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

Last updated: June 11, 2012
Sponsor: Southwest Oncology Group
Overall Status: Trial Not Available

Phase

3

Condition

Dysfunctional Uterine Bleeding

Uterine Disorders

Cervical Cancer

Treatment

N/A

Clinical Study ID

NCT00057928
CDR0000285630
U10CA032102
S0227
  • Female

Study 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.

Eligibility Criteria

Inclusion

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

  • Not pregnant or nursing

  • Fertile patients must use effective contraception

  • No grade 2 or greater sensory or motor neuropathy

  • No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer currently in complete remission

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

Study Design

Study Start date:
April 01, 2003
Estimated Completion Date:
July 31, 2003

Study 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.

Connect with a study center

  • British Columbia Cancer Agency

    Vancouver, British Columbia V5Z 4E6
    Canada

    Site Not Available

  • University of Alabama at Birmingham Comprehensive Cancer Center

    Birmingham, Alabama 35294-3300
    United States

    Site Not Available

  • MBCCOP - Gulf Coast

    Mobile, Alabama 36688
    United States

    Site Not Available

  • CCOP - Greater Phoenix

    Phoenix, Arizona 85006-2726
    United States

    Site Not Available

  • Veterans Affairs Medical Center - Phoenix (Carl T. Hayden)

    Phoenix, Arizona 85012
    United States

    Site Not Available

  • Arizona Cancer Center

    Tucson, Arizona 85724
    United States

    Site Not Available

  • Veterans Affairs Medical Center - Tucson

    Tucson, Arizona 85723
    United States

    Site Not Available

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas 72205
    United States

    Site Not Available

  • Veterans Affairs Medical Center - Little Rock (McClellan)

    Little Rock, Arkansas 72205
    United States

    Site Not Available

  • City of Hope Comprehensive Cancer Center

    Duarte, California 91010
    United States

    Site Not Available

  • Jonsson Comprehensive Cancer Center, UCLA

    Los Angeles, California 90095-1781
    United States

    Site Not Available

  • USC/Norris Comprehensive Cancer Center and Hospital

    Los Angeles, California 90033-0804
    United States

    Site Not Available

  • Veterans Affairs Medical Center - West Los Angeles

    Los Angeles, California 90073
    United States

    Site Not Available

  • Veterans Affairs Outpatient Clinic - Martinez

    Martinez, California 94553
    United States

    Site Not Available

  • CCOP - Bay Area Tumor Institute

    Oakland, California 94609-3305
    United States

    Site Not Available

  • Chao Family Comprehensive Cancer Center

    Orange, California 92868
    United States

    Site Not Available

  • University of California Davis Cancer Center

    Sacramento, California 95817
    United States

    Site Not Available

  • Veterans Affairs Medical Center - San Francisco

    San Francisco, California 94121
    United States

    Site Not Available

  • CCOP - Santa Rosa Memorial Hospital

    Santa Rosa, California 95403
    United States

    Site Not Available

  • David Grant Medical Center

    Travis Air Force Base, California 94535
    United States

    Site Not Available

  • University of Colorado Cancer Center

    Denver, Colorado 80010
    United States

    Site Not Available

  • Veterans Affairs Medical Center - Denver

    Denver, Colorado 80220
    United States

    Site Not Available

  • MBCCOP - Howard University Cancer Center

    Washington, District of Columbia 20060
    United States

    Site Not Available

  • Mayo Clinic

    Jacksonville, Florida 32224
    United States

    Site Not Available

  • CCOP - Atlanta Regional

    Atlanta, Georgia 30342-1701
    United States

    Site Not Available

  • Dwight David Eisenhower Army Medical Center

    Fort Gordon, Georgia 30905-5650
    United States

    Site Not Available

  • Cancer Research Center of Hawaii

    Honolulu, Hawaii 96813-2424
    United States

    Site Not Available

  • Tripler Army Medical Center

    Honolulu, Hawaii 96859-5000
    United States

    Site Not Available

  • MBCCOP - University of Illinois at Chicago

    Chicago, Illinois 60612-7323
    United States

    Site Not Available

  • Robert H. Lurie Comprehensive Cancer Center, Northwestern University

    Chicago, Illinois 60611-W227
    United States

    Site Not Available

  • Veterans Affairs Medical Center - Chicago (Westside Hospital)

