Clinical Trial: Comparison of Cisplatin Combined With Either Paclitaxel or Gemcitabine in Treating Patients With Recurrent, Persistent, or Metastatic Cervical Cancer

This study is no longer recruiting patients.

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

Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known whether cisplatin is more effective when combined with paclitaxel or gemcitabine in treating cervical cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of cisplatin combined with paclitaxel to that of cisplatin combined with gemcitabine in treating women who have recurrent, persistent, or metastatic cervical cancer.

Condition Treatment or Intervention Phase
recurrent cervical cancer
stage IVB cervical cancer
 Drug: cisplatin
 Drug: gemcitabine
 Drug: paclitaxel
 Procedure: chemotherapy
Phase III

MedlinePlus related topics:  Cervical Cancer

Study Type: Interventional
Study Design: Treatment

Official Title: Phase III Randomized Study of Cisplatin and Paclitaxel Versus Cisplatin and Gemcitabine in Patients With Recurrent, Persistent, or Metastatic Cervical Cancer

Further Study Details: 

OBJECTIVES:

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to disease status at study entry (metastatic vs recurrent vs persistent), prior cisplatin as a radiosensitizer (yes vs no), and extent of disease (confined to pelvis vs extrapelvic disease). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive paclitaxel IV over 24 hours on day 1 and cisplatin IV over 2 hours on day 2.
  • Arm II: Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and cisplatin IV over 2 hours on day 1. In both arms, treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

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

PROJECTED ACCRUAL: A total of 500 patients (250 per treatment arm) will be accrued for this study within 4 years.

Eligibility

Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of primary carcinoma of the cervix, meeting 1 of the following staging criteria:
  • Metastatic (stage IVB)
  • Recurrent after prior complete response to primary treatment with surgery or radiotherapy
  • Persistent after surgery or radiotherapy
  • Measurable disease

PATIENT CHARACTERISTICS: Age

  • Not specified

Performance status

  • Zubrod 0-1

Life expectancy

  • Not specified

Hematopoietic

  • Not specified

Hepatic

  • Not specified

Renal

  • Creatinine less than upper limit of normal OR
  • Creatinine clearance greater than 40 mL/min

Other

PRIOR CONCURRENT THERAPY: Biologic therapy

  • Not specified

Chemotherapy

  • More than 6 months since prior single-agent chemotherapy as a radiosensitizer

Endocrine therapy

  • Not specified

Radiotherapy

  • See Disease Characteristics
  • At least 28 days since prior radiotherapy
  • No prior radiotherapy to measurable target lesions
  • No concurrent palliative radiotherapy

Surgery

  • See Disease Characteristics
  • Recovered from prior surgery

Other

  • No prior systemic therapy
  • No other concurrent antitumor therapy

Location Information


Alabama
      MBCCOP - Gulf Coast, Mobile,  Alabama,  36688,  United States

      University of Alabama at Birmingham Comprehensive Cancer Center, Birmingham,  Alabama,  35294-3300,  United States

Arizona
      Arizona Cancer Center, Tucson,  Arizona,  85724,  United States

      CCOP - Greater Phoenix, Phoenix,  Arizona,  85006-2726,  United States

      Veterans Affairs Medical Center - Phoenix (Carl T. Hayden), Phoenix,  Arizona,  85012,  United States

      Veterans Affairs Medical Center - Tucson, Tucson,  Arizona,  85723,  United States

Arkansas
      University of Arkansas for Medical Sciences, Little Rock,  Arkansas,  72205,  United States

      Veterans Affairs Medical Center - Little Rock (McClellan), Little Rock,  Arkansas,  72205,  United States

California
      CCOP - Bay Area Tumor Institute, Oakland,  California,  94609-3305,  United States

      CCOP - Santa Rosa Memorial Hospital, Santa Rosa,  California,  95403,  United States

      Chao Family Comprehensive Cancer Center, Orange,  California,  92868,  United States

      City of Hope Comprehensive Cancer Center, Duarte,  California,  91010,  United States

      David Grant Medical Center, Travis Air Force Base,  California,  94535,  United States

      Jonsson Comprehensive Cancer Center, UCLA, Los Angeles,  California,  90095-1781,  United States

      University of California Davis Cancer Center, Sacramento,  California,  95817,  United States

      USC/Norris Comprehensive Cancer Center and Hospital, Los Angeles,  California,  90033-0804,  United States

      Veterans Affairs Medical Center - San Francisco, San Francisco,  California,  94121,  United States

      Veterans Affairs Medical Center - West Los Angeles, Los Angeles,  California,  90073,  United States

