancillary studies
Given IV
Other Names:
  • Taxol
  • Anzatax
  • Asotax
  • Bristaxol
  • Praxel
  • Taxol Konzentrat
Given IV
Other Names:
  • Hycamtin
  • Hycamptamine
  • SKF S-104864-A
  • Topotecan HCl
  • topotecan hydrochloride (oral)
Experimental: Arm IV (topotecan hydrochloride, paclitaxel, bevacizumab)
Patients receive paclitaxel IV over 3 hours and bevacizumab IV over 30-90 minutes on day 1 and topotecan hydrochloride IV over 30 minutes on days 1-3.
Correlative studies
Ancillary studies
Other Names:
  • Quality of Life Assessment
Ancillary studies
Given IV
Other Names:
  • Taxol
  • Anzatax
  • Asotax
  • Bristaxol
  • Praxel
  • Taxol Konzentrat
Given IV
Other Names:
  • Avastin
  • Anti-VEGF
  • Anti-VEGF Humanized Monoclonal Antibody
  • Anti-VEGF rhuMAb
  • Immunoglobulin G1 (Human-Mouse Monoclonal rhuMab-VEGF Gamma-Chain Anti-Human Vascular Endothelial Growth Factor), Disulfide With Human-Mouse Monoclonal rhuMab-VEGF Light Chain, Dimer
  • Recombinant Humanized Anti-VEGF Monoclonal Antibody
  • rhuMab-VEGF
Given IV
Other Names:
  • Hycamtin
  • Hycamptamine
  • SKF S-104864-A
  • Topotecan HCl
  • topotecan hydrochloride (oral)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: From entry into the study to death or the date of last contact, assessed up to 5 years
The observed length of life from randomization into the study to death or the date of last contact.
From entry into the study to death or the date of last contact, assessed up to 5 years
Progression-free Survival
Time Frame: From study entry until disease progression, death or date of last contact, assessed up to 5 years (During treatment: every 3 weeks if by physical exam, every 6 weeks by CXR, CT or MRI. In follow-up: quarterly for 2 years then semi-annually for 3 years)
Disease that can be assessed clinically (physical examination) should be evaluated every cycle (every 3 weeks). Disease assessed by imaging modalities (CXR, CT, MRI) should be evaluated every other cycle unless other evidence of a change mandates earlier assessment. Tumor measurements should also be done after the final cycle (if the patient is taken off of study therapy for a reason other than progression) and then every 3 months x 2 years (followed with every 6 months x 3 years) until progression is documented. "Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions assessed radiographically and 50% increase if the only target lesion is a solitary pelvic mass measured by physical exam, or unequivocal progression of a non-target lesion, or the appearance of new lesions", or similar definition as accurate and appropriate.
From study entry until disease progression, death or date of last contact, assessed up to 5 years (During treatment: every 3 weeks if by physical exam, every 6 weeks by CXR, CT or MRI. In follow-up: quarterly for 2 years then semi-annually for 3 years)
Tumor Response
Time Frame: Every cycle (if assessed by physical exam), every other cycle (if assessed by imaging), after the final cycle, then every 3 months x 2 years, then every 6 months x 3 years up to 5 years.
Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >= 30% decrease in the sum of the longest diameter of target lesions by CT, MRI or CXR. If the only target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% increase in longest diameter is required; Overall Response (OR) = CR + PR.
Every cycle (if assessed by physical exam), every other cycle (if assessed by imaging), after the final cycle, then every 3 months x 2 years, then every 6 months x 3 years up to 5 years.
To Determine and Compare the Frequency and Severity of Adverse Events as Assessed by CTCAE Version 3.0 for the Regimens Administered on This Study.
Time Frame: From date of enrollment until 30 days after treatment completion
The number of patients on each arm who have Grade 3 AE or higher toxicity.
From date of enrollment until 30 days after treatment completion

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Extent of Nicotine Dependence
Time Frame: Up to 5 years
Assessed from answers the patients provide to a questionnaire. Will be assessed for associations with progression and/or death.
Up to 5 years
Health-related Quality of Life
Time Frame: Up to 9 months after course 1
Assessed by FACT-Cx TOI; FACT/GOG-Ntx4 subscale; and BPI at baseline, before courses 2 and 5, and at 6 and 9 months after course 1. The linear mixed model will be used to evaluate the hypotheses on FACT-Cx TOI score, adjusting for baseline FACT-Cx TOI scores and age. A mixed-effects mixed-distribution model will be considered to analyze NTx4 subscale scores and the BPI score. 95% confidence intervals will be reported for the estimated treatment differences of BPI score.
Up to 9 months after course 1
Levels of Angiogenesis Markers in Plasma
Time Frame: Up to 5 years
Associations between biomarkers and overall survival or progression-free survival will be examined in a Cox proportional hazards model that includes significant prognostic variables based on prior research such as performance status, prior cisplatin therapy, and stage of disease. Logistic regression will be used to help assess the value of biomarkers in predicting response to a particular treatment or determine associations with response.
Up to 5 years
Levels of Cell-free DNA in Plasma
Time Frame: Up to 5 years
Associations between biomarkers and overall survival or progression-free survival will be examined in a Cox proportional hazards model that includes significant prognostic variables based on prior research such as performance status, prior cisplatin therapy, and stage of disease. Logistic regression will be used to help assess the value of biomarkers in predicting response to a particular treatment or determine associations with response.
Up to 5 years
Levels of Tumor Measures of Angiogenesis
Time Frame: Up to 5 years
Associations between biomarkers and overall survival or progression-free survival will be examined in a Cox proportional hazards model that includes significant prognostic variables based on prior research such as performance status, prior cisplatin therapy, and stage of disease. Logistic regression will be used to help assess the value of biomarkers in predicting response to a particular treatment or determine associations with response.
Up to 5 years
Number of CTCs
Time Frame: Up to 5 years
Associations between biomarkers and overall survival or progression-free survival will be examined in a Cox proportional hazards model that includes significant prognostic variables based on prior research such as performance status, prior cisplatin therapy, and stage of disease. Logistic regression will be used to help assess the value of biomarkers in predicting response to a particular treatment or determine associations with response.
Up to 5 years
Prevalence of Active Smoking
Time Frame: Up to 5 years
An estimate of the prevalence of active smoking will be calculated. Will be assessed for associations with progression and/or death.
Up to 5 years

Collaborators and Investigators

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

Collaborators

Investigators

  • Principal Investigator: Krishnansu Tewari, NRG Oncology

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

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

April 1, 2009

Primary Completion (Actual)

February 1, 2013

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

December 4, 2008

First Submitted That Met QC Criteria

December 4, 2008

First Posted (Estimate)

December 5, 2008

Study Record Updates

Last Update Posted (Actual)

July 23, 2019

Last Update Submitted That Met QC Criteria

July 19, 2019

Last Verified

July 1, 2019

More Information

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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