A phase II study of gemcitabine and docetaxel therapy in patients with advanced urothelial carcinoma
Year: 2003
Type: article
Study design: Clinical Trial
Abstract: BACKGROUND: The objectives of the current study were to evaluate the safety and efficacy of gemcitabine plus docetaxel in patients with unresectable (Stage T4 or >/= N1) metastatic or locally advanced transitional cell carcinoma (TCC) of the urothelial tract. METHODS: A total of 27 patients were enrolled in the current multisite study, which was performed within the University of California-Los Angeles Community Oncology Research Network. The first 10 patients in the study received 800 mg/m(2) of gemcitabine intravenously on Days 1, 8, and 15 of a 28-day treatment cycle. In addition, on Day 1, the first 10 patients received 80 mg/m(2) of docetaxel intravenously after completion of the gemcitabine infusion. Because of dose-limiting toxicity (neutropenia), the initial dose of docetaxel was reduced to 60 mg/m(2) for the remaining patients who entered the study (n = 17 patients). RESULTS: Neutropenia was the most common adverse event that occurred in patients at the Grade 3 level (in 10 of 27 patients; 37.0%) and the Grade 4 level (in 6 of 27 patients; 22.2%). There were no other adverse events at the Grade 4 toxicity level. Twenty-five of 27 patients (92.6%) completed more than 1 cycle of combination therapy and were evaluated for antitumor responses. The frequency of objective clinical responses was 33.3% (9 of 27 patients). Complete responses to therapy were observed in 2 of 27 patients (7.4%), and partial responses were observed in 7 of 27 patients (25.9%). The median duration of response was 20 weeks (range, 12+ weeks to 152 weeks). The median survival duration was 52 weeks (range, 12 weeks to 160+ weeks). Four of 27 patients (14.8%) remained alive at the time of the current data analysis. CONCLUSIONS: The results of the current study suggested that combination therapy with gemcitabine and docetaxel was an effective treatment for patients with unresectable (Stage T4 or >/= N1) metastatic or locally advanced TCC of the urothelial tract. Gemcitabine plus docetaxel appeared to be tolerated well, and treatment-related toxicities were limited to hematologic toxicities. Because cisplatin-containing regimens are contraindicated for patients with impaired renal function, the gemcitabine plus docetaxel combination may prove to be an effective and well tolerated treatment option for these patients.
Source: Cancer
DOI: 10.1002/cncr.11726
Authors: Barbara J. Gitlitz, Carole Baker, Yvonne Chapman, Heather J. Allen, Linda D. Bosserman, Ravi Patel, James D. Sanchez, Richard M. Shapiro, Robert A. Figlin
Language: English
Subfield: Surgery
Field: Medicine
Domain: Health Sciences
Open Access status: bronze
OpenAlex ID: W2028117648