Mesothelioma Related Clinical Trials:
Phase II Study of Gemcitabine and Cisplatin in Unresectable Malignant Mesothelioma

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Status: Active
Sponsors and Collaborators: Southwest Oncology Group, National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
Government Identifier: NCT00003723

Condition: Malignant Mesothelioma
Intervention: Drug: cisplatin; Drug: gemcitabine hydrochloride, Procedure: chemotherapy

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Purpose:


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.

Study Type:   Interventional
Study Design:   Treatment
Official Title:   Phase II Study of Gemcitabine and Cisplatin in Unresectable Malignant Mesothelioma

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment:   50
Study Start Date:   February 1999

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.

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Eligibility:

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

DISEASE CHARACTERISTICS: Histologically confirmed diagnosis of unresectable malignant mesothelioma of the pleura Epithelial, fibrosarcomatous, or mixed type Bidimensionally measurable disease No CNS metastases

PATIENT CHARACTERISTICS: Age: Over 18 Performance status: SWOG 0-2 Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Platelet count at least lower limit of normal Hepatic: Bilirubin no greater than 2.0 mg/dL SGOT or SGPT no greater than 2.5 times upper limit of normal (ULN) Renal: Creatinine no greater than 2 times ULN AND Creatinine clearance at least 60 mL/min Other: Not pregnant or nursing Fertile patients must use effective contraception No other prior malignancy within the past 5 years except adequately treated basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, or adequately treated stage I or II cancer currently in complete remission Must have chest x-ray within the past 28 days

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy No other concurrent chemotherapy Endocrine therapy: Concurrent hormones for non-disease-related conditions allowed Concurrent steroids for antiemesis, adrenal failure, or septic shock allowed Radiotherapy: No prior radiotherapy No concurrent radiotherapy Surgery: At least 4 weeks since prior major surgery and recovered

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Contacts and Locations:

