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Erlotinib in Treating Patients With Malignant Mesothelioma of the Lung Clinical Trials Data presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, calls or treatment using a genuine doctor. We are not docs. Always consult your dr. on Erlotinib in Treating Patients With Malignant Mesothelioma of the Lung conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Erlotinib in Treating Patients With Malignant Mesothelioma of the Lung Clinical research trials and Erlotinib in Treating Patients With Malignant Mesothelioma of the Lung healthcare trials occur in a lot of of places throughout the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the potency of new drugs. The intent of the studies / undertakings is to figure out certain human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector corporations to locate remedies for all kinds of circumstances, including Erlotinib in Treating Patients With Malignant Mesothelioma of the Lung. Erlotinib in Treating Patients With Malignant Mesothelioma of the Lung Clinical Trials and other clinical trials allow volunteers to obtain health treatment alternatives before they are available to the masses. Many times the participants undergo treatment for free, and sometimes they are paid for their time. Occasionally there is a cost for a Erlotinib in Treating Patients With Malignant Mesothelioma of the Lung clinical trial. Participants typically obtain the most effective healthcare available for their Erlotinib in Treating Patients With Malignant Mesothelioma of the Lung condition. Dangers are a reality, nonetheless, and can include extra or frequent mD trips, medical hazards (potentially life-endangering), and/or the treatment being uneffective. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "E" Clinical Trials Conditions > Erlotinib in Treating Patients With Malignant Mesothelioma of the Lung  Erlotinib in Treating Patients With Malignant Mesothelioma of the Lung
Erlotinib in Treating Patients With Malignant Mesothelioma of the Lung
For Condition: epithelial mesothelioma,recurrent malignant mesothelioma,sarcomatous mesothelioma,advanced malignant mesothelioma
Status: No longer recruiting
Sponsor(s): Southwest Oncology Group , National Cancer Institute (NCI)
Synopsis: RATIONALE: Erlotinib may interfere with the growth of tumor cells and slow the growth of the tumor. PURPOSE: Phase II trial to study the effectiveness of erlotinib in treating patients who have unresectable malignant mesothelioma of the lung.
Details: OBJECTIVES: - Determine the 1-year survival rate in patients with unresectable malignant pleural mesothelioma treated with erlotinib. - Determine the response rate in patients with measurable disease treated with this drug. - Determine the frequency and severity of toxic effects of this drug in these patients. - Measure epidermal growth factor receptor (EGFR) expression, EGFR gene amplification, and other activation products in the EGFR signaling pathway in tumor samples and correlate with clinical outcomes in patients treated with this drug. OUTLINE: This is a multicenter study. Patients receive oral erlotinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 6 months for 2 years and then annually for 1 year. PROJECTED ACCRUAL: A total of 55 patients will be accrued for this study within 14-18 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed malignant pleural mesothelioma - Epithelial - Sarcomatous - Biphasic - Measurable or nonmeasurable disease - Not amenable to extrapleural pneumonectomy - No known CNS metastases PATIENT CHARACTERISTICS: Age: - Not specified Performance status: - Zubrod 0-1 Life expectancy: - Not specified Hematopoietic: - WBC at least 3,000/mm^3 - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic: - Bilirubin no greater than 1.5 times upper limit of normal (ULN) - SGOT or SGPT no greater than 1.5 times ULN (5 times ULN if liver involvement of tumor) Renal: - Creatinine no greater than 2 times ULN Gastrointestinal: - No gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation - No active peptic ulcer disease - No intractable nausea or vomiting - Must be able to swallow and/or receive enteral medications via gastrostomy feeding tube Ophthalmic: - No known history of the following: - Dry eye syndrome - Sjogren's syndrome - Keratoconjunctivitis sicca - Exposure keratopathy - Fuch's dystrophy - Other active disorders of the cornea Other: - Not pregnant or nursing - Fertile patients must use effective contraception - No HIV-positive patients receiving combination antiretroviral therapy - No other prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or stage I or II cancer that is in complete remission PRIOR CONCURRENT THERAPY: Biologic therapy: - No prior biologic therapy for this tumor Chemotherapy: - No prior chemotherapy for this tumor Endocrine therapy: - Not specified Radiotherapy: - See Disease Characteristics - At least 3 weeks since prior radiotherapy and recovered Surgery: - See Disease Characteristics - At least 4 weeks since prior major surgery (e.g., thoracotomy or laparotomy), excluding minor surgeries (e.g., mediastinoscopy, thoracoscopy, or minor biopsies) - Recovered from prior surgery - No prior surgical procedures affecting absorption Other: - No prior investigational anticancer agents for this tumor