      Veterans Affairs Outpatient Clinic - Martinez, Martinez,  California,  94553,  United States

Colorado
      University of Colorado Cancer Center, Denver,  Colorado,  80010,  United States

      Veterans Affairs Medical Center - Denver, Denver,  Colorado,  80220,  United States

District of Columbia
      MBCCOP - Howard University Cancer Center, Washington,  District of Columbia,  20060,  United States

Florida
      Mayo Clinic, Jacksonville,  Florida,  32224,  United States

Georgia
      CCOP - Atlanta Regional, Atlanta,  Georgia,  30342-1701,  United States

      Dwight David Eisenhower Army Medical Center, Fort Gordon,  Georgia,  30905-5650,  United States

Hawaii
      Cancer Research Center of Hawaii, Honolulu,  Hawaii,  96813-2424,  United States

      Tripler Army Medical Center, Honolulu,  Hawaii,  96859-5000,  United States

Illinois
      CCOP - Central Illinois, Decatur,  Illinois,  62526,  United States

      Loyola University Medical Center, Maywood,  Illinois,  60153-5500,  United States

      MBCCOP - University of Illinois at Chicago, Chicago,  Illinois,  60612-7323,  United States

      Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago,  Illinois,  60611-W227,  United States

      Veterans Affairs Medical Center - Chicago (Westside Hospital), Chicago,  Illinois,  60612,  United States

      Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital), Hines,  Illinois,  60141,  United States

Kansas
      CCOP - Wichita, Wichita,  Kansas,  67214-3882,  United States

      University of Kansas Medical Center, Kansas City,  Kansas,  66160-7353,  United States

      Veterans Affairs Medical Center - Wichita, Wichita,  Kansas,  67218,  United States

Kentucky
      Albert B. Chandler Medical Center, University of Kentucky, Lexington,  Kentucky,  40536-0084,  United States

      Veterans Affairs Medical Center - Lexington, Lexington,  Kentucky,  40502-2236,  United States

Louisiana
      Louisiana State University Health Sciences Center - Shreveport, Shreveport,  Louisiana,  71130-3932,  United States

      MBCCOP - LSU Health Sciences Center, New Orleans,  Louisiana,  70112,  United States

      Tulane University School of Medicine, New Orleans,  Louisiana,  70112,  United States

      Veterans Affairs Medical Center - New Orleans, New Orleans,  Louisiana,  70112,  United States

      Veterans Affairs Medical Center - Shreveport, Shreveport,  Louisiana,  71130,  United States

Massachusetts
      Boston Medical Center, Boston,  Massachusetts,  02118,  United States

      Veterans Affairs Medical Center - Boston (Jamaica Plain), Jamaica Plain,  Massachusetts,  02130,  United States

Michigan
      Barbara Ann Karmanos Cancer Institute, Detroit,  Michigan,  48201-1379,  United States

      CCOP - Beaumont, Royal Oak,  Michigan,  48073-6769,  United States

      CCOP - Grand Rapids, Grand Rapids,  Michigan,  49503,  United States

      CCOP - Michigan Cancer Research Consortium, Ann Arbor,  Michigan,  48106,  United States

      Henry Ford Hospital, Detroit,  Michigan,  48202,  United States

      Providence Hospital - Southfield, Southfield,  Michigan,  48075-9975,  United States

      University of Michigan Comprehensive Cancer Center, Ann Arbor,  Michigan,  48109-0912,  United States

      Veterans Affairs Medical Center - Ann Arbor, Ann Arbor,  Michigan,  48105,  United States

      Veterans Affairs Medical Center - Detroit, Detroit,  Michigan,  48201-1932,  United States

Mississippi
      Keesler Medical Center - Keesler AFB, Keesler AFB,  Mississippi,  39534-2576,  United States

      University of Mississippi Medical Center, Jackson,  Mississippi,  39216-4505,  United States

      Veterans Affairs Medical Center - Biloxi, Biloxi,  Mississippi,  39531-2410,  United States

      Veterans Affairs Medical Center - Jackson, Jackson,  Mississippi,  39216,  United States

Missouri
      CCOP - Cancer Research for the Ozarks, Springfield,  Missouri,  65807,  United States

      CCOP - Kansas City, Kansas City,  Missouri,  64131,  United States

      CCOP - St. Louis-Cape Girardeau, Saint Louis,  Missouri,  63141,  United States

      St. Louis University Health Sciences Center, Saint Louis,  Missouri,  63110,  United States

      Veterans Affairs Medical Center - Kansas City, Kansas City,  Missouri,  64128,  United States

Montana
      CCOP - Montana Cancer Consortium, Billings,  Montana,  59101,  United States

