Gefitinib and Radiation Therapy in Treating Patients With Inoperable Stage I or Stage II Non-Small Cell Lung Cancer
Non-small Cell Lung Cancer
About this trial
This is an interventional treatment trial for Non-small Cell Lung Cancer focused on measuring stage I non-small cell lung cancer, stage II non-small cell lung cancer, adenosquamous cell lung cancer, bronchoalveolar cell lung cancer, large cell lung cancer, squamous cell lung cancer, adenocarcinoma of the lung
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed non-small cell lung cancer (NSCLC) Any non-small cell histology allowed T1-3, N0* disease No metastatic disease Refused or ineligible for surgery Measurable disease, defined as lesion diameter ≤ 5 cm NOTE: *No evidence of N1 or N2 disease by positron emission tomography (PET) scan or any histological means (mediastinoscopy, thoracotomy, transbronchial, tracheal aspirations, or transesophageal aspiration by endoscopic ultrasound guidance PATIENT CHARACTERISTICS: Performance status Any performance status Life expectancy At least 1 year Hematopoietic No restrictions Hepatic No restrictions Renal Creatinine ≤ CTC grade 2 Pulmonary No clinically active interstitial lung disease Chronic, stable, asymptomatic radiographic changes allowed Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective nonhormonal contraception No known severe hypersensitivity to gefitinib or any of the excipients of this product No other malignancy within the past 5 years except basal cell cancer or carcinoma in situ of the cervix No active or uncontrolled infection No uncontrolled systemic disease No psychiatric illness or other severe medical condition that would preclude study participation PRIOR CONCURRENT THERAPY: Chemotherapy No prior chemotherapy Radiotherapy No prior radiotherapy to the chest or mediastinum No concurrent elective nodal irradiation Surgery Recovered from prior surgery No concurrent ophthalmic surgery Other Recovered from all other prior anticancer therapy (alopecia allowed) More than 30 days since prior nonapproved or investigational agents No concurrent CYP3A4 inducers, including any of the following: Phenytoin Carbamazepine Barbiturates Rifampin Phenobarbital Hypericum perforatum (St. John's wort) No concurrent systemic retinoids