Gefitinib in Treating Patients With Malignant Mesothelioma
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 mesothelioma that is not amenable to curative surgery or radiotherapy Epithelial, sarcomatoid, or mixed subtype Any site of origin (including, but not limited to, the pleura, peritoneum, pericardium, or tunica vaginalis) allowed Measurable disease, defined as lesions that can be accurately measured in at least 1 dimension (longest diameter) as at least 20 mm with conventional techniques or at least 10 mm with spiral CT scan Must be outside prior radiation port Lesions not considered measurable include the following: Bone lesions Leptomeningeal disease Ascites Pleural/pericardial effusion Inflammatory breast disease Lymphangitis cutis/pulmonis Abdominal masses not confirmed and followed by imaging techniques Cystic lesions No known brain metastases Performance status - CTC 0-1 Granulocyte 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 no greater than 2.5 times ULN Creatinine no greater than 1.5 times ULN No symptomatic congestive heart failure No unstable angina pectoris No cardiac arrhythmia Not pregnant or nursing Fertile patients must use effective contraception No other concurrent active malignancy except nonmelanoma skin cancer Disease considered not currently active if completely treated with less than a 30% risk for relapse No other concurrent uncontrolled illness No ongoing or active infection No psychiatric illness or social situation that would preclude study compliance No prior epidermal growth factor receptor-inhibitor therapy Prior intrapleural cytotoxic or sclerosing agents (including bleomycin) allowed No prior systemic cytotoxic chemotherapy for malignant mesothelioma No concurrent chemotherapy At least 1 week since prior CYP3A4 inducers (e.g., dexamethasone, glucocorticoids, progesterone) No concurrent CYP3A4 inducers (e.g., dexamethasone) No concurrent hormonal therapy (e.g., tamoxifen) except steroids for adrenal failure or hormones for non disease-related conditions (e.g., insulin for diabetes) See Disease Characteristics At least 4 weeks since prior radiotherapy No concurrent radiotherapy, including for palliation See Disease Characteristics At least 2 weeks since prior major surgery At least 1 week since other prior CYP3A4 inducers (e.g., carbamazepine, ethosuximide, griseofulvin, nafcillin, nelfinavir mesylate, nevirapine, oxcarbazepine, phenobarbital, phenylbutazone, phenytoin, primidone, rifabutin, rifampin, rofecoxib, St. John's Wort, sulfadimidine, sulfinpyrazone, or troglitazone) No other concurrent CYP3A4 inducers No concurrent CYP3A4 substrates or inhibitors No other concurrent investigational agent No concurrent combination antiretroviral therapy for HIV-positive patients No concurrent chlorpromazine, amiodarone, or chloroquine
Sites / Locations
- Cancer and Leukemia Group B
Arms of the Study
Arm 1
Experimental
Treatment (gefitinib)
Patients receive oral gefitinib once daily on days 1-21. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.