A multi-institution phase II trial of irinotecan and carboplatin for extensive or relapsed small-cell lung cancer

Abstract

7169 Purpose: Combined irinotecan and platinum are emerging as a promising regimen for treatment of metastatic small-cell lung cancer (SCLC). We are conducting a multi-institution trial to evaluate the efficacy and toxicity of a novel 21-day schedule of irinotecan and carboplatin in extensive and relapsed SCLC. Methods: To date, 58 patients have enrolled with the following characteristics: male/female, 31/27; median age, 64 years; performance status (PS), 0–1 (81%), 2 (19%). Dosing schemas are based on population-based maximum tolerated doses determined in a previous intrapatient dose-escalation trial (Oncology 17:11–16, 2003). Patients with chemonaive extensive disease (Arm A) are treated with irinotecan 200 mg/m2 and carboplatin AUC of 5; while patients with previously chemotherapy-treated and relapsed disease (Arm B) received irinotecan 150 mg/m2 and carboplatin AUC of 5, every 21 days for 6 cycles. Forty patients are planned for each arm. Results: The most common grade 3/4 toxicity included neutropenia (38%), thrombocytopenia (14%), diarrhea (18%) and nausea/emesis (10%). Grade 3/4 toxicity was not observed in 54% of patients. Among 44 assessable patients, response rates of 68% and 37% were observed, respectively, for Arm A and Arm B. Of note, durable complete response of brain metastases was observed in some patients. Conclusions: The 3-weekly regimen of irinotecan and carboplatin is relatively well tolerated and promising for treatment of extensive or relapsed SCLC. This regimen warrants further evaluation in a phase III trial. No significant financial relationships to disclose.