New Mexico
      MBCCOP - University of New Mexico HSC, Albuquerque,  New Mexico,  87131,  United States

      Veterans Affairs Medical Center - Albuquerque, Albuquerque,  New Mexico,  87108-5138,  United States

New York
      Herbert Irving Comprehensive Cancer Center, New York,  New York,  10032,  United States

      James P. Wilmot Cancer Center at the University of Rochester Medical Center, Rochester,  New York,  14642,  United States

      Veterans Affairs Medical Center - Albany, Albany,  New York,  12208,  United States

      Western New York Urology Associates, Buffalo,  New York,  14220,  United States

North Carolina
      CCOP - Southeast Cancer Control Consortium, Winston Salem,  North Carolina,  27104-4241,  United States

Ohio
      Arthur G. James Cancer Hospital - Ohio State University, Columbus,  Ohio,  43210-1240,  United States

      Barrett Cancer Center, Cincinnati,  Ohio,  45267-0501,  United States

      CCOP - Columbus, Columbus,  Ohio,  43206,  United States

      CCOP - Dayton, Dayton,  Ohio,  45429,  United States

      Cleveland Clinic Taussig Cancer Center, Cleveland,  Ohio,  44195-9001,  United States

      Veterans Affairs Medical Center - Cincinnati, Cincinnati,  Ohio,  45220-2288,  United States

      Veterans Affairs Medical Center - Dayton, Dayton,  Ohio,  45428,  United States

Oklahoma
      University of Oklahoma Health Sciences Center, Oklahoma City,  Oklahoma,  73104,  United States

      Veterans Affairs Medical Center - Oklahoma City, Oklahoma City,  Oklahoma,  73104,  United States

Oregon
      CCOP - Columbia River Program, Portland,  Oregon,  97225,  United States

      Oregon Cancer Institute, Portland,  Oregon,  97201-3098,  United States

      Veterans Affairs Medical Center - Portland, Portland,  Oregon,  97207,  United States

South Carolina
      CCOP - Greenville, Greenville,  South Carolina,  29615,  United States

      CCOP - Upstate Carolina, Spartanburg,  South Carolina,  29303,  United States

      Medical University of South Carolina, Charleston,  South Carolina,  29425-0721,  United States

      Veterans Affairs Medical Center - Charleston, Charleston,  South Carolina,  29401-5799,  United States

Tennessee
      University of Tennessee Cancer Institute, Memphis,  Tennessee,  38103,  United States

Texas
      Baylor College of Medicine, Houston,  Texas,  77030,  United States

      Brooke Army Medical Center, Fort Sam Houston,  Texas,  78234-6200,  United States

      CCOP - Scott and White Hospital, Temple,  Texas,  76508,  United States

      Texas Tech University Health Science Center, Lubbock,  Texas,  79415,  United States

      University of Texas - MD Anderson Cancer Center, Houston,  Texas,  77030-4095,  United States

      University of Texas Health Science Center at San Antonio, San Antonio,  Texas,  78229-3900,  United States

      University of Texas Medical Branch, Galveston,  Texas,  77555-0565,  United States

      Veterans Affairs Medical Center - Houston, Houston,  Texas,  77030,  United States

      Veterans Affairs Medical Center - San Antonio (Murphy), San Antonio,  Texas,  78229,  United States

      Veterans Affairs Medical Center - Temple, Temple,  Texas,  76504,  United States

Utah
      Huntsman Cancer Institute, Salt Lake City,  Utah,  84112-5550,  United States

      Veterans Affairs Medical Center - Salt Lake City, Salt Lake City,  Utah,  84148,  United States

Virginia
      Eastern Virginia Medical School, Norfolk,  Virginia,  23510-1115,  United States

Washington
      CCOP - Northwest, Tacoma,  Washington,  98405-0986,  United States

      CCOP - Virginia Mason Research Center, Seattle,  Washington,  98101,  United States

      Madigan Army Medical Center, Tacoma,  Washington,  98431-5000,  United States

      Veterans Affairs Medical Center - Seattle, Seattle,  Washington,  98108,  United States

Canada, British Columbia
      British Columbia Cancer Agency, Vancouver,  British Columbia,  V5Z 4E6,  Canada

Study chairs or principal investigators

Harry J. Long, MD,  Study Chair,  Mayo Clinic Cancer Center   

More Information

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

Study ID Numbers:  CDR0000285630; SWOG-S0227
Record last reviewed:  September 2003
Last Updated:  October 13, 2004
Record first received:  April 7, 2003
ClinicalTrials.gov Identifier:  NCT00057928
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08


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

Resources