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003723

Locations
United States, Alabama
MBCCOP - University of South Alabama    
      Mobile, Alabama, United States, 36688
United States, Arizona
Arizona Cancer Center    
      Tucson, Arizona, United States, 85724
CCOP - Greater Phoenix    
      Phoenix, Arizona, United States, 85006-2726
Veterans Affairs Medical Center - Phoenix (Hayden)    
      Phoenix, Arizona, United States, 85012
Veterans Affairs Medical Center - Tucson    
      Tucson, Arizona, United States, 85723
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
Beckman Research Institute, City of Hope    
      Los Angeles, California, United States, 91010
CCOP - Bay Area Tumor Institute    
      Oakland, California, United States, 94609-3305
CCOP - Santa Rosa Memorial Hospital    
      Santa Rosa, California, United States, 95403
David Grant Medical Center    
      Travis Air Force Base, California, United States, 94535
Jonsson Comprehensive Cancer Center, UCLA    
      Los Angeles, California, United States, 90095-1781
UCSF Cancer Center and Cancer Research Institute    
      San Francisco, California, United States, 94115-0128
University of California Davis Medical Center    
      Sacramento, California, United States, 95817
USC/Norris Comprehensive Cancer Center    
      Los Angeles, California, United States, 90033-0800
Veterans Affairs Medical Center - Long Beach    
      Long Beach, California, United States, 90822
Veterans Affairs Outpatient Clinic - Martinez    
      Martinez, California, United States, 94553
United States, Colorado
University of Colorado Cancer Center    
      Denver, Colorado, United States, 80262
Veterans Affairs Medical Center - Denver    
      Denver, Colorado, United States, 80220
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
United States, Illinois
CCOP - Central Illinois    
      Decatur, Illinois, United States, 62526
Loyola University Medical Center    
      Maywood, Illinois, United States, 60153
Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)    
      Hines, Illinois, United States, 60141
United States, Kansas
CCOP - Wichita    
      Wichita, Kansas, United States, 67214-3882
University of Kansas Medical Center    
      Kansas City, Kansas, United States, 66160-7357
Veterans Affairs Medical Center - Wichita    
      Wichita, Kansas, United States, 67218
United States, Kentucky
Albert B. Chandler Medical Center, University of Kentucky    
      Lexington, Kentucky, United States, 40536-0084
Veterans Affairs Medical Center - Lexington    
      Lexington, Kentucky, United States, 40511-1093
United States, Louisiana
Louisiana State University Health Sciences Center - Shreveport    
      Shreveport, Louisiana, United States, 71130-3932
MBCCOP - LSU Medical 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
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
University of Michigan Comprehensive Cancer Center    
      Ann Arbor, Michigan, United States, 48109-0752
CCOP - Grand Rapids Clinical Oncology Program    
      Grand Rapids, Michigan, United States, 49503
Henry Ford Hospital    
      Detroit, Michigan, United States, 48202
Providence Hospital - Southfield    
      Southfield, Michigan, United States, 48075-9975
Barbara Ann Karmanos Cancer Institute    
      Detroit, Michigan, United States, 48201
Veterans Affairs Medical Center - Ann Arbor    
      Ann Arbor, Michigan, United States, 48105
Veterans Affairs Medical Center - Detroit    
      Detroit, Michigan, United States, 48201-1932
United States, Mississippi
Keesler Medical Center - Keesler AFB    
      Keesler AFB, Mississippi, United States, 39534-2576
University of Mississippi Medical Center    
      Jackson, Mississippi, United States, 39216-4505
Veterans Affairs Medical Center - Biloxi    
      Biloxi, Mississippi, United States, 39531-2410
Veterans Affairs Medical Center - Jackson    
      Jackson, Mississippi, United States, 39216
United States, Missouri
Veterans Affairs Medical Center - Kansas City    
      Kansas City, Missouri, United States, 64128
CCOP - Kansas City    
      Kansas City, Missouri, United States, 64131
CCOP - St. Louis-Cape Girardeau    
      Saint Louis, Missouri, United States, 63141
St. Louis University Health Sciences Center    
      Saint Louis, Missouri, United States, 63110-0250
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
MBCCOP - University of New Mexico HSC    
      Albuquerque, New Mexico, United States, 87131
Veterans Affairs Medical Center - Albuquerque    
      Albuquerque, New Mexico, United States, 87108-5138
United States, New York
Herbert Irving Comprehensive Cancer Center    
      New York, New York, United States, 10032
Veterans Affairs Medical Center - Brooklyn    
      Brooklyn, New York, United States, 11209
United States, Ohio
Veterans Affairs Medical Center - Cincinnati    
      Cincinnati, Ohio, United States, 45220-2288
CCOP - Columbus    
      Columbus, Ohio, United States, 43206
CCOP - Dayton    
      Kettering, Ohio, United States, 45429
Cleveland Clinic Cancer Center    
      Cleveland, Ohio, United States, 44195
Barrett Cancer Center, The University Hospital    
      Cincinnati, Ohio, United States, 45219
Veterans Affairs Medical Center - Dayton    
      Dayton, Ohio, United States, 45428
United States, Oklahoma
Oklahoma Medical Research Foundation    
      Oklahoma City, Oklahoma, United States, 73104
Veterans Affairs Medical Center - Oklahoma City    
      Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
CCOP - Columbia River Program    
      Portland, Oregon, United States, 97213
Oregon Cancer Center at Oregon Health Sciences University    
      Portland, Oregon, United States, 97201-3098
Veterans Affairs Medical Center - Portland    
      Portland, Oregon, United States, 97207
United States, South Carolina
CCOP - Greenville    
      Greenville, South Carolina, United States, 29615
CCOP - Upstate Carolina    
      Spartanburg, South Carolina, United States, 29303
United States, Texas
Brooke Army Medical Center    
      Fort Sam Houston, Texas, United States, 78234
CCOP - Scott and White Hospital    
      Temple, Texas, United States, 76508
Texas Tech University Health Science Center    
      Lubbock, Texas, United States, 79423
University of Texas Health Science Center at San Antonio    
      San Antonio, Texas, United States, 78284-7811
University of Texas Medical Branch    
      Galveston, Texas, United States, 77555-1329
Veterans Affairs Medical Center - San Antonio (Murphy)    
      San Antonio, Texas, United States, 78284
Veterans Affairs Medical Center - Temple    
      Temple, Texas, United States, 76504
United States, Utah
Huntsman Cancer Institute    
      Salt Lake City, Utah, United States, 84132
Veterans Affairs Medical Center - Salt Lake City    
      Salt Lake City, Utah, United States, 84148
United States, Washington
CCOP - Northwest    
      Tacoma, Washington, United States, 98405-0986
CCOP - Virginia Mason Research Center    
      Seattle, Washington, United States, 98101
Swedish Cancer Institute    
      Seattle, Washington, United States, 98104
Veterans Affairs Medical Center - Seattle    
      Seattle, Washington, United States, 98108

Sponsors and Collaborators
Southwest Oncology Group
National Cancer Institute (NCI)

Investigators
Study Chair:     Robert N. Taub, MD, PhD     Herbert Irving Comprehensive Cancer Center    

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Additional Information:

Publications of Results:
Kalmadi SR, Rankin C, Kraut MJ, Jacobs AD, Petrylak DP, Adelstein DJ, Keohan ML, Taub RN, Borden EC. Gemcitabine and cisplatin in unresectable malignant mesothelioma of the pleura: A phase II study of the Southwest Oncology Group (SWOG 9810). Lung Cancer. 2007 Nov 13; [Epub ahead of print]
 

Study ID Numbers:   CDR0000066832, SWOG-S9810
First Received:   November 1, 1999
Last Updated:   December 15, 2007
ClinicalTrials.gov Identifier:   NCT00003723
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
advanced malignant mesothelioma  
epithelial mesothelioma  
sarcomatous mesothelioma  

Study placed in the following topic categories:
Cisplatin
Mesothelioma
Gemcitabine
Adenoma
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Mesothelioma
Antimetabolites
Anti-Infective Agents
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Neoplasms, Mesothelial
Antineoplastic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Immunosuppressive Agents
Antiviral Agents
Pharmacologic Actions
Neoplasms
Radiation-Sensitizing Agents
Therapeutic Uses

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