Mesothelioma Related Clinical Trials:
A Phase II Study of Oral EGFR Tyrosine Kinase Inhibitor OSI-774 (NSC-718781) in Patients With Malignant Pleural Mesothelioma

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Status: Completed
Sponsors and Collaborators: Southwest Oncology Group, National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
Government Identifier: NCT00039182

Condition: Malignant Mesothelioma
Intervention: Drug: erlotinib hydrochloride; Procedure: protein tyrosine kinase inhibitor therapy

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Purpose:


RATIONALE: Erlotinib may interfere with the growth of tumor cells and slow the growth of the tumor.

PURPOSE: This phase II trial is studying how well erlotinib works in treating patients with malignant mesothelioma of the lung.

Study Type:   Interventional
Study Design:   Treatment
Official Title:   A Phase II Study of Oral EGFR Tyrosine Kinase Inhibitor OSI-774 (NSC-718781) in Patients With Malignant Pleural Mesothelioma

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

Study Start Date:   May 2002

Detailed Description:

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.

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Eligibility:

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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

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Contacts and Locations:

Please refer to this study by its ClinicalTrials.gov identifier: NCT00039182

Locations
United States, Alabama
MBCCOP - Gulf Coast    
      Mobile, Alabama, United States, 36688
University of Alabama at Birmingham Comprehensive Cancer Center    
      Birmingham, Alabama, United States, 35294-3300
United States, Arizona
Arizona Cancer Center    
      Tucson, Arizona, United States, 85724
Veterans Affairs Medical Center - Tucson    
      Tucson, Arizona, United States, 85723
Veterans Affairs Medical Center - Phoenix (Carl T. Hayden)    
      Phoenix, Arizona, United States, 85012
CCOP - Greater Phoenix    
      Phoenix, Arizona, United States, 85006-2726
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
CCOP - Bay Area Tumor Institute    
      Oakland, California, United States, 94609-3305
CCOP - Santa Rosa Memorial Hospital    
      Santa Rosa, California, United States, 95403
Chao Family Comprehensive Cancer Center    
      Orange, California, United States, 92868
City of Hope Comprehensive Cancer Center    
      Duarte, California, United States, 91010
David Grant Medical Center    
      Travis Air Force Base, California, United States, 94535
Jonsson Comprehensive Cancer Center, UCLA    
      Los Angeles, California, United States, 90095-1781
University of California Davis Medical Center    
      Sacramento, California, United States, 95817
Veterans Affairs Medical Center - West Los Angeles    
      Los Angeles, California, United States, 90073
Veterans Affairs Outpatient Clinic - Martinez    
      Martinez, California, United States, 94553
United States, Colorado
University of Colorado Cancer Center    
      Denver, Colorado, United States, 80010
Veterans Affairs Medical Center - Denver    
      Denver, Colorado, United States, 80220
United States, District of Columbia
MBCCOP - Howard University Cancer Center    
      Washington, District of Columbia, United States, 20060
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, 96813-2424
Tripler Army Medical Center    
      Honolulu, Hawaii, United States, 96859-5000
United States, Illinois
CCOP - Central Illinois    
      Decatur, Illinois, United States, 62526
Loyola University Medical Center    
      Maywood, Illinois, United States, 60153-5500
MBCCOP - University of Illinois at Chicago    
      Chicago, Illinois, United States, 60612-7323
Veterans Affairs Medical Center - Chicago (Westside Hospital)    
      Chicago, Illinois, United States, 60612
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
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, 40502-2236
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
Barbara Ann Karmanos Cancer Institute    
      Detroit, Michigan, United States, 48201-1379
CCOP - Ann Arbor Regional    
      Ann Arbor, Michigan, United States, 48106
CCOP - Beaumont    
      Royal Oak, Michigan, United States, 48073-6769
CCOP - Grand Rapids    
      Grand Rapids, Michigan, United States, 49503
Henry Ford Hospital    
      Detroit, Michigan, United States, 48202
Providence Hospital - Southfield    
      Southfield, Michigan, United States, 48075-9975
University of Michigan Comprehensive Cancer Center    
      Ann Arbor, Michigan, United States, 48109-0912
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, Minnesota
CCOP - Duluth    
      Duluth, Minnesota, United States, 55805
