Weekly paclitaxel and carboplatin against advanced transitional cell cancer after failure of a platinum-based regimen.

OBJECTIVE: Weekly administration of paclitaxel plus carboplatin is hypothesized to be an effective second-line treatment for advanced transitional cell cancer after failure of platinum-based regimen. In this phase 2 trial, we tested this hypothesis.

PATIENTS AND METHODS: Patients with advanced transitional cell cancer who showed evidence of progressive or recurrent disease after methotrexate, vinblastine, doxorubicin, and cisplatin (MVAC) therapy were eligible for this study. Weekly paclitaxel (80mg/m(2)) and carboplatin (AUC 2) were administered on days 1, 8, 15, 22, 29, and 36; the cycle was repeated every 7 wk until disease progression or intolerable toxicity (maximum 18 doses).

RESULTS: Thirty-five patients entered this study. Among the 31 patients who were assessable, 10 had an objective response (overall response rate: 32.3%, 95% confidence interval, 15.8-48.7%). The median progression-free survival (PFS) and median survival times were 3.7 and 7.9 mo, respectively. Among the 22 patients who received prior MVAC therapy for metastatic disease, 36% had an objective response; their median PFS and median survival times were 4.3 and 7.9 mo, respectively; neither survival time significantly differed from the survival time of those who received prior MVAC as adjuvant setting. Toxicities were mild except one toxic death due to neutropenic sepsis.

CONCLUSIONS: Weekly paclitaxel plus carboplatin was a manageable, active second-line treatment for advanced transitional cell cancer after failure of platinum-based therapy.