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 Blanke

Research output: Contribution to journalArticle

25 Citations (Scopus)

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
Externally publishedYes

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gemcitabine
Gallbladder Neoplasms
Oncology
Cholangiocarcinoma
Toxicity
Survival
Capecitabine

Keywords

  • Capecitabine
  • Cholangiocarcinoma
  • Clinical trial
  • Gallbladder
  • Gemcitabine

ASJC Scopus subject areas

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

Cite this

A phase II trial of gemcitabine and capecitabine in patients with unresectable or metastatic gallbladder cancer or cholangiocarcinoma : Southwest Oncology Group study S0202. / Iqbal, Syma; Rankin, Cathryn; Lenz, Heinz Josef; Gold, Philip J.; Ahmad, Syed A.; El-Khoueiry, Anthony B.; Messino, Michael J.; Holcombe, Randall F.; Blanke, Charles.

In: Cancer Chemotherapy and Pharmacology, Vol. 68, No. 6, 12.2011, p. 1595-1602.

Research output: Contribution to journalArticle

Iqbal, Syma ; Rankin, Cathryn ; Lenz, Heinz Josef ; Gold, Philip J. ; Ahmad, Syed A. ; El-Khoueiry, Anthony B. ; Messino, Michael J. ; Holcombe, Randall F. ; Blanke, Charles. / A phase II trial of gemcitabine and capecitabine in patients with unresectable or metastatic gallbladder cancer or cholangiocarcinoma : Southwest Oncology Group study S0202. In: Cancer Chemotherapy and Pharmacology. 2011 ; Vol. 68, No. 6. pp. 1595-1602.
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title = "A phase II trial of gemcitabine and capecitabine in patients with unresectable or metastatic gallbladder cancer or cholangiocarcinoma: Southwest Oncology Group study S0202",
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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author = "Syma Iqbal and Cathryn Rankin and Lenz, {Heinz Josef} and Gold, {Philip J.} and Ahmad, {Syed A.} and El-Khoueiry, {Anthony B.} and Messino, {Michael J.} and Holcombe, {Randall F.} and Charles Blanke",
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T1 - A phase II trial of gemcitabine and capecitabine in patients with unresectable or metastatic gallbladder cancer or cholangiocarcinoma

T2 - Southwest Oncology Group study S0202

AU - Iqbal, Syma

AU - Rankin, Cathryn

AU - Lenz, Heinz Josef

AU - Gold, Philip J.

AU - Ahmad, Syed A.

AU - El-Khoueiry, Anthony B.

AU - Messino, Michael J.

AU - Holcombe, Randall F.

AU - Blanke, Charles

PY - 2011/12

Y1 - 2011/12

N2 - 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.

AB - 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.

KW - Capecitabine

KW - Cholangiocarcinoma

KW - Clinical trial

KW - Gallbladder

KW - Gemcitabine

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DO - 10.1007/s00280-011-1657-1

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