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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00057928
Recruitment Status : Withdrawn (lack of accrual)
First Posted : April 9, 2003
Last Update Posted : June 13, 2012
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Southwest Oncology Group

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.


Condition or disease Intervention/treatment Phase
Cervical Cancer Drug: cisplatin Drug: gemcitabine hydrochloride Drug: paclitaxel Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Primary Purpose: Treatment
Official Title: Phase III Randomized Trial of Cisplatin/Paclitaxel Versus Cisplatin/Gemcitabine in Recurrent, Persistent or Metastatic Carcinoma of the Cervix
Study Start Date : April 2003
Actual Primary Completion Date : July 2003
Actual Study Completion Date : July 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer





Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00057928


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Locations
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United States, Alabama
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, United States, 35294-3300
MBCCOP - Gulf Coast
Mobile, Alabama, United States, 36688
United States, Arizona
CCOP - Greater Phoenix
Phoenix, Arizona, United States, 85006-2726
Veterans Affairs Medical Center - Phoenix (Carl T. Hayden)
Phoenix, Arizona, United States, 85012
Veterans Affairs Medical Center - Tucson
Tucson, Arizona, United States, 85723
Arizona Cancer Center
Tucson, Arizona, United States, 85724
United States, Arkansas
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
Veterans Affairs Medical Center - Little Rock (McClellan)
Little Rock, Arkansas, United States, 72205
United States, California
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States, 90033-0804
Veterans Affairs Medical Center - West Los Angeles
Los Angeles, California, United States, 90073
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States, 90095-1781
Veterans Affairs Outpatient Clinic - Martinez
Martinez, California, United States, 94553
CCOP - Bay Area Tumor Institute
Oakland, California, United States, 94609-3305
Chao Family Comprehensive Cancer Center
Orange, California, United States, 92868
University of California Davis Cancer Center
Sacramento, California, United States, 95817
Veterans Affairs Medical Center - San Francisco
San Francisco, California, United States, 94121
CCOP - Santa Rosa Memorial Hospital
Santa Rosa, California, United States, 95403
David Grant Medical Center
Travis Air Force Base, California, United States, 94535
United States, Colorado
University of Colorado Cancer Center
Denver, Colorado, United States, 80010
Veterans Affairs Medical Center - Denver
Denver, Colorado, United States, 80220
United States, District of Columbia
MBCCOP - Howard University Cancer Center
Washington, District of Columbia, United States, 20060
United States, Florida
Mayo Clinic
Jacksonville, Florida, United States, 32224
United States, Georgia
CCOP - Atlanta Regional
Atlanta, Georgia, United States, 30342-1701
Dwight David Eisenhower Army Medical Center
Fort Gordon, Georgia, United States, 30905-5650
United States, Hawaii
Cancer Research Center of Hawaii
Honolulu, Hawaii, United States, 96813-2424
Tripler Army Medical Center
Honolulu, Hawaii, United States, 96859-5000
United States, Illinois
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, United States, 60611-W227
MBCCOP - University of Illinois at Chicago
Chicago, Illinois, United States, 60612-7323
Veterans Affairs Medical Center - Chicago (Westside Hospital)
Chicago, Illinois, United States, 60612
CCOP - Central Illinois
Decatur, Illinois, United States, 62526
Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
Hines, Illinois, United States, 60141
Loyola University Medical Center
Maywood, Illinois, United States, 60153-5500
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160-7353
CCOP - Wichita
Wichita, Kansas, United States, 67214-3882
Veterans Affairs Medical Center - Wichita
Wichita, Kansas, United States, 67218
United States, Kentucky
Veterans Affairs Medical Center - Lexington
Lexington, Kentucky, United States, 40502-2236
Albert B. Chandler Medical Center, University of Kentucky
Lexington, Kentucky, United States, 40536-0084
United States, Louisiana
MBCCOP - LSU Health Sciences Center
New Orleans, Louisiana, United States, 70112
Tulane University School of Medicine
New Orleans, Louisiana, United States, 70112
Veterans Affairs Medical Center - New Orleans
New Orleans, Louisiana, United States, 70112
Louisiana State University Health Sciences Center - Shreveport
Shreveport, Louisiana, United States, 71130-3932
Veterans Affairs Medical Center - Shreveport
Shreveport, Louisiana, United States, 71130
United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
Veterans Affairs Medical Center - Boston (Jamaica Plain)
Jamaica Plain, Massachusetts, United States, 02130
United States, Michigan
Veterans Affairs Medical Center - Ann Arbor
Ann Arbor, Michigan, United States, 48105
CCOP - Michigan Cancer Research Consortium
Ann Arbor, Michigan, United States, 48106
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109-0912
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-1379
Veterans Affairs Medical Center - Detroit
Detroit, Michigan, United States, 48201-1932
Henry Ford Hospital
Detroit, Michigan, United States, 48202
