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Spots Global Cancer Trial Database for S0227 Cisplatin With Either Paclitaxel or Gemcitabine in Recurrent, Persistent, or Metastatic Cervical Cancer

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Trial Identification

Brief Title: S0227 Cisplatin With Either Paclitaxel or Gemcitabine in Recurrent, Persistent, or Metastatic Cervical Cancer

Official Title: Phase III Randomized Trial of Cisplatin/Paclitaxel Versus Cisplatin/Gemcitabine in Recurrent, Persistent or Metastatic Carcinoma of the Cervix

Study ID: NCT00057928

Conditions

Cervical Cancer

Study Description

Brief Summary: 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.

Detailed Description: OBJECTIVES: * Compare the overall survival, progression-free survival, and objective response rate (confirmed and unconfirmed, complete and partial) of patients with recurrent, persistent, or metastatic cervical cancer treated with cisplatin and paclitaxel vs cisplatin and gemcitabine. * Compare the toxicity of these regimens in these patients. 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

Minimum Age:

Eligible Ages: CHILD, ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

University of Alabama at Birmingham Comprehensive Cancer Center, Birmingham, Alabama, United States

MBCCOP - Gulf Coast, Mobile, Alabama, United States

CCOP - Greater Phoenix, Phoenix, Arizona, United States

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

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

Arizona Cancer Center, Tucson, Arizona, United States

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

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

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

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

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

Jonsson Comprehensive Cancer Center, UCLA, Los Angeles, California, United States

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

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

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

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

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

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

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

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

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

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

Mayo Clinic, Jacksonville, Florida, United States

CCOP - Atlanta Regional, Atlanta, Georgia, United States

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

Cancer Research Center of Hawaii, Honolulu, Hawaii, United States

Tripler Army Medical Center, Honolulu, Hawaii, United States

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

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

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

CCOP - Central Illinois, Decatur, Illinois, United States

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

Loyola University Medical Center, Maywood, Illinois, United States

University of Kansas Medical Center, Kansas City, Kansas, United States

CCOP - Wichita, Wichita, Kansas, United States

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

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

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

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

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

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

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

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

Boston Medical Center, Boston, Massachusetts, United States

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

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

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

University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States

Barbara Ann Karmanos Cancer Institute, Detroit, Michigan, United States

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

Henry Ford Hospital, Detroit, Michigan, United States

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

CCOP - Beaumont, Royal Oak, Michigan, United States

Providence Hospital - Southfield, Southfield, Michigan, United States

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

University of Mississippi Medical Center, Jackson, Mississippi, United States

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Barrett Cancer Center, Cincinnati, Ohio, United States

Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio, United States

CCOP - Columbus, Columbus, Ohio, United States

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

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

CCOP - Dayton, Dayton, Ohio, United States

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

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

Oregon Cancer Institute, Portland, Oregon, United States

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

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

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

Medical University of South Carolina, Charleston, South Carolina, United States

CCOP - Greenville, Greenville, South Carolina, United States

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

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

Brooke Army Medical Center, Fort Sam Houston, Texas, United States

University of Texas Medical Branch, Galveston, Texas, United States

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

Baylor College of Medicine, Houston, Texas, United States

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

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

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

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

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

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

Huntsman Cancer Institute, Salt Lake City, Utah, United States

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

Eastern Virginia Medical School, Norfolk, Virginia, United States

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

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

CCOP - Northwest, Tacoma, Washington, United States

Madigan Army Medical Center, Tacoma, Washington, United States

British Columbia Cancer Agency, Vancouver, British Columbia, Canada

Contact Details

Name: Harry J. Long, MD

Affiliation: Mayo Clinic

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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