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

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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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U2 - 10.1007/s00280-011-1657-1

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