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 pati ents with small cell lung cancer. The dose level of etoposide was fixe d at 100 mg/m(2), while the doses of CDDP and CBDCA administered at ea ch of the four steps were 50/200, 60/200, 60/250 and 70/250 mg/m(2), r espectively. Nine patients were allocated to each step dose group. Adv erse 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. Gastr ointestinal 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, an d that the CPVP regimen might be both more tolerable and more effectiv e than the standard PVP regimen. Based on the above findings, CPVP the rapy warrants further study in Phase II and III trials.