Comparison of Four Combination Chemotherapy Regimens Using Cisplatin in Treating Patients With Stage IVB, Recurrent, or Persistent Cancer of the Cervix

This study has been completed.
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: July 8, 2003
Last updated: July 18, 2012
Last verified: April 2007

RATIONALE: Drugs used in chemotherapy such as cisplatin, paclitaxel, vinorelbine, gemcitabine, and topotecan, use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which combination chemotherapy regimen containing cisplatin is most effective in treating cervical cancer.

PURPOSE: This randomized phase III trial is studying four combination chemotherapy regimens using cisplatin to compare how well they work in treating women with stage IVB, recurrent, or persistent cancer of the cervix.

Condition Intervention Phase
Cervical Cancer
Drug: cisplatin
Drug: gemcitabine hydrochloride
Drug: paclitaxel
Drug: topotecan hydrochloride
Drug: vinorelbine tartrate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: A Randomized Phase III Trial Of Paclitaxel Plus Cisplatin Versus Vinorelbine Plus Cisplatin Versus Gemcitabine Plus Cisplatin Versus Topotecan Plus Cisplatin In Stage IVB, Recurrent Or Persistent Carcinoma of the Cervix

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Quality of life as measured by the FACT-Cervical Trial Outcome of Index and the FACT-Gynecologic Oncology Group/Neurotoxicity subscale at baseline, courses 2 and 5, and 9 months after completion of study treatment [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Brief Pain Inventory [ Designated as safety issue: No ]

Estimated Enrollment: 600
Study Start Date: July 2003
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Detailed Description:


  • Compare the survival and response of patients with stage IVB, recurrent, or persistent carcinoma of the cervix when treated with paclitaxel and cisplatin vs vinorelbine and cisplatin vs gemcitabine and cisplatin vs topotecan and cisplatin.
  • Compare the toxic effects of these regimens in these patients.
  • Compare the quality of life of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 4 treatment arms.

  • Arm I: Patients receive paclitaxel IV over 24 hours on day 1 and cisplatin IV over 1-4 hours on day 2.
  • Arm II: Patients receive vinorelbine IV over 6-10 minutes on days 1 and 8 and cisplatin IV over 1-4 hours on day 1.
  • Arm III: Patients receive gemcitabine IV over 30-60 minutes on days 1 and 8 and cisplatin as in arm II.
  • Arm IV: Patients receive topotecan IV over 30 minutes on days 1-3 and cisplatin as in arm II.

In all arms, treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, before courses 2 and 5, and at 9 months after study entry.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 600 patients (150 per treatment arm) will be accrued for this study within 4 years.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • Histologically confirmed squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix

    • Stage IVB, recurrent, or persistent disease
  • Not amenable to curative surgery and/or radiotherapy
  • At least 1 unidimensionally measurable lesion

    • At least 20 mm by palpation, plain x-ray, CT scan, or MRI OR at least 10 mm by spiral CT scan
    • Biopsy confirmation required if lesion is less than 30 mm
    • Target lesion must be outside of a previously irradiated field
  • No craniospinal metastases



  • 18 and over

Performance status

  • GOG 0-1

Life expectancy

  • Not specified


  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3


  • Bilirubin no greater than 1.5 times normal
  • Alkaline phosphatase no greater than 3 times normal
  • AST no greater than 3 times normal


  • Creatinine ≤ 1.2 mg/dL OR
  • Creatinine > 1.2 mg/dL but < 1.5 mg/dL AND creatinine clearance ≥ 50 mL/min
  • No bilateral hydronephrosis not alleviated by ureteral stents or percutaneous drainage


  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No prior or concurrent malignancy within the past 5 years except nonmelanoma skin cancer
  • No prior malignancy whose treatment contraindicates the current study therapy
  • No concurrent clinically significant infection


Biologic therapy

  • No concurrent cytokines


  • At least 6 weeks since prior chemoradiotherapy and recovered
  • No prior chemotherapy (except when concurrently administered with radiotherapy)

