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, Cathryn Rankin, Heinz Josef Lenz, Philip J. Gold, Syed A. Ahmad, Anthony B. El-Khoueiry, Michael J. Messino, Randall F. Holcombe, Charles D. Blanke

Research output: Contribution to journalArticle

26 Scopus citations

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.

Original languageEnglish (US)
Pages (from-to)1595-1602
Number of pages8
JournalCancer Chemotherapy and Pharmacology
Volume68
Issue number6
DOIs
StatePublished - Dec 2011

Keywords

  • Capecitabine
  • Cholangiocarcinoma
  • Clinical trial
  • Gallbladder
  • Gemcitabine

ASJC Scopus subject areas

  • Oncology
  • Toxicology
  • Pharmacology
  • Cancer Research
  • Pharmacology (medical)

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