A phase II trial of gemcitabine and capecitabine in patients with unresectable or metastatic gallbladder cancer or cholangiocarcinoma: Southwest Oncology Group study S0202
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Patients with gallbladder cancer or cholangiocarcinoma were treated with the combination of gemcitabine 1,000 mg/m2 IV over 100 min on days 1 and 8 and capecitabine 650 mg/m2 BID PO on days 1–14, administered every 21 days.
The primary objective of this study was to assess the response rate (confirmed complete and partial responses) of gemcitabine and capecitabine used in advanced/metastatic biliary neoplasms. Secondary objectives included overall survival and toxicities.
The study accrued 57 patients from September 2003 to April 2005. Three patients were ineligible, and two others received no treatment. Characteristics of analyzable patients: 35 (67%) cholangiocarcinoma, 17 (33%) gallbladder cancer; PS 0 (18 pts), 1 (26 pts), 2 (8 pts); 26 (50%) men; median age 58.8 years (29.5–85.6). Among 51 patients evaluated for toxicity, 6 experienced grade 4 toxicities. Among 52 patients, there were 7 confirmed partial responses for a confirmed response probability of 13% (95% CI: 6–26%). Six patients had an unconfirmed partial response for an overall response probability of 25% (95% CI: 14–39%). Twelve patients (23%) demonstrated stable disease. The 6-month overall survival was 55% (95% CI: 41–69%), and median survival was 7 months (95% CI: 5–8 months).
The combination of gemcitabine and capecitabine is a well-tolerated regimen with activity in patients with advanced gallbladder cancer and cholangiocarcinoma.
KeywordsGemcitabine Capecitabine Cholangiocarcinoma Gallbladder Clinical trial
Support: This investigation was supported in part by the following Public Health Service Cooperative Agreement grant numbers awarded by the National Cancer Institute, Department of Health and Human Services: CA32102, CA38926, CA20319, CA58882, CA45808, CA58723, CA35176, CA76132, CA46441, CA63844, CA35178, CA58658, CA67575, CA45560, CA11083, CA46113, CA35128, CA58861, CA46368, CA35261, CA58416, CA42777, and CA35431 and supported in part by Roche.
Conflict of interest
Dr. Charles Blanke has consultant/advisory role for Roche Pharmaceuticals; Dr. El-Khoueiry has a consultant/advisory role and funding from Genentech.
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