Endocrine therapy

  • Not specified


  • See Disease Characteristics
  • See Chemotherapy
  • At least 3 weeks since prior radiotherapy and recovered


  • Recovered from prior surgery
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Please refer to this study by its identifier: NCT00064077

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United States, Alabama
Lurleen Wallace Comprehensive Cancer at University of Alabama-Birmingham
Birmingham, Alabama, United States, 35294
United States, Arkansas
Highlands Oncology Group - Fayetteville
Fayetteville, Arkansas, United States, 72703
Washington Regional Medical Center
Fayetteville, Arkansas, United States, 72703
United States, California
Providence Saint Joseph Medical Center - Burbank
Burbank, California, United States, 91505
Moores UCSD Cancer Center
La Jolla, California, United States, 92093-0658
Todd Cancer Institute at Long Beach Memorial Medical Center
Long Beach, California, United States, 90801
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States, 90089-9181
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States, 90095-1781
Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
Orange, California, United States, 92868
University of California Davis Cancer Center
Sacramento, California, United States, 95817
UCSF Comprehensive Cancer Center
San Francisco, California, United States, 94115
Sansum Medical Clinic
Santa Barbara, California, United States, 93105
Santa Barbara Hematology Oncology Medical Group at Cancer Center of Santa Barbara
Santa Barbara, California, United States, 93105
Cancer Center of Santa Barbara
Snata Barbara, California, United States, 93105
Stanford Comprehensive Cancer Center - Stanford
Stanford, California, United States, 94305
Torrance Memorial Medical Center
Torrance, California, United States, 90509
United States, Colorado
Colorado Gynecologic Oncology Group P.C.
Aurora, Colorado, United States, 80010
United States, Connecticut
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
Hartford, Connecticut, United States, 06105
George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus
New Britain, Connecticut, United States, 06050
Yale Cancer Center
New Haven, Connecticut, United States, 06520-8028
United States, Delaware
CCOP - Christiana Care Health Services
Newark, Delaware, United States, 19713
United States, Florida
Mayo Clinic - Jacksonville
Jacksonville, Florida, United States, 32224
Ella Milbank Foshay Cancer Center at Jupiter Medical Center
Jupiter, Florida, United States, 33458
University of Miami Sylvester Comprehensive Cancer Center
Miami, Florida, United States, 33136
M.D. Anderson Cancer Center at Orlando
Orlando, Florida, United States, 32806
Florida Hospital Cancer Institute at Florida Hospital Orlando
Orlando, Florida, United States, 32803-1273
United States, Georgia
Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
Savannah, Georgia, United States, 31403-3089
United States, Illinois
Northwest Community Hospital
Arlington Heights, Illinois, United States, 60005
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States, 60611-3013
Rush University Medical Center
Chicago, Illinois, United States, 60612
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637-1470
Ingalls Cancer Care Center at Ingalls Memorial Hospital
Harvey, Illinois, United States, 60426
Hinsdale Hematology Oncology Associates
Hinsdale, Illinois, United States, 60521
Cardinal Bernardin Cancer Center at Loyola University Medical Center
Maywood, Illinois, United States, 60153
Chicago Gynecologic Oncology
Palatine, Illinois, United States, 60067
Regional Cancer Center at Memorial Medical Center
Springfield, Illinois, United States, 62781-0001
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St. Francis Hospital and Health Centers - Beech Grove Campus
Beech Grove, Indiana, United States, 46107
Elkhart General Hospital
Elkhart, Indiana, United States, 46515
Indiana University Cancer Center
Indianapolis, Indiana, United States, 46202-5289
Howard Community Hospital at Howard Regional Health System
Kokomo, Indiana, United States, 46904
Center for Cancer Therapy at LaPorte Hospital and Health Services
La Porte, Indiana, United States, 46350
Reid Hospital & Health Care Services, Incorporated
Richmond, Indiana, United States, 47374
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, United States, 46601
Memorial Hospital of South Bend
South Bend, Indiana, United States, 46601
United States, Iowa
Holden Comprehensive Cancer Center at University of Iowa
Iowa City, Iowa, United States, 52242
United States, Kentucky
Esther Marie Hatton Cancer Care Center at St. Elizabeth Medical Center
Edgewood, Kentucky, United States, 41017
James Graham Brown Cancer Center at University of Louisville
Louisville, Kentucky, United States, 40202
Louisville Oncology at Norton Cancer Center
Louisville, Kentucky, United States, 40202
United States, Louisiana
Woman's Hospital
Baton Rouge, Louisiana, United States, 70815
CCOP - Ochsner
New Orleans, Louisiana, United States, 70121
Ochsner Cancer Institute at Ochsner Clinic Foundation
New Orleans, Louisiana, United States, 70121
United States, Maryland
Greenebaum Cancer Center at University of Maryland Medical Center
Baltimore, Maryland, United States, 21201
