A Phase II Trial of BAY 43-9006 (NSC-724772) in Patients with Platinum-Treated Extensive Stage Small Cell Lung Cancer

Pts must have histologic or cytologically-confirmed SCLC extensive disease; Must have progression or recurrence after receiving a standard first-line regimen containing either cisplatin or carboplatin; Diagnosis based on sputum cytology alone is allowed if there is documented confirmation by an independent pathologic review; Pts must have been previously treated with exactly one regimen, which must have included either cisplatin or carboplatin; Pts must be deemed either platinum-sensitive (initial response then progression > 90 days after last platinum treatment) or platinum-refractory (no response then progression during or 90 days after completing treatment); Total bilirubin </= 2 x IULN and Alkaline phosphatase </= IULN and SGOT or SGPT </= 2 x IULN, Serum Creatinine </= IULN or Creatinine Clearance >/= 60 cc/min (measured or calculated), ANC >/= 1,500 and PLTS >/= 100,000; Previous RT must have been completed at least 21 days prior to registration and pt recovered from all toxicities; no plans for concurrent RT to measurable lesions; Measurable disease inside RT port allowed if there is progression; Pts must have measurable disease per RECIST criteria; Evidence of disease on X-ray, CT or MRI; At least 14 days from previous major surgery and recovered from all toxicities; Disease must be present outside the area of previous surgical resection or a new lesion must be present; PT or INR and PTT < 1.5 x IULN; Zubrod PS 0-1; Pts must not have prior malignancy except; treated basal cell or squamous cell skin ca, in situ cervical, Stage I or II ca in complete remission; disease-free from any ca for 5 yrs; Pts must not have significant history of cardiac disease e.g., uncontrolled HTN, unstable angina, CHF and MI w/in 6 months or ventricular arrhythmias requiring meds; Pts must not be unable to swallow and/or receive enteral meds via feeding tube; Pts must not have intractable nausea or vomiting, inability to take oral meds due to malabsorption syndrome, requirement for IV alimentation, prior surgery affecting absorption or uncontrolled inflammatory GI disease; Pts must not have symptomatic brain mets or be receiving systemic corticosteroid therapy to control symptoms or brain CT or MRI obtained > 28 days prior to registration; Pts must not have any ongoing requirement for systemic corticosteroid therapy; topical and/or inhaled steroids are allowed; Pts must not be pregnant or nursing or of reproductive potential and not agreed to use of effective contraceptive method; Pts must be willing to provide smoking history; Pts must be >/= 18 years of age; Institutions must have IRB approval of S9925 and patients must be offered participation in S9925. Register patients separately to receive institutional credit for specimens submission.