Gefitinib and Sirolimus in Treating Patients With Recurrent or Refractory Stage IIIB or Stage IV Non-Small Cell Lung Cancer
Lung Cancer
About this trial
This is an interventional treatment trial for Lung Cancer focused on measuring recurrent non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed non-small cell lung cancer Stage IIIB or IV disease Recurrent or refractory disease Received ≥ 1 prior platinum-containing chemotherapy regimen Unidimensionally measurable disease that has not been irradiated No newly diagnosed untreated brain metastases or spinal cord compression Paraffin-embedded tumor tissue or slides available PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-2 Life expectancy Not specified Hematopoietic Adequate bone marrow function Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Hepatic Adequate hepatic function No severe or uncontrolled hepatic disease Renal Adequate renal function Creatinine ≤ 3.0 times upper limit of normal No severe or uncontrolled renal disease Cardiovascular Adequate cardiac function No severe or uncontrolled cardiac disease No uncontrolled hyperlipidemia Pulmonary No unstable or uncompensated respiratory disease No clinically active interstitial lung disease Patients with chronic stable radiographic changes who are asymptomatic are eligible Gastrointestinal Able to take oral medication No gastrointestinal condition (e.g., peptic ulcer disease) that would affect absorption Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No serious infection No known severe hypersensitivity to gefitinib or any of its excipients No other malignancy within the past 5 years except treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix No other severe or uncontrolled systemic disease No significant clinical disorder or laboratory finding that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy More than 14 days since prior biologic therapy No prior cetuximab, panitumumab, or bevacizumab Chemotherapy See Disease Characteristics More than 4 weeks since prior cytotoxic chemotherapy Endocrine therapy Not specified Radiotherapy See Disease Characteristics More than 3 weeks since prior radiotherapy No concurrent radiotherapy Surgery Recovered from prior oncologic or other major surgery No prior gastrointestinal surgery affecting absorption No concurrent surgery, including ophthalmic surgery, during and for 1 week after study treatment Other Recovered from all prior therapy More than 30 days since prior investigational agents No other prior HER1/epidermal growth factor receptor axis agents, including the following: Gefitinib Erlotinib CI-1033 Lapatinib No other prior vascular endothelial growth factor axis agents, including the following: ZD6474 Vatalanib No concurrent CYP3A4 inducers, including the following: Phenytoin Carbamazepine Rifampin Phenobarbital Barbiturates Hypericum perforatum (St. John's wort) No other concurrent systemic treatment for the malignancy No concurrent bisphosphonates for symptomatic bone metastases No concurrent systemic retinoids