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
CCOP - St. Louis-Cape Girardeau    
      Saint Louis, Missouri, United States, 63141
CCOP - Kansas City    
      Kansas City, Missouri, United States, 64131
CCOP - Cancer Research for the Ozarks    
      Springfield, Missouri, United States, 65807
St. Louis University Health Sciences Center    
      Saint Louis, Missouri, United States, 63110
Veterans Affairs Medical Center - Kansas City    
      Kansas City, Missouri, United States, 64128
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
University of Rochester Medical Center    
      Rochester, New York, United States, 14642
Veterans Affairs Medical Center - Albany    
      Albany, New York, United States, 12208
Western New York Urology Associates    
      Buffalo, New York, United States, 14220
United States, North Carolina
CCOP - Southeast Cancer Control Consortium    
      Winston-Salem, North Carolina, United States, 27104-4241
United States, Ohio
CCOP - Columbus    
      Columbus, Ohio, United States, 43206
Barrett Cancer Center    
      Cincinnati, Ohio, United States, 45267-0501
Arthur G. James Cancer Hospital - Ohio State University    
      Columbus, Ohio, United States, 43210-1240
CCOP - Dayton    
      Kettering, Ohio, United States, 45429
Cleveland Clinic Taussig Cancer Center    
      Cleveland, Ohio, United States, 44195-9001
Veterans Affairs Medical Center - Cincinnati    
      Cincinnati, Ohio, United States, 45220-2288
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, 97225
Oregon Cancer Institute    
      Portland, Oregon, United States, 97239
Veterans Affairs Medical Center - Portland    
      Portland, Oregon, United States, 97207
United States, South Carolina
CCOP - Greenville    
      Greenville, South Carolina, United States, 29615
Veterans Affairs Medical Center - Charleston    
      Charleston, South Carolina, United States, 29401-5799
Medical University of South Carolina    
      Charleston, South Carolina, United States, 29425-0721
CCOP - Upstate Carolina    
      Spartanburg, South Carolina, United States, 29303
United States, Texas
University of Texas Health Science Center at San Antonio    
      San Antonio, Texas, United States, 78284-7845
Brooke Army Medical Center    
      Fort Sam Houston, Texas, United States, 78234-6200
CCOP - Scott and White Hospital    
      Temple, Texas, United States, 76508
Texas Tech University Health Science Center    
      Lubbock, Texas, United States, 79415
University of Texas - MD Anderson Cancer Center    
      Houston, Texas, United States, 77030-4095
Baylor College of Medicine    
      Houston, Texas, United States, 77030
University of Texas Medical Branch    
      Galveston, Texas, United States, 77555-0565
Veterans Affairs Medical Center - Houston    
      Houston, Texas, United States, 77030
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, 84112-5550
Veterans Affairs Medical Center - Salt Lake City    
      Salt Lake City, Utah, United States, 84148
United States, Virginia
Eastern Virginia Medical School    
      Norfolk, Virginia, United States, 23510-1115
United States, Washington
CCOP - Northwest    
      Tacoma, Washington, United States, 98405-0986
CCOP - Virginia Mason Research Center    
      Seattle, Washington, United States, 98101
Madigan Army Medical Center    
      Tacoma, Washington, United States, 98431-5000
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:     Linda Garland, MD     University of Arizona    

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Additional Information:

Publications of Results:
Garland LL, Rankin C, Gandara DR, Rivkin SE, Scott KM, Nagle RB, Klein-Szanto AJ, Testa JR, Altomare DA, Borden EC. Phase II study of erlotinib in patients with malignant pleural mesothelioma: a Southwest Oncology Group Study. J Clin Oncol. 2007 Jun 10;25(17):2406-13.
 
Garland L, Rankin C, Scott K, et al.: Molecular correlates of the EGFR signaling pathway in association with SWOG S0218: a phase II study of oral EGFR tyrosine kinase inhibitor OSI-774 (NSC-718781) in patients with malignant pleural mesothelioma (MPM). [Abstract] J Clin Oncol 22 (Suppl 14): A-3007, 196s, 2004.

Study ID Numbers:   CDR0000069360, SWOG-S0218
First Received:   June 6, 2002
Last Updated:   December 15, 2007
ClinicalTrials.gov Identifier:   NCT00039182
Health Authority:   United States: Federal Government

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

Study placed in the following topic categories:
Erlotinib
Mesothelioma
Adenoma
Recurrence
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Mesothelioma
Molecular Mechanisms of Pharmacological Action
Neoplasms, Mesothelial
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions

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