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Phase II Study of Gemcitabine and Cisplatin in Unresectable Malignant Mesothelioma (NCT00003723)

National Cancer Institute (NCI)
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.
  • Drug: gemcitabine hydrochloride
    Gemcitabine 1000 mg/m^2 days 1, 8 15 (q 28 days)
    Ages eligible for Study
    18 Years and older
    Genders eligible for Study
    All
    Accepts Healthy Volunteers
    No
    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.

    84 locations

    United States (84)
    • MBCCOP - University of South Alabama
      Not specified
      Mobile, Alabama, United States, 36688
    • CCOP - Greater Phoenix
      Not specified
      Phoenix, Arizona, United States, 85006-2726
    • Veterans Affairs Medical Center - Phoenix (Hayden)
      Not specified
      Phoenix, Arizona, United States, 85012
    • Veterans Affairs Medical Center - Tucson
      Not specified
      Tucson, Arizona, United States, 85723
    • Arizona Cancer Center
      Not specified
      Tucson, Arizona, United States, 85724
    • University of Arkansas for Medical Sciences
      Not specified
      Little Rock, Arkansas, United States, 72205
    • Veterans Affairs Medical Center - Little Rock (McClellan)
      Not specified
      Little Rock, Arkansas, United States, 72205
    • Veterans Affairs Medical Center - Long Beach
      Not specified
      Long Beach, California, United States, 90822
    • USC/Norris Comprehensive Cancer Center
      Not specified
      Los Angeles, California, United States, 90033-0800
    • Jonsson Comprehensive Cancer Center, UCLA
      Not specified
      Los Angeles, California, United States, 90095-1781
    • Beckman Research Institute, City of Hope
      Not specified
      Los Angeles, California, United States, 91010
    • Veterans Affairs Outpatient Clinic - Martinez
      Not specified
      Martinez, California, United States, 94553
    • CCOP - Bay Area Tumor Institute
      Not specified
      Oakland, California, United States, 94609-3305
    • University of California Davis Medical Center
      Not specified
      Sacramento, California, United States, 95817
    • UCSF Cancer Center and Cancer Research Institute
      Not specified
      San Francisco, California, United States, 94115-0128
    • CCOP - Santa Rosa Memorial Hospital
      Not specified
      Santa Rosa, California, United States, 95403
    • David Grant Medical Center
      Not specified
      Travis Air Force Base, California, United States, 94535
    • Veterans Affairs Medical Center - Denver
      Not specified
      Denver, Colorado, United States, 80220
    • University of Colorado Cancer Center
      Not specified
      Denver, Colorado, United States, 80262
    • CCOP - Atlanta Regional
      Not specified
      Atlanta, Georgia, United States, 30342-1701
    • Dwight David Eisenhower Army Medical Center
      Not specified
      Fort Gordon, Georgia, United States, 30905-5650
    • Cancer Research Center of Hawaii
      Not specified
      Honolulu, Hawaii, United States, 96813
    • CCOP - Central Illinois
      Not specified
      Decatur, Illinois, United States, 62526
    • Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
      Not specified
      Hines, Illinois, United States, 60141
    • Loyola University Medical Center
      Not specified
      Maywood, Illinois, United States, 60153
    • University of Kansas Medical Center
      Not specified
      Kansas City, Kansas, United States, 66160-7357
    • CCOP - Wichita
      Not specified
      Wichita, Kansas, United States, 67214-3882
    • Veterans Affairs Medical Center - Wichita
      Not specified
      Wichita, Kansas, United States, 67218
    • Veterans Affairs Medical Center - Lexington
      Not specified
      Lexington, Kentucky, United States, 40511-1093
    • Albert B. Chandler Medical Center, University of Kentucky
      Not specified
      Lexington, Kentucky, United States, 40536-0084
    • MBCCOP - LSU Medical Center
      Not specified
      New Orleans, Louisiana, United States, 70112
    • Tulane University School of Medicine
      Not specified
      New Orleans, Louisiana, United States, 70112
    • Veterans Affairs Medical Center - New Orleans
      Not specified
      New Orleans, Louisiana, United States, 70112
    • Louisiana State University Health Sciences Center - Shreveport
      Not specified
      Shreveport, Louisiana, United States, 71130-3932
    • Veterans Affairs Medical Center - Shreveport
      Not specified
      Shreveport, Louisiana, United States, 71130
    • Boston Medical Center
      Not specified
      Boston, Massachusetts, United States, 02118
    • Veterans Affairs Medical Center - Boston (Jamaica Plain)
      Not specified
      Jamaica Plain, Massachusetts, United States, 02130
    • Veterans Affairs Medical Center - Ann Arbor
      Not specified
      Ann Arbor, Michigan, United States, 48105
    • University of Michigan Comprehensive Cancer Center
      Not specified
      Ann Arbor, Michigan, United States, 48109-0752
    • Veterans Affairs Medical Center - Detroit
      Not specified
