Suramin, Paclitaxel, and Carboplatin in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer

PRIMARY OBJECTIVES: I. Determine the minimum effective dose of suramin that will reduce resistance to chemotherapy with paclitaxel and carboplatin in patients with stage IIIB or IV non-small cell lung cancer (phase I). (Phase I closed to accrual 1/29/02). II. Evaluate pharmacokinetic interactions of this drug combination in these patients (phase I). (Phase I closed to accrual 1/29/02). III. Determine the objective response rate in patients treated with this regimen (phase II \[chemotherapy-naive patients closed to accrual 9/1/03\]). IV. Determine the time to tumor progression, progression-free rate at 6 months, and 1-year survival of patients treated with this regimen (phase II \[chemotherapy-naive patients closed to accrual 9/1/03\]). OUTLINE: Patients in phase II are stratified according to prior treatment (chemotherapy naive \[closed to accrual 9/1/03\] vs chemotherapy refractory). Phase I (phase I closed to accrual 1/29/02): Patients receive suramin IV over 30 minutes on days 1 and 2. Patients also receive paclitaxel IV over 3 hours and carboplatin IV over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of suramin until the target dose is determined. The target dose is defined as the dose at which at least 5 of 6 patients achieve optimal plasma concentrations of suramin and no more than 1 of 6 patients exceed optimal level. Doses of paclitaxel are adjusted until the maximum tolerated dose in combination with suramin and paclitaxel is determined. Phase II (chemotherapy-naive patients closed to accrual 9/1/03): Patients receive the target dose of suramin IV over 30 minutes on days 1 and 2. Patients also receive paclitaxel IV over 3 hours and carboplatin IV over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3-6 weeks. PROJECTED ACCRUAL: Approximately 82 patients (18 for phase I \[phase I closed to accrual 1/29/02\] and 64 for phase II \[chemotherapy-naive patients closed to accrual 9/1/03\]) will be accrued for this study.