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

This study is currently recruiting patients.

Sponsors and Collaborators: Gynecologic Oncology Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)

Purpose

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

MedlinePlus related topics:  Cancer;   Cancer Alternative Therapy;   Cervical Cancer;   Soft Tissue Sarcoma

Study Type: Interventional
Study Design: Treatment

Official Title: Phase III Randomized Study of Paclitaxel and Cisplatin Versus Vinorelbine and Cisplatin Versus Gemcitabine and Cisplatin Versus Topotecan and Cisplatin in Patients With Stage IVB, Recurrent, or Persistent Carcinoma of the Cervix

Further Study Details: 

OBJECTIVES:

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.

Eligibility

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

Endocrine therapy

  • Not specified

Radiotherapy

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

Surgery

  • Recovered from prior surgery

Location and Contact Information


Alabama
      University of Alabama at Birmingham Comprehensive Cancer Center, Birmingham,  Alabama,  35294-3300,  United States; Recruiting
Mack Barnes, MD  205-934-5077 

Arizona
      CCOP - Western Regional, Arizona, Phoenix,  Arizona,  85006-2726,  United States; Recruiting
David Kyle King, MD, FACP  602-239-2413    david.king@baannerhealth.com 

California
      Jonsson Comprehensive Cancer Center, UCLA, Los Angeles,  California,  90095-1740,  United States; Recruiting
Jonathan S. Berek, MD  310-206-5161 

      Women's Cancer Center - Los Gatos, Los Gatos,  California,  95032,  United States; Recruiting
Nick M. Spirtos, MD  408-866-3843    nspirtos@wccenter.com 

Colorado
      University of Colorado Cancer Center at University of Colorado Health Sciences Center, Denver,  Colorado,  80010,  United States; Recruiting
Francis J. Major, MD  303-388-4876    francis.major@usoncology.com 

Delaware
      CCOP - Christiana Care Health Services, Newark,  Delaware,  19713,  United States; Recruiting
Stephen Scott Grubbs, MD  302-623-4100 

Hawaii
      MBCCOP - Hawaii, Honolulu,  Hawaii,  96813,  United States; Recruiting
Brian F. Issell, MD  808-586-3015    brian@crch.hawaii.edu 

Illinois
      CCOP - Carle Cancer Center, Urbana,  Illinois,  61801,  United States; Recruiting
Kendrith M. Rowland, MD  217-383-4083    kendrith.rowland@carle.com 

      CCOP - Central Illinois, Decatur,  Illinois,  62794-9640,  United States; Recruiting
L. Stewart Massad, MD  217-545-8882 

      CCOP - Evanston, Evanston,  Illinois,  60201,  United States; Recruiting
Gershon Y. Locker, MD, FACP  847-570-2518    glocker@enh.org 

      MBCCOP - University of Illinois at Chicago, Chicago,  Illinois,  60612,  United States; Recruiting
Lawrence Eric Feldman, MD  312-335-3614 

      Rush University Medical Center, Chicago,  Illinois,  60612-3824,  United States; Recruiting
Howard T. Strassner, MD  312-942-6723 

      Hinsdale,  Illinois,  60521,  United States; Recruiting
Sudarshan K. Sharma, MD  630-856-6757    drsharma@ameritech.net 

      University of Chicago Cancer Research Center, Chicago,  Illinois,  60637-1470,  United States; Recruiting
Seiko Diane Yamada, MD  773-702-6722    sdyamada@babies.bsd.uchicago.edu 

Indiana
      Saint Joseph Regional Medical Center, South Bend,  Indiana,  46617,  United States; Recruiting
Michael W. Method, MD, MPH  574-237-8010    mmethod@mhopc.com 

Iowa
      Holden Comprehensive Cancer Center at University of Iowa, Iowa City,  Iowa,  52242-1002,  United States; Recruiting
Joel I. Sorosky, MD  319-356-2015    joel-sorosky@uiowa.edu 

Michigan
      CCOP - Grand Rapids, Grand Rapids,  Michigan,  49503,  United States; Recruiting
Kathleen Jo Yost, MD  616-391-1230 

      CCOP - Kalamazoo, Kalamazoo,  Michigan,  49007-3731,  United States; Recruiting
Raymond Sterling Lord, MD  269-373-7488    rlord@wmcc.org 

      CCOP - Michigan Cancer Research Consortium, Ann Arbor,  Michigan,  48106,  United States; Recruiting
Philip J. Stella, MD  734-712-5237    beekmanl@trinity-health.org 

Minnesota
      CCOP - Metro-Minnesota, Saint Louis Park,  Minnesota,  55416,  United States; Recruiting
Patrick J. Flynn, MD  952-993-1517    patrick.flynn@usoncology.com 

Mississippi
      Keesler Medical Center - Keesler Air Force Base, Keesler AFB,  Mississippi,  39534-2576,  United States; Recruiting
John Bomalaski, MD  228-377-6396    john.bomalaski@keesler.af.mil 

Missouri
      CCOP - Cancer Research for the Ozarks, Springfield,  Missouri,  65807,  United States; Recruiting
John Wendall Goodwin, MD  417-269-4520    jwg684@sprg.mercy.net 

