The combination of carboplatin and weekly paclitaxel: a safe and active regimen in advanced non small-cell lung cancer patients. A phase I-II study.

The combination of carboplatin and paclitaxel given every three weeks is a tolerated and reasonably active regimen in advanced non-small cell lung cancer (NSCLC). This Study was designed to evaluate the maximum tolerated dose (MTD) of a fixed dose of carboplatin with an area under the Curve (AUC) of 6 and escalating doses of weekly paclitaxel with an initial dose of 50 mg/m(2) with 10 mg/m(2) increments at each level in untreated NSCLC patients (phase I study). The Study continued with a phase 11 study. Thirty patients entered the phase I study. The MTD was: carboplatin AUC=6 on days 1 and 28 plus paclitaxel 100 mg/m(2) (1 hour) on days 1,8,15,28. The dose-limiting toxicity (DLT) was severe neutropenia and cardiological toxicity. Subsequently, 42 patients entered the phase 11 study with the same treatment schedule. The 2-drug combination was globally well tolerated. The overall response rate (RR) was 42% [CI 95%: 26.3-57.7], stable disease (SD) 29% and progression (PD) 29%. The median duration of response was 8.0 mos (range: 1.0-19.0). The median time to progression was 8.0 mos (range: 7.0-19.0) and the median survival was 14.0 months (range: 9.0-19.0). The association of carboplatin AUC-6 and weekly paclitaxel 100 mg/m(2) proved to be manageable, active and extremely safe even in elderly patients (one third of all patients in our cohort). The survival results were interesting: the median survival time was 14 months (9-19 months) and the 1- and 2-year survival was 59% and 16%, respectively.