Chemotherapy and Radiation Therapy With or Without Efaproxiral in Treating Patients With Stage III Non-Small Cell Lung Cancer

Inclusion Criteria

• •DISEASE CHARACTERISTICS:
• •Histologically or cytologically confirmed locally advanced, unresectable non-small cell lung cancer of 1 of the following subtypes:
• •* Adenocarcinoma
• •* Squamous cell carcinoma
• •* Large cell carcinoma
• •* Poorly differentiated carcinoma
• •Stage IIIA or IIIB
• •* T1 or T2, N2
• •* T3, N1 or N2
• •* T4, any N
• •* Any T, N3
• •Histological or cytological confirmation of at least 1 positive lymph node required if the largest mediastinal node that is the basis of stage III disease is less than 2.0 cm in diameter
• •Clinically or radiologically measurable disease of at least 2.0 cm
• •Partially resected stage IIIB disease allowed provided a measurable lesion remains
• •No pleural effusion that is bloody, cytologically positive, or re-accumulated after thoracentesis
• •No metastatic disease by CT scan or MRI
• •PATIENT CHARACTERISTICS:
• •Age
• •18 and over
• •Performance status
• •Karnofsky 70-100%
• •Life expectancy
• •Not specified
• •Hematopoietic
• •Hemoglobin at least 10 g/dL
• •WBC at least 3,000/mm\^3
• •Absolute granulocyte count at least 2,000/mm\^3
• •Platelet count at least 100,000/mm\^3
• •Hepatic
• •Bilirubin no greater than 1.5 times upper limit of normal (ULN)
• •AST and ALT no greater than 2.5 times ULN
• •Renal
• •Creatinine no greater than 1.5 mg/dL
• •Cardiovascular
• •No clinically active congestive heart failure
• •No unstable angina
• •No severe arrhythmia by ECG
• •Pulmonary
• •FVC and FEV\_1 at least 50% of normal
• •Resting oxygen saturation by pulse oximetry (SpO\_2) at least 90% on room air
• •Exercise SpO\_2 at least 90% on room air
• •Other
• •Not pregnant or nursing
• •Negative pregnancy test
• •Fertile female patients must use effective contraception during and for 30 days after study therapy
• •Male patients must use effective contraception during and for 90 days after study therapy
• •No loss of more than 10% of body weight within the past 3 months
• •No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
• •No significantly altered mental status or dementia that would preclude giving informed consent
• •No active infection
• •No other serious underlying medical condition that would preclude study participation
• •PRIOR CONCURRENT THERAPY:
• •Biologic therapy
• •More than 28 days since prior biologic therapy
• •No concurrent colony-stimulating factors (randomized phase only)
• •No biologic therapy during and for 1 month after study therapy
• •No immune response modifiers during and for 1 month after study therapy
• •Chemotherapy
• •No prior systemic chemotherapy
• •Endocrine therapy
• •No hormonal therapy during and for 1 month after study therapy
• •Radiotherapy
• •No prior thoracic radiotherapy
• •Surgery
• •See Disease Characteristics
• •No prior total surgical resection
• •Other
• •More than 28 days since prior investigational drugs or devices
• •No prior efaproxiral
• •No other cytotoxic therapy during and for 1 month after study therapy