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Clinical Trial
. 2011 Dec;68(6):1595-602.
doi: 10.1007/s00280-011-1657-1. Epub 2011 May 10.

A phase II trial of gemcitabine and capecitabine in patients with unresectable or metastatic gallbladder cancer or cholangiocarcinoma: Southwest Oncology Group study S0202

Syma Iqbal  1 , Cathryn Rankin, Heinz-Josef Lenz, Philip J Gold, Syed A Ahmad, Anthony B El-Khoueiry, Michael J Messino, Randall F Holcombe, Charles D Blanke
Affiliations
Clinical Trial

A phase II trial of gemcitabine and capecitabine in patients with unresectable or metastatic gallbladder cancer or cholangiocarcinoma: Southwest Oncology Group study S0202

Syma Iqbal et al. Cancer Chemother Pharmacol. 2011 Dec.

Abstract

Purpose: Patients with gallbladder cancer or cholangiocarcinoma were treated with the combination of gemcitabine 1,000 mg/m(2) IV over 100 min on days 1 and 8 and capecitabine 650 mg/m(2) BID PO on days 1-14, administered every 21 days.

Methods: 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.

Results: 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).

Conclusions: The combination of gemcitabine and capecitabine is a well-tolerated regimen with activity in patients with advanced gallbladder cancer and cholangiocarcinoma.

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Figures

Figure 1
Figure 1
Kaplan-Meier Curve for overall survival in patients with unresectable or metastatic gallbladder cancer or cholangiocarcinoma treated with gemcitabine and capecitabine
Figure 2
Figure 2
Overall survival by TS5 status in patients with unresectable or metastatic gallbladder cancer or cholangiocarcinoma treated with gemcitabine and capecitabine
See this image and copyright information in PMC

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