Total Enrollment:
Location and Contact Information:
Overall Study Official:
LindaGarland, Study Chair, Arizona Cancer Center
Veterans Affairs Medical Center - Portland
Portland, Oregon, 97207
United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201-1379
United States
Arizona Cancer Center
Tucson, Arizona, 85724
United States
Medical University of South Carolina
Charleston, South Carolina, 29425-0721
United States
Albert B. Chandler Medical Center, University of Kentucky
Lexington, Kentucky, 40536-0084
United States
Veterans Affairs Medical Center - Denver
Denver, Colorado, 80220
United States
CCOP - Santa Rosa Memorial Hospital
Santa Rosa, California, 95403
United States
Keesler Medical Center - Keesler AFB
Keesler AFB, Mississippi, 39534-2576
United States
Veterans Affairs Medical Center - Detroit
Detroit, Michigan, 48201-1932
United States
Swedish Cancer Institute
Seattle, Washington, 98104
United States
Barrett Cancer Center
Cincinnati, Ohio, 45267-0501
United States
Veterans Affairs Medical Center - Tucson
Tucson, Arizona, 85723
United States
CCOP - St. Louis-Cape Girardeau
St. Louis, Missouri, 63141
United States
Veterans Affairs Medical Center - Houston
Houston, Texas, 77030
United States
David Grant Medical Center
Travis Air Force Base, California, 94535
United States
CCOP - Dayton
Kettering, Ohio, 45429
United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
United States
Brooke Army Medical Center
Fort Sam Houston, Texas, 78234-6200
United States
Veterans Affairs Medical Center - Chicago (Westside Hospital)
Chicago, Illinois, 60612
United States
MBCCOP - Howard University Cancer Center
Washington D.C., District of Columbia, 20060
United States
Veterans Affairs Medical Center - Lexington
Lexington, Kentucky, 40502-2236
United States
CCOP - Southeast Cancer Control Consortium
Winston Salem, North Carolina, 27104-4241
United States
Veterans Affairs Medical Center - Boston (Jamaica Plain)
Jamaica Plain, Massachusetts, 02130
United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195-9001
United States
Huntsman Cancer Institute
Salt Lake City, Utah, 84112-5550
United States
Veterans Affairs Medical Center - Salt Lake City
Salt Lake City, Utah, 84148
United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78284-7845
United States
MBCCOP - Gulf Coast
Mobile, Alabama, 36688
United States
University of Colorado Cancer Center
Denver, Colorado, 80010
United States
CCOP - Montana Cancer Consortium
Billings, Montana, 59101
United States
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, 43210-1240
United States
Chao Family Comprehensive Cancer Center
Orange, California, 92868
United States
Veterans Affairs Medical Center - Oklahoma City
Oklahoma City, Oklahoma, 73104
United States
Herbert Irving Comprehensive Cancer Center
New York City, New York, 10032
United States
CCOP - Bay Area Tumor Institute
Oakland, California, 94609-3305
United States
Veterans Affairs Medical Center - Shreveport
Shreveport, Louisiana, 71130
United States
University of Rochester Medical Center
Rochester, New York, 14642
United States
Veterans Affairs Medical Center - Charleston
Charleston, South Carolina, 29401-5799
United States
Baylor College of Medicine
Houston, Texas, 77030
United States
MBCCOP - University of New Mexico HSC
Albuquerque, New Mexico, 87131
United States
Veterans Affairs Medical Center - Little Rock (McClellan)
Little Rock, Arkansas, 72205
United States
Texas Tech University Health Science Center
Lubbock, Texas, 79415
United States
Veterans Affairs Medical Center - Albany
Albany, New York, 12208
United States
Henry Ford Hospital
Detroit, Michigan, 48202
United States
St. Louis University Health Sciences Center
St. Louis, Missouri, 63110
United States
Oklahoma Medical Research Foundation
Oklahoma City, Oklahoma, 73104
United States
CCOP - Greenville
Greenville, South Carolina, 29615
United States
Veterans Affairs Outpatient Clinic - Martinez
Martinez, California, 94553
United States
Oregon Cancer Institute
Portland, Oregon, 97239
United States
Western New York Urology Associates
Buffalo, New York, 14220
United States
