S9810: Gemcitabine Plus Cisplatin in Treating Patients With Malignant Mesothelioma of the Pleura That Cannot Be Removed by Surgery
- Registration Number
- NCT00003723
- Lead Sponsor
- SWOG Cancer Research Network
- 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.
PURPOSE: Phase II trial to study the effectiveness of gemcitabine plus cisplatin in treating patients with malignant mesothelioma of the pleura that cannot be removed by surgery.
- Detailed Description
OBJECTIVES: I. Estimate overall survival and confirmed and unconfirmed complete and partial response in patients with unresectable malignant mesothelioma of the pleura treated with gemcitabine plus cisplatin. II. Evaluate the qualitative and quantitative toxicities of this regimen in this patient population.
OUTLINE: Patients receive gemcitabine IV over 30 minutes, immediately followed by cisplatin IV over 30 minutes on days 1, 8, and 15. Courses are repeated every 28 days. Treatment continues in the absence of unacceptable toxicity or disease progression. Patients with a complete response receive 2 additional courses of therapy. Patients are followed every 6 months until death.
PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study within 25 months.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 57
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Gemcitabine/Cisplatin gemcitabine hydrochloride Gemcitabine 1000 mg/m\^2 days 1, 8 15 (q 28 days) cisplatin 30 mg/m\^2 days 1, 8, 15 (q 28 days)
- Primary Outcome Measures
Name Time Method Estimate overall survival monthly while patient on treatment. Once off treatment every 6 months
- Secondary Outcome Measures
Name Time Method qualitative and quantitative toxicities week 1, 2, 3 (q 28 days) confirmed and unconfirmed complete and partial response every 8 weeks until progression
Related Research Topics
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Trial Locations
- Locations (84)
Beckman Research Institute, City of Hope
🇺🇸Los Angeles, California, United States
Veterans Affairs Outpatient Clinic - Martinez
🇺🇸Martinez, California, United States
Providence Hospital - Southfield
🇺🇸Southfield, Michigan, United States
CCOP - Columbus
🇺🇸Columbus, Ohio, United States
Cleveland Clinic Cancer Center
🇺🇸Cleveland, Ohio, United States
Boston Medical Center
🇺🇸Boston, Massachusetts, United States
Arizona Cancer Center
🇺🇸Tucson, Arizona, United States
Veterans Affairs Medical Center - Little Rock (McClellan)
🇺🇸Little Rock, Arkansas, United States
CCOP - Virginia Mason Research Center
🇺🇸Seattle, Washington, United States
Swedish Cancer Institute
🇺🇸Seattle, Washington, United States
UCSF Cancer Center and Cancer Research Institute
🇺🇸San Francisco, California, United States
Barrett Cancer Center, The University Hospital
🇺🇸Cincinnati, Ohio, United States
Veterans Affairs Medical Center - Cincinnati
🇺🇸Cincinnati, Ohio, United States
Veterans Affairs Medical Center - San Antonio (Murphy)
🇺🇸San Antonio, 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
CCOP - Wichita
🇺🇸Wichita, Kansas, United States
Veterans Affairs Medical Center - Wichita
🇺🇸Wichita, Kansas, United States
Keesler Medical Center - Keesler AFB
🇺🇸Keesler AFB, Mississippi, United States
Louisiana State University Health Sciences Center - Shreveport
🇺🇸Shreveport, Louisiana, United States
Veterans Affairs Medical Center - Jackson
🇺🇸Jackson, Mississippi, United States
Veterans Affairs Medical Center - Tucson
🇺🇸Tucson, Arizona, United States
University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
Tulane University School of Medicine
🇺🇸New Orleans, Louisiana, United States
CCOP - Montana Cancer Consortium
🇺🇸Billings, Montana, United States
University of Mississippi Medical Center
🇺🇸Jackson, Mississippi, United States
MBCCOP - LSU Medical Center
🇺🇸New Orleans, Louisiana, United States