    Chicago, Illinois 60612
    United States

    Site Not Available

  • CCOP - Central Illinois

    Decatur, Illinois 62526
    United States

    Site Not Available

  • Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)

    Hines, Illinois 60141
    United States

    Site Not Available

  • Loyola University Medical Center

    Maywood, Illinois 60153-5500
    United States

    Site Not Available

  • University of Kansas Medical Center

    Kansas City, Kansas 66160-7353
    United States

    Site Not Available

  • CCOP - Wichita

    Wichita, Kansas 67214-3882
    United States

    Site Not Available

  • Veterans Affairs Medical Center - Wichita

    Wichita, Kansas 67218
    United States

    Site Not Available

  • Albert B. Chandler Medical Center, University of Kentucky

    Lexington, Kentucky 40536-0084
    United States

    Site Not Available

  • Veterans Affairs Medical Center - Lexington

    Lexington, Kentucky 40502-2236
    United States

    Site Not Available

  • MBCCOP - LSU Health Sciences Center

    New Orleans, Louisiana 70112
    United States

    Site Not Available

  • Tulane University School of Medicine

    New Orleans, Louisiana 70112
    United States

    Site Not Available

  • Veterans Affairs Medical Center - New Orleans

    New Orleans, Louisiana 70112
    United States

    Site Not Available

  • Louisiana State University Health Sciences Center - Shreveport

    Shreveport, Louisiana 71130-3932
    United States

    Site Not Available

  • Veterans Affairs Medical Center - Shreveport

    Shreveport, Louisiana 71130
    United States

    Site Not Available

  • Boston Medical Center

    Boston, Massachusetts 02118
    United States

    Site Not Available

  • Veterans Affairs Medical Center - Boston (Jamaica Plain)

    Jamaica Plain, Massachusetts 02130
    United States

    Site Not Available

  • CCOP - Michigan Cancer Research Consortium

    Ann Arbor, Michigan 48106
    United States

    Site Not Available

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan 48109-0912
    United States

    Site Not Available

  • Veterans Affairs Medical Center - Ann Arbor

    Ann Arbor, Michigan 48105
    United States

    Site Not Available

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan 48201-1379
    United States

    Site Not Available

  • Henry Ford Hospital

    Detroit, Michigan 48202
    United States

    Site Not Available

  • Veterans Affairs Medical Center - Detroit

    Detroit, Michigan 48201-1932
    United States

    Site Not Available

  • CCOP - Grand Rapids

    Grand Rapids, Michigan 49503
    United States

    Site Not Available

  • CCOP - Beaumont

    Royal Oak, Michigan 48073-6769
    United States

    Site Not Available

  • Providence Hospital - Southfield

    Southfield, Michigan 48075-9975
    United States

    Site Not Available

  • Veterans Affairs Medical Center - Biloxi

    Biloxi, Mississippi 39531-2410
    United States

    Site Not Available

  • University of Mississippi Medical Center

    Jackson, Mississippi 39216-4505
    United States

    Site Not Available

  • Veterans Affairs Medical Center - Jackson

    Jackson, Mississippi 39216
    United States

    Site Not Available

  • Keesler Medical Center - Keesler AFB

    Keesler AFB, Mississippi 39534-2576
    United States

    Site Not Available

  • CCOP - Kansas City

    Kansas City, Missouri 64131
    United States

    Site Not Available

  • Veterans Affairs Medical Center - Kansas City

    Kansas City, Missouri 64128
    United States

    Site Not Available

  • CCOP - St. Louis-Cape Girardeau

    Saint Louis, Missouri 63141
    United States

    Site Not Available

  • St. Louis University Health Sciences Center

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • CCOP - Cancer Research for the Ozarks