Tripler Army Medical Center
Honolulu, Hawaii, 96859-5000
United States
Veterans Affairs Medical Center - New Orleans
New Orleans, Louisiana, 70112
United States
Loyola University Medical Center
Maywood, Illinois, 60153-5500
United States
CCOP - Beaumont
Royal Oak, Michigan, 48073-6769
United States
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, 65807
United States
Tulane University School of Medicine
New Orleans, Louisiana, 70112
United States
City of Hope Comprehensive Cancer Center
Duarte, California, 91010
United States
Veterans Affairs Medical Center - Biloxi
Biloxi, Mississippi, 39531-2410
United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
United States
CCOP - Scott and White Hospital
Temple, Texas, 76508
United States
Veterans Affairs Medical Center - Kansas City
Kansas City, Missouri, 64128
United States
Veterans Affairs Medical Center - Phoenix (Carl T. Hayden)
Phoenix, Arizona, 85012
United States
CCOP - Columbus
Columbus, Ohio, 43206
United States
Veterans Affairs Medical Center - Dayton
Dayton, Ohio, 45428
United States
Veterans Affairs Medical Center - Wichita
Wichita, Kansas, 67218
United States
Veterans Affairs Medical Center - Jackson
Jackson, Mississippi, 39216
United States
Providence Hospital - Southfield
Southfield, Michigan, 48075-9975
United States
Eastern Virginia Medical School
Norfolk, Virginia, 23510-1115
United States
University of California Davis Medical Center
Sacramento, California, 95817
United States
CCOP - Northwest
Tacoma, Washington, 98405-0986
United States
CCOP - Atlanta Regional
Atlanta, Georgia, 30342-1701
United States
Boston Medical Center
Boston, Massachusetts, 02118
United States
CCOP - Greater Phoenix
Phoenix, Arizona, 85006-2726
United States
Louisiana State University Health Sciences Center - Shreveport
Shreveport, Louisiana, 71130-3932
United States
CCOP - Columbia River Program
Portland, Oregon, 97225
United States
CCOP - Virginia Mason Research Center
Seattle, Washington, 98101
United States
CCOP - Ann Arbor Regional
Ann Arbor, Michigan, 48106
United States
CCOP - Grand Rapids
Grand Rapids, Michigan, 49503
United States
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, 35294-3300
United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4095
United States
Veterans Affairs Medical Center - Seattle
Seattle, Washington, 98108
United States
MBCCOP - University of Illinois at Chicago
Chicago, Illinois, 60612-7323
United States
Veterans Affairs Medical Center - San Antonio (Murphy)
San Antonio, Texas, 78284
United States
Veterans Affairs Medical Center - Ann Arbor
Ann Arbor, Michigan, 48105
United States
CCOP - Upstate Carolina
Spartanburg, South Carolina, 29303
United States
Cancer Research Center of Hawaii
Honolulu, Hawaii, 96813-2424
United States
Dwight David Eisenhower Army Medical Center
Fort Gordon, Georgia, 30905-5650
United States
Veterans Affairs Medical Center - Albuquerque
Albuquerque, New Mexico, 87108-5138
United States
Veterans Affairs Medical Center - West Los Angeles
Los Angeles, California, 90073
United States
CCOP - Wichita
Wichita, Kansas, 67214-3882
United States
University of Texas Medical Branch
Galveston, Texas, 77555-0565
United States
CCOP - Duluth
Duluth, Minnesota, 55805
United States
MBCCOP - LSU Medical Center
New Orleans, Louisiana, 70112
United States
Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
Hines, Illinois, 60141
United States
Madigan Army Medical Center
Tacoma, Washington, 98431-5000
United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109-0912
United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216-4505
United States
Veterans Affairs Medical Center - Cincinnati
Cincinnati, Ohio, 45220-2288
United States
Veterans Affairs Medical Center - Temple
Temple, Texas, 76504
United States
CCOP - Kansas City
Kansas City, Missouri, 64131
United States
CCOP - Central Illinois
Decatur, Illinois, 62526
United States
Additional Information:
Study ID Numbers: CDR0000069360; SWOG-S0218
Study Start Date:
Record last reviewed: April 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00039182
Other Epithelial Mesothelioma Studies:
1. SU5416 in Treating Patients With Malignant Mesothelioma
2. Erlotinib in Treating Patients With Malignant Mesothelioma of the Lung
3. Surgery and Photodynamic Therapy in Treating Patients With Malignant Mesothelioma
4. ZD 1839 in Treating Patients With Malignant Mesothelioma
5. PTK787/ZK 222584 in Treating Patients With Unresectable Malignant Mesothelioma
Related Studies:
Other epithelial mesothelioma Clinical Trials
Other Massachusetts Clinical Trials
Other Jamaica Plain Clinical Trials
Erlotinib in Treating Patients With Malignant Mesothelioma of the Lung
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