Chemotherapy and Radiation Therapy With or Without Efaproxiral in Treating Patients With Stage III Non-Small Cell Lung Cancer
Lung Cancer
About this trial
This is an interventional treatment trial for Lung Cancer focused on measuring stage IIIB non-small cell lung cancer, stage IIIA non-small cell lung cancer, adenocarcinoma of the lung, squamous cell lung cancer, large cell lung cancer
Eligibility 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
Sites / Locations
- St. Joseph's Hospital and Medical Center
- North Idaho Cancer Center
- Cancer Center at Lexington Clinic
- Willis - Knighton Cancer Center
- St. Agnes Cancer Center
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Providence Everett Medical Center - Pacific Campus
- Schiffler Cancer Center
- Algemeen Ziekenhuis Middelheim
- Tom Baker Cancer Center - Calgary
- Cross Cancer Institute
- Cancer Care Ontario-London Regional Cancer Centre
- Ottawa Regional Cancer Centre
- CHUS-Hopital Fleurimont
- Maisonneuve-Rosemont Hospital
- Hopital Notre- Dame du CHUM
- McGill University
- Centre Hospitalier Universitaire de Quebec
- Soroka University Medical Center
- Rambam Medical Center
- Sheba Medical Center
- Tel-Aviv Sourasky Medical Center