CCOP - Grand Rapids
Grand Rapids, Michigan, United States, 49503
CCOP - Beaumont
Royal Oak, Michigan, United States, 48073-6769
Providence Hospital - Southfield
Southfield, Michigan, United States, 48075-9975
United States, Mississippi
Veterans Affairs Medical Center - Biloxi
Biloxi, Mississippi, United States, 39531-2410
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216-4505
Veterans Affairs Medical Center - Jackson
Jackson, Mississippi, United States, 39216
Keesler Medical Center - Keesler AFB
Keesler AFB, Mississippi, United States, 39534-2576
United States, Missouri
Veterans Affairs Medical Center - Kansas City
Kansas City, Missouri, United States, 64128
CCOP - Kansas City
Kansas City, Missouri, United States, 64131
St. Louis University Health Sciences Center
Saint Louis, Missouri, United States, 63110
CCOP - St. Louis-Cape Girardeau
Saint Louis, Missouri, United States, 63141
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, United States, 65807
United States, Montana
CCOP - Montana Cancer Consortium
Billings, Montana, United States, 59101
United States, New Mexico
Veterans Affairs Medical Center - Albuquerque
Albuquerque, New Mexico, United States, 87108-5138
MBCCOP - University of New Mexico HSC
Albuquerque, New Mexico, United States, 87131
United States, New York
Veterans Affairs Medical Center - Albany
Albany, New York, United States, 12208
Western New York Urology Associates
Buffalo, New York, United States, 14220
Herbert Irving Comprehensive Cancer Center
New York, New York, United States, 10032
James P. Wilmot Cancer Center at the University of Rochester Medical Center
Rochester, New York, United States, 14642
United States, North Carolina
CCOP - Southeast Cancer Control Consortium
Winston-Salem, North Carolina, United States, 27104-4241
United States, Ohio
Veterans Affairs Medical Center - Cincinnati
Cincinnati, Ohio, United States, 45220-2288
Barrett Cancer Center
Cincinnati, Ohio, United States, 45267-0501
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195-9001
CCOP - Columbus
Columbus, Ohio, United States, 43206
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, United States, 43210-1240
Veterans Affairs Medical Center - Dayton
Dayton, Ohio, United States, 45428
CCOP - Dayton
Dayton, Ohio, United States, 45429
United States, Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Veterans Affairs Medical Center - Oklahoma City
Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
Oregon Cancer Institute
Portland, Oregon, United States, 97201-3098
Veterans Affairs Medical Center - Portland
Portland, Oregon, United States, 97207
CCOP - Columbia River Program
Portland, Oregon, United States, 97225
United States, South Carolina
Veterans Affairs Medical Center - Charleston
Charleston, South Carolina, United States, 29401-5799
Medical University of South Carolina
Charleston, South Carolina, United States, 29425-0721
CCOP - Greenville
Greenville, South Carolina, United States, 29615
CCOP - Upstate Carolina
Spartanburg, South Carolina, United States, 29303
United States, Tennessee
University of Tennessee Cancer Institute
Memphis, Tennessee, United States, 38103
United States, Texas
Brooke Army Medical Center
Fort Sam Houston, Texas, United States, 78234-6200
University of Texas Medical Branch
Galveston, Texas, United States, 77555-0565
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States, 77030-4095
Baylor College of Medicine
Houston, Texas, United States, 77030
Veterans Affairs Medical Center - Houston
Houston, Texas, United States, 77030
Texas Tech University Health Science Center
Lubbock, Texas, United States, 79415
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229-3900
Veterans Affairs Medical Center - San Antonio (Murphy)
San Antonio, Texas, United States, 78229
Veterans Affairs Medical Center - Temple
Temple, Texas, United States, 76504
CCOP - Scott and White Hospital
Temple, Texas, United States, 76508
United States, Utah
Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112-5550
Veterans Affairs Medical Center - Salt Lake City
Salt Lake City, Utah, United States, 84148
United States, Virginia
Eastern Virginia Medical School
Norfolk, Virginia, United States, 23510-1115
United States, Washington
CCOP - Virginia Mason Research Center
Seattle, Washington, United States, 98101
Veterans Affairs Medical Center - Seattle
Seattle, Washington, United States, 98108
CCOP - Northwest
Tacoma, Washington, United States, 98405-0986
Madigan Army Medical Center
Tacoma, Washington, United States, 98431-5000
Canada, British Columbia
British Columbia Cancer Agency
Vancouver, British Columbia, Canada, V5Z 4E6
Sponsors and Collaborators
Southwest Oncology Group
National Cancer Institute (NCI)
Investigators
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Study Chair: Harry J. Long, MD Mayo Clinic

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Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00057928     History of Changes
Other Study ID Numbers: CDR0000285630
S0227 ( Other Identifier: SWOG )
U10CA032102 ( U.S. NIH Grant/Contract )
First Posted: April 9, 2003    Key Record Dates
Last Update Posted: June 13, 2012
Last Verified: June 2012

Keywords provided by Southwest Oncology Group:
recurrent cervical cancer
stage IVB cervical cancer

Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Paclitaxel
Albumin-Bound Paclitaxel
Cisplatin
Gemcitabine
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs