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: Randomized phase III trial to compare the effectiveness of four combination chemotherapy regimens using cisplatin in treating women who have stage IVB, recurrent, or persistent cancer of the cervix.

Condition	Treatment or Intervention	Phase
cervical adenocarcinoma cervical adenosquamous cell carcinoma cervical squamous cell carcinoma recurrent cervical cancer stage IVB cervical cancer	Drug: cisplatin  Drug: gemcitabine  Drug: paclitaxel  Drug: topotecan  Drug: vinorelbine  Procedure: chemotherapy	Phase III

Further Study Details: 

OBJECTIVES:

• 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 above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

• 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

PATIENT CHARACTERISTICS: Age

• 18 and over

Performance status

• GOG 0-1

Life expectancy

• Not specified

Hematopoietic

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

Hepatic

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

Renal

• Creatinine no greater than 1.2 mg/dL OR
• Creatinine greater than 1.2 mg/dL but less than 1.5 mg/dL AND creatinine clearance greater than 50 mL/min
• No bilateral hydronephrosis not alleviated by ureteral stents or percutaneous drainage

Other

• 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

PRIOR CONCURRENT THERAPY: Biologic therapy

• No concurrent cytokines

Chemotherapy

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

Endocrine therapy

• Not specified

Radiotherapy

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

Surgery

• Recovered from prior surgery

Alabama
      University of Alabama at Birmingham Comprehensive Cancer Center, Birmingham,  Alabama,  35294-3300,  United States; Recruiting
Arizona
      CCOP - Western Regional, Arizona, Phoenix,  Arizona,  85006-2726,  United States; Recruiting
California
      Jonsson Comprehensive Cancer Center, UCLA, Los Angeles,  California,  90095-1740,  United States; Recruiting
      Women's Cancer Center - Los Gatos, Los Gatos,  California,  95032,  United States; Recruiting
Colorado
      University of Colorado Cancer Center at University of Colorado Health Sciences Center, Denver,  Colorado,  80010,  United States; Recruiting
Delaware
      CCOP - Christiana Care Health Services, Newark,  Delaware,  19713,  United States; Recruiting
Hawaii
      MBCCOP - Hawaii, Honolulu,  Hawaii,  96813,  United States; Recruiting
Illinois
      CCOP - Carle Cancer Center, Urbana,  Illinois,  61801,  United States; Recruiting
      CCOP - Central Illinois, Decatur,  Illinois,  62794-9640,  United States; Recruiting
      CCOP - Evanston, Evanston,  Illinois,  60201,  United States; Recruiting
      MBCCOP - University of Illinois at Chicago, Chicago,  Illinois,  60612,  United States; Recruiting
      Rush University Medical Center, Chicago,  Illinois,  60612-3824,  United States; Recruiting
      Hinsdale,  Illinois,  60521,  United States; Recruiting
      University of Chicago Cancer Research Center, Chicago,  Illinois,  60637-1470,  United States; Recruiting
Indiana
      Saint Joseph Regional Medical Center, South Bend,  Indiana,  46617,  United States; Recruiting
Iowa
      Holden Comprehensive Cancer Center at University of Iowa, Iowa City,  Iowa,  52242-1002,  United States; Recruiting
Michigan
      CCOP - Grand Rapids, Grand Rapids,  Michigan,  49503,  United States; Recruiting
      CCOP - Kalamazoo, Kalamazoo,  Michigan,  49007-3731,  United States; Recruiting
      CCOP - Michigan Cancer Research Consortium, Ann Arbor,  Michigan,  48106,  United States; Recruiting
Minnesota
      CCOP - Metro-Minnesota, Saint Louis Park,  Minnesota,  55416,  United States; Recruiting
Mississippi
      Keesler Medical Center - Keesler Air Force Base, Keesler AFB,  Mississippi,  39534-2576,  United States; Recruiting
Missouri
      CCOP - Cancer Research for the Ozarks, Springfield,  Missouri,  65807,  United States; Recruiting
      CCOP - Kansas City, Kansas City,  Missouri,  64131,  United States; Recruiting
Nebraska
      CCOP - Missouri Valley Cancer Consortium, Omaha,  Nebraska,  68106,  United States; Recruiting
New Jersey
      Cancer Institute of New Jersey at the Cooper University Hospital, Camden,  New Jersey,  08103-1489,  United States; Recruiting
New York
      Long Island Cancer Center at Stony Brook University Hospital, Stony Brook,  New York,  11790-7775,  United States; Recruiting
      Memorial Sloan-Kettering Cancer Center, New York,  New York,  10021,  United States; Recruiting
North Carolina
      Duke Comprehensive Cancer Center, Durham,  North Carolina,  27710,  United States; Recruiting
      Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill, Chapel Hill,  North Carolina,  27599-7570,  United States; Recruiting
Ohio
      Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University, Columbus,  Ohio,  43210-1240,  United States; Recruiting
      Charles M. Barrett Cancer Center at University Hospital, Cincinnati,  Ohio,  45267-0520,  United States; Recruiting
      Cleveland Clinic Taussig Cancer Center, Cleveland,  Ohio,  44124,  United States; Recruiting
      Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University, Cleveland,  Ohio,  44106,  United States; Recruiting
Oklahoma
      University of Oklahoma College of Medicine, Oklahoma City,  Oklahoma,  73104,  United States; Recruiting
Oregon
      CCOP - Columbia River Oncology Program, Portland,  Oregon,  97225,  United States; Recruiting
Pennsylvania
      Abington Memorial Hospital, Abington,  Pennsylvania,  19001-3788,  United States; Recruiting
      Abramson Cancer Center at the University of Pennsylvania, Philadelphia,  Pennsylvania,  19104-4283,  United States; Recruiting
      CCOP - Geisinger Clinic and Medical Center, Danville,  Pennsylvania,  17822-2001,  United States; Recruiting
      UPMC Cancer Center at Magee-Womens Hospital, Pittsburgh,  Pennsylvania,  15213-3180,  United States; Recruiting
Tennessee
      Southeast Gynecologic Oncology Associates, Knoxville,  Tennessee,  37917,  United States; Recruiting
      Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center, Nashville,  Tennessee,  37232-2516,  United States; Recruiting
Texas
      CCOP - Scott and White Hospital, Temple,  Texas,  76508,  United States; Recruiting
      MD Anderson Cancer Center at University of Texas, Houston,  Texas,  77030-4009,  United States; Recruiting
      Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas, Dallas,  Texas,  75390-9032,  United States; Recruiting
      University of Texas Medical Branch, Galveston,  Texas,  77555-0587,  United States; Recruiting
Virginia
      Cancer Center at the University of Virginia, Charlottesville,  Virginia,  22908,  United States; Recruiting
Washington
      MultiCare Regional Cancer Center at Tacoma General Hospital, Tacoma,  Washington,  98405,  United States; Recruiting
Wisconsin
      CCOP - Marshfield Clinic Research Foundation, Marshfield,  Wisconsin,  54449,  United States; Recruiting
      University of Wisconsin Comprehensive Cancer Center, Madison,  Wisconsin,  53792-6188,  United States; Recruiting

Study chairs or principal investigators

Bradley J. Monk, MD,  Study Chair,  Chao Family Comprehensive Cancer Center   

Study ID Numbers:  CDR0000306463; GOG-0204; NCT00064077
Record last reviewed:  February 2005
Last Updated:  April 4, 2005
Record first received:  July 8, 2003
ClinicalTrials.gov Identifier:  NCT00064077
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08