A Phase I Study of Tirapazamine/Cisplatin/Etoposide and Concurrent Thoracic Radiotherapy for Limited Stage Small Cell Lung Cancer

Patients must have histologically or cytologically confirmed diagnosis of limited small cell lung cancer; diagnosis on the basis of sputum cytology is acceptable if confirmation by an independent pathologic review at the institution is documented; pts. with any brain mets are ineligible (all patients must have a pretreatment CT or MRI of the brain to evaluate for CNS disease); pts. with malignant pericardial effusions and malignant pleural effusions are ineligible (these are defined as either cytologically positive effusions OR exudative effusions not attributable to other etiologies); pts. must have serum creatinine <= IULN or a creatinine clearance >= 60 cc/min, ANC > 1,500/ul, PLT > 100,000/ul, adequate hepatic function documented by serum bilirubin <= 1.5 x IULN and liver enzymes SGOT/SGPT and ALK PHOS <= 2 x IULN; PS 0-1; no prior systemic chemo, thoracic RT or bio therapy for SCLC; at least two weeks must have elapsed since surgery (thoracic or other major surgeries) and meas or non-meas dz must be present outside the area of surgical resection; pts. with significant clinical hearing loss must be willing to accept the potential for worsening of symptoms; pts. must not have >= Grade 1 symptomatic neuropathy-sensory; following completion of induction therapy, pts. for whom there is no evidence of dz progression or mets (per Section 7.6a) and the restaging CXR or scan has been performed w/in 28 days of last induction RT tx, are eligible for Registration 2 (consolidation chemo) per Sections 5.18 and 5.19.