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Sponsors and Collaborators: |
Southwest Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00039182 |
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.
Condition | Intervention | Phase |
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Malignant Mesothelioma |
Drug: erlotinib hydrochloride |
Phase II |
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 |
Study Start Date: | May 2002 |
Primary Completion Date: | June 2007 (Final data collection date for primary outcome measure) |
OBJECTIVES:
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.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed malignant pleural mesothelioma
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Gastrointestinal:
Ophthalmic:
No known history of the following:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Study Chair: | Linda Garland, MD | University of Arizona |
Study ID Numbers: | CDR0000069360, SWOG-S0218 |
Study First Received: | June 6, 2002 |
Last Updated: | January 28, 2009 |
ClinicalTrials.gov Identifier: | NCT00039182 History of Changes |
Health Authority: | United States: Federal Government |
advanced malignant mesothelioma recurrent malignant mesothelioma epithelial mesothelioma sarcomatous mesothelioma |
Erlotinib Mesothelioma Protein Kinase Inhibitors |
Adenoma Recurrence Neoplasms, Glandular and Epithelial |
Erlotinib Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Neoplasms, Mesothelial Mesothelioma |
Enzyme Inhibitors Protein Kinase Inhibitors Adenoma Pharmacologic Actions Neoplasms, Glandular and Epithelial |