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Home > "C" Clinical Trials Conditions > Comparison of Cisplatin Combined With Either Paclitaxel or Gemcitabine in Treating Patients With Recurrent, Persistent, or Metastatic Cervical Cancer

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



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

For Condition: stage 4B cervical cancer,recurrent cervical cancer
Status: No longer recruiting
Sponsor(s): Southwest Oncology Group , National Cancer Institute (NCI)
Synopsis: 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.
Details: 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:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry 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
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
HarryLong,  Study Chair,  Mayo Clinic Cancer Center

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

CCOP - Dayton
Dayton,  Ohio,  45429
United States
 

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

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

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

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

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

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

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

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

CCOP - Grand Rapids
Grand Rapids,  Michigan,  49503
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
 

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

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

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

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

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

CCOP - Columbus
Columbus,  Ohio,  43206
United States
 

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

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

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

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

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

Baylor College of Medicine
Houston,  Texas,  77030
United States
 

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

CCOP - Central Illinois
Decatur,  Illinois,  62526
United States
 

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

CCOP - Greenville
Greenville,  South Carolina,  29615
United States
 

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

Henry Ford Hospital
Detroit,  Michigan,  48202
United States
 

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

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

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

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

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

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

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

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

MBCCOP - Gulf Coast
Mobile,  Alabama,  36688
United States
 

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

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

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

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

Mayo Clinic
Jacksonville,  Florida,  32224
United States
 

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

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

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

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

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

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

Boston Medical Center
Boston,  Massachusetts,  02118
United States
 

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

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

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

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

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

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

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

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

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

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

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

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

Arizona Cancer Center
Tucson,  Arizona,  85724
United States
 

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

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

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

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

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

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


Additional Information:
Study ID Numbers:
  CDR0000285630;  SWOG-S0227
Study Start Date: 
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00057928

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