Dose Finding Study of Carboplatin and Weekly Paclitaxel for Advanced Non-small Cell Lung Cancer.

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Purpose: This study aimed to determine the maximum tolerated doses of paclitaxel administered weekly in combination with a fixed dose of carboplatin, and to assess the toxicity and preliminary activity of this combination in patients with previously untreated, advanced non-small cell lung cancer. Patients and Methods: Fifteen patients (10 men and 5 women) were enrolled. The median age was 67 years (range 46 to 76 years). Carboplatin was administered on day 1 (area under the curve=6mg/ml·min), and paclitaxel was administered on days 1, 8, and 15. The starting dose of paclitaxel was 50mg/m2, which was increased in 10mg increments. Chemotherapy was repeated every 4 weeks. Results: Two of the three level 4 patients (paclitaxel 80mg/m2) experienced dose-limiting toxicities: one patient experienced neutropenic fever with grade 3 diarrhea; the other experienced grade 3 lethargy with grade 3 diarrhea and grade 3 hyponatremia, and the performance status of this patient gradually deteriorated. Thus, 80mg/m2 was defined as the maximum tolerated dose in this schedule. The objective response rate was 46.7%(7/15). Conclusion: The dose level of paclitaxel 70mg/m2 on days 1, 8, and 15 in combination with carboplatin AUC=6 on day 1 of a four week cycle was recommended for a phase II study.
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