      Detroit, Michigan, United States, 48201-1932
    • Barbara Ann Karmanos Cancer Institute
      Not specified
      Detroit, Michigan, United States, 48201
    • Henry Ford Hospital
      Not specified
      Detroit, Michigan, United States, 48202
    • CCOP - Grand Rapids Clinical Oncology Program
      Not specified
      Grand Rapids, Michigan, United States, 49503
    • Providence Hospital - Southfield
      Not specified
      Southfield, Michigan, United States, 48075-9975
    • Veterans Affairs Medical Center - Biloxi
      Not specified
      Biloxi, Mississippi, United States, 39531-2410
    • University of Mississippi Medical Center
      Not specified
      Jackson, Mississippi, United States, 39216-4505
    • Veterans Affairs Medical Center - Jackson
      Not specified
      Jackson, Mississippi, United States, 39216
    • Keesler Medical Center - Keesler AFB
      Not specified
      Keesler AFB, Mississippi, United States, 39534-2576
    • Veterans Affairs Medical Center - Kansas City
      Not specified
      Kansas City, Missouri, United States, 64128
    • CCOP - Kansas City
      Not specified
      Kansas City, Missouri, United States, 64131
    • St. Louis University Health Sciences Center
      Not specified
      Saint Louis, Missouri, United States, 63110-0250
    • CCOP - St. Louis-Cape Girardeau
      Not specified
      Saint Louis, Missouri, United States, 63141
    • CCOP - Cancer Research for the Ozarks
      Not specified
      Springfield, Missouri, United States, 65807
    • CCOP - Montana Cancer Consortium
      Not specified
      Billings, Montana, United States, 59101
    • Veterans Affairs Medical Center - Albuquerque
      Not specified
      Albuquerque, New Mexico, United States, 87108-5138
    • MBCCOP - University of New Mexico HSC
      Not specified
      Albuquerque, New Mexico, United States, 87131
    • Veterans Affairs Medical Center - Brooklyn
      Not specified
      Brooklyn, New York, United States, 11209
    • Herbert Irving Comprehensive Cancer Center
      Not specified
      New York, New York, United States, 10032
    • Barrett Cancer Center, The University Hospital
      Not specified
      Cincinnati, Ohio, United States, 45219
    • Veterans Affairs Medical Center - Cincinnati
      Not specified
      Cincinnati, Ohio, United States, 45220-2288
    • Cleveland Clinic Cancer Center
      Not specified
      Cleveland, Ohio, United States, 44195
    • CCOP - Columbus
      Not specified
      Columbus, Ohio, United States, 43206
    • Veterans Affairs Medical Center - Dayton
      Not specified
      Dayton, Ohio, United States, 45428
    • CCOP - Dayton
      Not specified
      Kettering, Ohio, United States, 45429
    • Oklahoma Medical Research Foundation
      Not specified
      Oklahoma City, Oklahoma, United States, 73104
    • Veterans Affairs Medical Center - Oklahoma City
      Not specified
      Oklahoma City, Oklahoma, United States, 73104
    • Oregon Cancer Center at Oregon Health Sciences University
      Not specified
      Portland, Oregon, United States, 97201-3098
    • Veterans Affairs Medical Center - Portland
      Not specified
      Portland, Oregon, United States, 97207
    • CCOP - Columbia River Program
      Not specified
      Portland, Oregon, United States, 97213
    • CCOP - Greenville
      Not specified
      Greenville, South Carolina, United States, 29615
    • CCOP - Upstate Carolina
      Not specified
      Spartanburg, South Carolina, United States, 29303
    • Brooke Army Medical Center
      Not specified
      Fort Sam Houston, Texas, United States, 78234
    • University of Texas Medical Branch
      Not specified
      Galveston, Texas, United States, 77555-1329
    • Texas Tech University Health Science Center
      Not specified
      Lubbock, Texas, United States, 79423
    • University of Texas Health Science Center at San Antonio
      Not specified
      San Antonio, Texas, United States, 78284-7811
    • Veterans Affairs Medical Center - San Antonio (Murphy)
      Not specified
      San Antonio, Texas, United States, 78284
    • Veterans Affairs Medical Center - Temple
      Not specified
      Temple, Texas, United States, 76504
    • CCOP - Scott and White Hospital
      Not specified
      Temple, Texas, United States, 76508
    • Huntsman Cancer Institute
      Not specified
      Salt Lake City, Utah, United States, 84132
    • Veterans Affairs Medical Center - Salt Lake City
      Not specified
      Salt Lake City, Utah, United States, 84148
    • CCOP - Virginia Mason Research Center
      Not specified
      Seattle, Washington, United States, 98101
    • Swedish Cancer Institute
      Not specified
      Seattle, Washington, United States, 98104
    • Veterans Affairs Medical Center - Seattle
      Not specified
      Seattle, Washington, United States, 98108
    • CCOP - Northwest
      Not specified
      Tacoma, Washington, United States, 98405-0986
    Status:
    completed
    Type:
    Interventional
    Phase:
    Start:
    31 January, 1999
    Updated:
    04 October, 2012
    Participants:
    57
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