Erlotinib in Treating Patients With Malignant Mesothelioma of the Lung
Advanced Malignant Mesothelioma, Epithelial Mesothelioma, Recurrent Malignant Mesothelioma
About this trial
This is an interventional treatment trial for Advanced Malignant Mesothelioma
Eligibility Criteria
Inclusion Criteria: Histologically confirmed malignant pleural mesothelioma Epithelial Sarcomatous Biphasic Measurable or nonmeasurable disease Not amenable to extrapleural pneumonectomy No known CNS metastases Performance status - Zubrod 0-1 WBC at least 3,000/mm^3 Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 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) Creatinine no greater than 2 times ULN 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 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 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 No prior biologic therapy for this tumor No prior chemotherapy for this tumor See Disease Characteristics At least 3 weeks since prior radiotherapy and recovered 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 No prior investigational anticancer agents for this tumor
Sites / Locations
- Southwest Oncology Group
Arms of the Study
Arm 1
Experimental
Treatment (erlotinib hydrochloride)
Patients receive oral erlotinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.