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410
United States, Massachusetts
UMASS Memorial Cancer Center - University Campus
Worcester, Massachusetts, United States, 01655
United States, Michigan
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109-0942
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-1379
Hurley Medical Center
Flint, Michigan, United States, 48503
West Michigan Cancer Center
Kalamazoo, Michigan, United States, 49007-3731
Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph
St. Joseph, Michigan, United States, 49085
United States, Minnesota
Fairview Ridges Hospital
Burnsville, Minnesota, United States, 55337
Mercy and Unity Cancer Center at Mercy Hospital
Coon Rapids, Minnesota, United States, 55433
Fairview Southdale Hospital
Edina, Minnesota, United States, 55435
Mercy and Unity Cancer Center at Unity Hospital
Fridley, Minnesota, United States, 55432
Virginia Piper Cancer Institute at Abbott-Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
Hubert H. Humphrey Cancer Center at North Memorial Medical Center
Robbinsdale, Minnesota, United States, 55422-2900
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, United States, 55416
Park Nicollet Health Services
St. Louis Park, Minnesota, United States, 55416
United Hospital
St. Paul, Minnesota, United States, 55102
Ridgeview Medical Center
Waconia, Minnesota, United States, 55387
United States, Mississippi
St. Dominic Cancer Center
Jackson, Mississippi, United States, 39216
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
Regional Cancer Center at Singing River Hospital
Pascagoula, Mississippi, United States, 39581
United States, Missouri
CCOP - Kansas City
Kansas City, Missouri, United States, 64131
Hulston Cancer Center at Cox Medical Center South
Springfield, Missouri, United States, 65807
St. John's Regional Health Center
Springfield, Missouri, United States, 65804
United States, Nebraska
Methodist Estabrook Cancer Center
Omaha, Nebraska, United States, 68114
United States, Nevada
Women's Cancer Center - Lake Mead
Las Vegas, Nevada, United States, 89102
Saint Mary's Regional Medical Center
Reno, Nevada, United States, 89503
Washoe Cancer Services at Washoe Medical Center - Reno
Reno, Nevada, United States, 89502
United States, New Hampshire
Norris Cotton Cancer Center at Dartmouth - Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756-0002
United States, New Jersey
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
Marlton, New Jersey, United States, 08053
UMDNJ University Hospital
Newark, New Jersey, United States, 07103
Cancer Institute of New Jersey at Cooper - Voorhees
Voorhees, New Jersey, United States, 08043
Fox Chase Virtua Health Cancer Program at Virtua West Jersey
Voorhees, New Jersey, United States, 08043
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University of New Mexico Cancer Research and Treatment Center
Albuquerque, New Mexico, United States, 87131-5636
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New York Oncology Hematology, PC at Albany Medical Center
Albany, New York, United States, 12208
New York Oncology Hematology, PC at Albany Regional Cancer Care
Albany, New York, United States, 12206
SUNY Downstate Medical Center
Brooklyn, New York, United States, 11203
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
New York Oncology Hematology, PC - Hudson
Hudson, New York, United States, 12534
Queens Cancer Center of Queens Hospital
Jamaica, New York, United States, 11432
Don Monti Comprehensive Cancer Center at North Shore University Hospital
Manhasset, New York, United States, 11030
Long Island Jewish Medical Center
New Hyde Park, New York, United States, 11042
Mount Sinai Medical Center
New York, New York, United States, 10029
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Riverview Cancer Care Medical Associates, PC
Rexford, New York, United States, 12148
SUNY Upstate Medical University Hospital
Syracuse, New York, United States, 13210
Good Samaritan Hospital Medical Center
West Islip, New York, United States, 11795
United States, North Carolina
Hope A Women's Cancer Center
Asheville, North Carolina, United States, 28801
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States, 27599-7295
Presbyterian Cancer Center at Presbyterian Hospital
Charlotte, North Carolina, United States, 28233-3549
Blumenthal Cancer Center at Carolinas Medical Center
Charlotte, North Carolina, United States, 28232-2861
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710
Gynecologic Oncology Network
Greenville, North Carolina, United States, 27834
Leo W. Jenkins Cancer Center at ECU Medical School
Greenville, North Carolina, United States, 27835-6028
FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center
Pinehurst, North Carolina, United States, 28374
Piedmont Hematology-Oncology Associates
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
McDowell Cancer Center at Akron General Medical Center
Akron, Ohio, United States, 44307
Aultman Hospital Cancer Center at Aultman Health Foundation
Canton, Ohio, United States, 44710-1799
Good Samaritan Hospital Cancer Treatment Center
Cincinnati, Ohio, United States, 45220
Charles M. Barrett Cancer Center at University Hospital
Cincinnati, Ohio, United States, 45267
Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195
MetroHealth's Cancer Care Center at MetroHealth Medical Center
Cleveland, Ohio, United States, 44109
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
Columbus, Ohio, United States, 43210-1240
Mount Carmel Health - West Hospital
Columbus, Ohio, United States, 43222
Veterans Affairs Medical Center - Dayton
Dayton, Ohio, United States, 45428
David L. Rike Cancer Center at Miami Valley Hospital
Dayton, Ohio, United States, 45409
Good Samaritan Hospital
Dayton, Ohio, United States, 45406
CCOP - Dayton
Dayton, Ohio, United States, 45429
Samaritan North Cancer Care Center
Dayton, Ohio, United States, 45415
Grandview Hospital
Dayton, Ohio, United States, 45405
Blanchard Valley Medical Associates
Findlay, Ohio, United States, 45840
Charles F. Kettering Memorial Hospital
Kettering, Ohio, United States, 45429
Hillcrest Cancer Center at Hillcrest Hospital
Mayfield Heights, Ohio, United States, 44124
Middletown Regional Hospital
Middletown, Ohio, United States, 45044
UVMC Cancer Care Center at Upper Valley Medical Center
Troy, Ohio, United States, 45373-1300
United States Air Force Medical Center - Wright-Patterson
Wright-Patterson Afb, Ohio, United States, 45433-5529
Ruth G. McMillan Cancer Center at Greene Memorial Hospital
Xenia, Ohio, United States, 45385
United States, Oklahoma
Oklahoma University Cancer Institute
Oklahoma City, Oklahoma, United States, 73104
Cancer Care Associates - Midtown Tulsa
Tulsa, Oklahoma, United States, 74104
United States, Pennsylvania
Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
Allentown, Pennsylvania, United States, 18105
Penn State Cancer Institute at Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033-0850
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104-4283
Drexel University College of Medicine - Center City Hahnemann Campus
Philadelphia, Pennsylvania, United States, 19102
Fox Chase Cancer Center - Philadelphia
Philadelphia, Pennsylvania, United States, 19111-2497
Fox Chase Cancer Center CCOP Research Base
Philadelphia, Pennsylvania, United States, 19140
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, United States, 19107-5541
UPMC Cancer Center at Magee-Womens Hospital
Pittsburgh, Pennsylvania, United States, 15213
McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center
Reading, Pennsylvania, United States, 19612-6052
United States, Rhode Island
Women and Infants Hospital of Rhode Island
Providence, Rhode Island, United States, 02905
United States, South Carolina
Hollings Cancer Center at Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, South Dakota
Sioux Valley Hospital and University of South Dakota Medical Center
Sioux Falls, South Dakota, United States, 57117-5039
United States, Tennessee
East Tennessee State University Cancer Center at Johnson City Medical Center
Johnson City, Tennessee, United States, 37604
Baptist Regional Cancer Center at Baptist Hospital of East Tennessee
Knoxville, Tennessee, United States, 37901
Baptist Centers for Cancer Care
Memphis, Tennessee, United States, 38120
University of Tennessee College of Medicine
Memphis, Tennessee, United States, 38163
United States, Texas
Harrington Cancer Center
Amarillo, Texas, United States, 79106
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
Dallas, Texas, United States, 75390
University of Texas Medical Branch
Galveston, Texas, United States, 77555-0361
M.D. Anderson Cancer Center at University of Texas
Houston, Texas, United States, 77030-4009
UMC Southwest Cancer and Research Center
Lubbock, Texas, United States, 79415-3364
CCOP - Scott and White Hospital
Temple, Texas, United States, 76508
United States, Utah
American Fork Hospital
American Fork, Utah, United States, 84003
Logan Regional Hospital
Logan, Utah, United States, 84321
Cottonwood Hospital Medical Center
Murray, Utah, United States, 84107
McKay-Dee Hospital Center
Ogden, Utah, United States, 84403
Utah Valley Regional Medical Center - Provo
Provo, Utah, United States, 84604
Dixie Regional Medical Center - East Campus
Saint George, Utah, United States, 84770
Latter Day Saints Hospital
Salt Lake City, Utah, United States, 84103
Utah Cancer Specialists at UCS Cancer Center
Salt Lake City, Utah, United States, 84106
United States, Virginia
University of Virginia Cancer Center at UV Health System
Charlottesville, Virginia, United States, 22908
Virginia Oncology Associates - Hampton
Hampton, Virginia, United States, 23666
Virginia Oncology Associates - Lake Wright
Norfolk, Virginia, United States, 23502
Bon Secours Cancer Institute at St. Mary's Hospital
Richmond, Virginia, United States, 23226
Virginia Commonwealth University Massey Cancer Center
Richmond, Virginia, United States, 23298-0037
Carilion Gynecologic Oncology Associates
Roanoke, Virginia, United States, 24014
United States, Washington
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98104
MultiCare Regional Cancer Center at Tacoma General Hospital
Tacoma, Washington, United States, 98405
United States, Wisconsin
Marshfield Clinic - Marshfield Center
Marshfield, Wisconsin, United States, 54449
Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Gynecologic Oncology Group
Study Chair: Bradley J. Monk, MD Chao Family Comprehensive Cancer Center
  More Information