    Springfield, Missouri 65807
    United States

    Site Not Available

  • CCOP - Montana Cancer Consortium

    Billings, Montana 59101
    United States

    Site Not Available

  • MBCCOP - University of New Mexico HSC

    Albuquerque, New Mexico 87131
    United States

    Site Not Available

  • Veterans Affairs Medical Center - Albuquerque

    Albuquerque, New Mexico 87108-5138
    United States

    Site Not Available

  • Veterans Affairs Medical Center - Albany

    Albany, New York 12208
    United States

    Site Not Available

  • Western New York Urology Associates

    Buffalo, New York 14220
    United States

    Site Not Available

  • Herbert Irving Comprehensive Cancer Center

    New York, New York 10032
    United States

    Site Not Available

  • James P. Wilmot Cancer Center at the University of Rochester Medical Center

    Rochester, New York 14642
    United States

    Site Not Available

  • CCOP - Southeast Cancer Control Consortium

    Winston-Salem, North Carolina 27104-4241
    United States

    Site Not Available

  • Barrett Cancer Center

    Cincinnati, Ohio 45267-0501
    United States

    Site Not Available

  • Veterans Affairs Medical Center - Cincinnati

    Cincinnati, Ohio 45220-2288
    United States

    Site Not Available

  • Cleveland Clinic Taussig Cancer Center

    Cleveland, Ohio 44195-9001
    United States

    Site Not Available

  • Arthur G. James Cancer Hospital - Ohio State University

    Columbus, Ohio 43210-1240
    United States

    Site Not Available

  • CCOP - Columbus

    Columbus, Ohio 43206
    United States

    Site Not Available

  • CCOP - Dayton

    Dayton, Ohio 45429
    United States

    Site Not Available

  • Veterans Affairs Medical Center - Dayton

    Dayton, Ohio 45428
    United States

    Site Not Available

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma 73104
    United States

    Site Not Available

  • Veterans Affairs Medical Center - Oklahoma City

    Oklahoma City, Oklahoma 73104
    United States

    Site Not Available

  • CCOP - Columbia River Program

    Portland, Oregon 97225
    United States

    Site Not Available

  • Oregon Cancer Institute

    Portland, Oregon 97201-3098
    United States

    Site Not Available

  • Veterans Affairs Medical Center - Portland

    Portland, Oregon 97207
    United States

    Site Not Available

  • Medical University of South Carolina

    Charleston, South Carolina 29425-0721
    United States

    Site Not Available

  • Veterans Affairs Medical Center - Charleston

    Charleston, South Carolina 29401-5799
    United States

    Site Not Available

  • CCOP - Greenville

    Greenville, South Carolina 29615
    United States

    Site Not Available

  • CCOP - Upstate Carolina

    Spartanburg, South Carolina 29303
    United States

    Site Not Available

  • University of Tennessee Cancer Institute

    Memphis, Tennessee 38103
    United States

    Site Not Available

  • Brooke Army Medical Center

    Fort Sam Houston, Texas 78234-6200
    United States

    Site Not Available

  • University of Texas Medical Branch

    Galveston, Texas 77555-0565
    United States

    Site Not Available

  • Baylor College of Medicine

    Houston, Texas 77030
    United States

    Site Not Available

  • University of Texas - MD Anderson Cancer Center

    Houston, Texas 77030-4095
    United States

    Site Not Available

  • Veterans Affairs Medical Center - Houston

    Houston, Texas 77030
    United States

    Site Not Available

  • Texas Tech University Health Science Center

    Lubbock, Texas 79415
    United States

    Site Not Available

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas 78229-3900
    United States

    Site Not Available

  • Veterans Affairs Medical Center - San Antonio (Murphy)

    San Antonio, Texas 78229
    United States

    Site Not Available

  • CCOP - Scott and White Hospital

    Temple, Texas 76508
    United States

    Site Not Available

  • Veterans Affairs Medical Center - Temple

    Temple, Texas 76504
    United States

    Site Not Available

  • Huntsman Cancer Institute

    Salt Lake City, Utah 84112-5550
    United States

    Site Not Available

  • Veterans Affairs Medical Center - Salt Lake City

    Salt Lake City, Utah 84148
    United States

    Site Not Available

  • Eastern Virginia Medical School

    Norfolk, Virginia 23510-1115
    United States

    Site Not Available

  • CCOP - Virginia Mason Research Center

    Seattle, Washington 98101
    United States

    Site Not Available

  • Veterans Affairs Medical Center - Seattle

    Seattle, Washington 98108
    United States

    Site Not Available

  • CCOP - Northwest

    Tacoma, Washington 98405-0986
    United States

    Site Not Available

  • Madigan Army Medical Center

    Tacoma, Washington 98431-5000
    United States

    Site Not Available

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