      CCOP - Kansas City, Kansas City,  Missouri,  64131,  United States; Recruiting
William T. Stephenson, MD  816-823-0555 

Nebraska
      CCOP - Missouri Valley Cancer Consortium, Omaha,  Nebraska,  68106,  United States; Recruiting
James A. Mailliard, MD  402-280-4364    jamailliard@mrcc.cc 

New Jersey
      Cancer Institute of New Jersey at the Cooper University Hospital, Camden,  New Jersey,  08103-1489,  United States; Recruiting
David P. Warshal, MD  856-342-2185    warshal-david@cooperhealth.edu 

New York
      Long Island Cancer Center at Stony Brook University Hospital, Stony Brook,  New York,  11790-7775,  United States; Recruiting
Michael L. Pearl, MD  631-444-2774 

      Memorial Sloan-Kettering Cancer Center, New York,  New York,  10021,  United States; Recruiting
Carol L. Brown, MD  212-639-7659 

North Carolina
      Duke Comprehensive Cancer Center, Durham,  North Carolina,  27710,  United States; Recruiting
Daniel L. Clarke-Pearson, MD  919-684-3765 

      Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill, Chapel Hill,  North Carolina,  27599-7570,  United States; Recruiting
Wesley C. Fowler, MD  919-966-1196    wfowler@med.unc.edu 

Ohio
      Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University, Columbus,  Ohio,  43210-1240,  United States; Recruiting
Jeffrey McCabe Fowler, MD  614-293-8737 

      Charles M. Barrett Cancer Center at University Hospital, Cincinnati,  Ohio,  45267-0520,  United States; Recruiting
Nader Husseinzadeh, MD  513-558-8450    nallerhusseinzadeh@uc.edu 

      Cleveland Clinic Taussig Cancer Center, Cleveland,  Ohio,  44124,  United States; Recruiting
Peter Graham Rose, MD  216-444-1712    rosep@ccf.org 

      Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University, Cleveland,  Ohio,  44106,  United States; Recruiting
Steven E. Waggoner, MD  216-844-5011 

Oklahoma
      University of Oklahoma College of Medicine, Oklahoma City,  Oklahoma,  73104,  United States; Recruiting
Robert S. Mannel, MD  405-271-8787    robert-mannel@ouhsc.edu 

Oregon
      CCOP - Columbia River Oncology Program, Portland,  Oregon,  97225,  United States; Recruiting
Keith S. Lanier, MD  503-216-6260 

Pennsylvania
      Abington Memorial Hospital, Abington,  Pennsylvania,  19001-3788,  United States; Recruiting
Parviz Hanjani, MD  215-885-0220    phanjani@amh.org 

      Abramson Cancer Center at the University of Pennsylvania, Philadelphia,  Pennsylvania,  19104-4283,  United States; Recruiting
Mark A. Morgan, MD  215-662-6043 

      CCOP - Geisinger Clinic and Medical Center, Danville,  Pennsylvania,  17822-2001,  United States; Recruiting
Nava Siegelmann-Danieli, MD  570-271-6834    nsdanieli@geisinger.edu 

      UPMC Cancer Center at Magee-Womens Hospital, Pittsburgh,  Pennsylvania,  15213-3180,  United States; Recruiting
Joseph L. Kelley, MD  412-641-5418    jkelley@mail.magee.edu 

Tennessee
      Southeast Gynecologic Oncology Associates, Knoxville,  Tennessee,  37917,  United States; Recruiting
Kenneth F. Cofer, MD  865-673-9250 

      Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center, Nashville,  Tennessee,  37232-2516,  United States; Recruiting
Marta Ann Crispens, MD  615-322-2114    marta.crispens@vanderbilt.edu 

Texas
      CCOP - Scott and White Hospital, Temple,  Texas,  76508,  United States; Recruiting
Lucas Wong, MD  254-724-1053    lwong@swmail.sw.org 

      MD Anderson Cancer Center at University of Texas, Houston,  Texas,  77030-4009,  United States; Recruiting
Charles Levenback, MD  713-745-2563    clevenba@mdanderson.org 

      Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas, Dallas,  Texas,  75390-9032,  United States; Recruiting
David Scott Miller, MD  214-648-3026    david.miller@utsouthwestern.edu 

      University of Texas Medical Branch, Galveston,  Texas,  77555-0587,  United States; Recruiting
Edward V. Hannigan, MD  409-772-2368    ehanniga@utmb.edu 

Virginia
      Cancer Center at the University of Virginia, Charlottesville,  Virginia,  22908,  United States; Recruiting
Willie Albert Andersen, MD  434-924-9333 

Washington
      MultiCare Regional Cancer Center at Tacoma General Hospital, Tacoma,  Washington,  98405,  United States; Recruiting
Roger B. Lee, MD  253-403-1029    rogerblee@aol.com 

Wisconsin
      CCOP - Marshfield Clinic Research Foundation, Marshfield,  Wisconsin,  54449,  United States; Recruiting
Anthony Evans, MD, PhD  715-387-5161    evans.anthony@marshfieldclinic.org 

      University of Wisconsin Comprehensive Cancer Center, Madison,  Wisconsin,  53792-6188,  United States; Recruiting
Ellen Hartenbach, MD  608-263-1209 

Study chairs or principal investigators

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

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

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


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

Resources