Additional Information:
Monk BJ, Sill M, McMeekin DS, et al.: A randomized phase III trial of four cisplatin (CIS) containing doublet combinations in stage IVB, recurrent or persistent cervical carcinoma: a Gynecologic Oncology Group (GOG) study. [Abstract] J Clin Oncol 26 (Suppl 15): A-LBA5504, 2008.
Wenzel LB, Huang H, Cella D, et al.: Quality-of-life results of a randomized phase III trial of four cisplatin (Cis) containing doublet combinations in stage IVB cervical carcinoma: A gynecologic oncology group (GOG) study. [Abstract] J Clin Oncol 26 (Suppl 15): A-5529, 2008. Identifier: NCT00064077     History of Changes
Other Study ID Numbers: CDR0000306463, GOG-0204
Study First Received: July 8, 2003
Last Updated: July 18, 2012
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
cervical adenocarcinoma
cervical adenosquamous cell carcinoma
cervical squamous cell carcinoma
recurrent cervical cancer
stage IVB cervical cancer

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Genital Diseases, Female
Genital Neoplasms, Female
Neoplasms by Site
Urogenital Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Uterine Neoplasms
Anti-Infective Agents
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Antiviral Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Therapeutic Uses
Topoisomerase I Inhibitors
Topoisomerase Inhibitors processed this record on April 23, 2015