Clinical Trial: Gemcitabine and Cisplatin for Gallbladder and Biliary Tract Cancer

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase II Trial of Gemcitabine and Cisplatin In Unresectable Or Metastatic Biliary Tract and Gallbladder Cancer

Brief Summary: In the United States, the incidence of biliary tract cancer and gallbladder cancer has been estimated to be 6,000-8,000 patients per year. Currently, there is no standard therapy for these tumors once the disease has spread and is inoperable. Recent small studies with gemcitabine have shown a positive response rate. The investigators plan to test the combination of gemcitabine with cisplatin for biliary tract and gallbladder cancers.

Detailed Summary: Gemcitabine and cisplatin will be administered weekly for two weeks (on day 1 and day 8) followed by a one week rest period (1 cycle is 3 weeks). On day one and eight of each cycle the patient will have a physical exam and blood work. During the first two cycles, additional blood work will be drawn on day 15 as well. Reassessment of the tumor will be performed at 6 weeks, 12 weeks, and every 9 weeks thereafter. Patients will remain on treatment until further evidence of disease progression or unacceptable side effects occur.
Sponsor: Dana-Farber Cancer Institute

Current Primary Outcome: To determine the response rate of the combination gemcitabine and cisplatin in patients with advanced biliary tract and gallbladder cancers

Original Primary Outcome: To determine the response rate of the combination gemcitabine and cisplatin in patients with advanced biliary tract and gallbladder cancers.

Current Secondary Outcome:

  • To determine the overall survival rate, progression-free survival rate, time to progression and duration of response
  • To determine the toxicity of gemcitabine and cisplatin
  • To assess the biomarker CA 19-9 response to the regimen and to correlate the CA 19-9 response with radiologic response and survival


Original Secondary Outcome:

  • To determine the overall survival rate, progression-free survival rate, time to progression and duration of response
  • To determine the toxicity of gemcitabine and cisplatin
  • to assess the biomarker CA 19-9 response to regimen and to correlate the CA 19-9 response with radiologic response and survival.


Information By: Dana-Farber Cancer Institute

Dates:
Date Received: July 25, 2005
Date Started: July 2002
Date Completion:
Last Updated: December 20, 2007
Last Verified: December 2007