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A phase II study of irinotecan (CPT-11) and carboplatin in patients with previously untreated small cell lung cancer (SCLC): Preliminary results.

7286 Background: CPT-11 and Carboplatin have shown activity in SCLC. We are currently evaluating a combination of both drugs in a phase II trial.


METHODS
Elegible patients include those with a histological or cytological diagnosis of SCLC; no previous chemotherapy for metastatic SCLC; measurable disease; performance status OMS 0-2; life expectancy >3 months; adequate bone marrow, liver, and renal function, and written informed consent. Patients receive carboplatin at AUC of 5 over 2 hours followed by 50 mg/m2 of CPT-11, both on day 1. CPT-11 is readministered at the same dose on days 8 and 15. Chemotherapy cycles are repeated every 28 days for a maximum of 6 cycles. Response is assessed every 3 cycles. Primary endpoints are efficacy and toxicity, and secondary endpoints include time to progression and survival.


RESULTS
Of a planned 40 patients, 21 patients have been enrolled to date (males 100%). Of these, 7 were evaluable for response and 16 for toxicity. 149 infusions of CPT-11 have been administered (median 10 infusions, range 2-18). 16 infusions were delayed due to toxicity, primarily hematologic toxicity (75% of delays). In addition, 4 infusions required dose reduction, due to hematologic (50%) and non-hematologic toxicity (50%). Responses have been evaluated in 7 patients. 1 patient showed a complete response (14.29%) and 4 patients a partial response (57.14%). Disease was stabilized in 1 patient (14.3%) and 1 patient showed disease progression (14.3%). 50% of patients presented grade 3-4 toxicity, the most frequent grade 3 - 4 adverse events being: leucopenia (14.3%), neutropenia (14.3%), anemia (4.8%), liver transaminase (9.5%), alcaline phosphatase (9.5%), pulmonary toxicity (9.5%), pain (9.5%), infection (9.5%), asthenia (4.8%), and hemorrhage (4.8%).


CONCLUSIONS
Preliminary results suggest that this treatment schedule is feasible. Efficacy data are promising but more data are required. The study is ongoing. [Table: see text].