Phase I/II study of combination chemotherapy with cisplatin, carboplatin and etoposide in small cell lung cancer.

A Phase I/II study of combination chemotherapy with cisplatin (CDDP), carboplatin (CBDCA) and etoposide (VP-16) (CPVP) was conducted in patients with small cell lung cancer. The dose level of etoposide was fixed at 100 mg/m2, while the doses of CDDP and CBDCA administered at each of the four steps were 50/200, 60/200, 60/250 and 70/250 mg/m2, respectively. Nine patients were allocated to each step dose group. Adverse effects were evaluated during the first two courses to establish the maximum tolerated dose (MTD). As a result, the step 3 doses turned out to be the MTD. The dose-limiting factor was hematotoxicity. Gastrointestinal toxicity was also present, but was tolerated. The overall response rate in patients with measurable or evaluable lesions was 91%. In 22 chemotherapy-naive patients, the median survival time was 16.6 months. These results suggest that the recommended dose is step 2, and that the CPVP regimen might be both more tolerable and more effective than the standard PVP regimen. Based on the above findings, CPVP therapy warrants further study in Phase II and III trials.