Veterans Affairs Medical Center - New Orleans
🇺🇸New Orleans, Louisiana, United States
Veterans Affairs Medical Center - Shreveport
🇺🇸Shreveport, Louisiana, United States
CCOP - Greater Phoenix
🇺🇸Phoenix, Arizona, United States
University of Colorado Cancer Center
🇺🇸Denver, Colorado, United States
Veterans Affairs Medical Center - Phoenix (Hayden)
🇺🇸Phoenix, Arizona, United States
University of California Davis Medical Center
🇺🇸Sacramento, California, United States
Veterans Affairs Medical Center - Detroit
🇺🇸Detroit, Michigan, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Veterans Affairs Medical Center - Denver
🇺🇸Denver, Colorado, United States
Barbara Ann Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States
Veterans Affairs Medical Center - Ann Arbor
🇺🇸Ann Arbor, Michigan, United States
Oklahoma Medical Research Foundation
🇺🇸Oklahoma City, Oklahoma, United States
Veterans Affairs Medical Center - Oklahoma City
🇺🇸Oklahoma City, Oklahoma, United States
Oregon Cancer Center at Oregon Health Sciences University
🇺🇸Portland, Oregon, United States
Veterans Affairs Medical Center - Portland
🇺🇸Portland, Oregon, United States
CCOP - Columbia River Program
🇺🇸Portland, Oregon, United States
MBCCOP - University of South Alabama
🇺🇸Mobile, Alabama, United States
Jonsson Comprehensive Cancer Center, UCLA
🇺🇸Los Angeles, California, United States
Veterans Affairs Medical Center - Long Beach
🇺🇸Long Beach, California, United States
USC/Norris Comprehensive Cancer Center
🇺🇸Los Angeles, California, United States
CCOP - Bay Area Tumor Institute
🇺🇸Oakland, California, United States
David Grant Medical Center
🇺🇸Travis Air Force Base, California, United States
CCOP - Santa Rosa Memorial Hospital
🇺🇸Santa Rosa, California, United States
CCOP - Atlanta Regional
🇺🇸Atlanta, Georgia, United States
Dwight David Eisenhower Army Medical Center
🇺🇸Fort Gordon, Georgia, United States
Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
🇺🇸Hines, Illinois, United States
Cancer Research Center of Hawaii
🇺🇸Honolulu, Hawaii, United States
Loyola University Medical Center
🇺🇸Maywood, Illinois, United States
Veterans Affairs Medical Center - Lexington
🇺🇸Lexington, Kentucky, United States
Albert B. Chandler Medical Center, University of Kentucky
🇺🇸Lexington, Kentucky, United States
University of Michigan Comprehensive Cancer Center
🇺🇸Ann Arbor, Michigan, United States
Veterans Affairs Medical Center - Boston (Jamaica Plain)
🇺🇸Jamaica Plain, Massachusetts, United States
CCOP - Grand Rapids Clinical Oncology Program
🇺🇸Grand Rapids, Michigan, United States
Veterans Affairs Medical Center - Biloxi
🇺🇸Biloxi, 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
MBCCOP - University of New Mexico HSC
🇺🇸Albuquerque, New Mexico, United States
Veterans Affairs Medical Center - Albuquerque
🇺🇸Albuquerque, New Mexico, United States
Herbert Irving Comprehensive Cancer Center
🇺🇸New York, New York, United States
CCOP - Dayton
🇺🇸Kettering, Ohio, United States
Veterans Affairs Medical Center - Dayton
🇺🇸Dayton, Ohio, United States
CCOP - Greenville
🇺🇸Greenville, South Carolina, United States
CCOP - Upstate Carolina
🇺🇸Spartanburg, South Carolina, United States
University of Texas Medical Branch
🇺🇸Galveston, Texas, United States
Brooke Army Medical Center
🇺🇸Fort Sam 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
CCOP - Scott and White Hospital
🇺🇸Temple, Texas, United States
Veterans Affairs Medical Center - Temple
🇺🇸Temple, Texas, United States
Veterans Affairs Medical Center - Seattle
🇺🇸Seattle, Washington, United States
CCOP - Northwest
🇺🇸Tacoma, Washington, United States
CCOP - Cancer Research for the Ozarks
🇺🇸Springfield, Missouri, United States
CCOP - Central Illinois
🇺🇸Decatur, Illinois, United States
Veterans Affairs Medical Center - Brooklyn
🇺🇸Brooklyn, New York, United States
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States