NCT01007552

A Study of Gemcitabine, Capecitabine and Bevacizumab to Treat Cancer of the Gall Bladder or Bile Ducts

A Multicenter Phase II Study of Gemcitabine, Capecitabine and Bevacizumab for Locally Advanced or Metastatic Adenocarcinoma of the Gall Bladder or Biliary Ducts.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Roswell Park Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To assess the proposed therapy for patients with advanced gallbladder or biliary cancers.

Detailed description

The primary objective of this study is to assess progression free survival with proposed therapy for patients with locally advanced or metastatic adenocarcinoma of the gallbladder or biliary ducts.

Conditions

• Cholangiocarcinoma

Interventions

Type	Name	Description
DRUG	Gemcitabine, Capecitabine and Bevacizumab	Bevacizumab 15 mg/ kg every 3 weeks, starting day 1; Capecitabine 650 mg/m2 bid x 14 days starting day 1, Gemcitabine 1000 mg/m2 days 1 and 8, cycles to be repeated every 21 days.

Timeline

• Start date: 2009-12-01
• Primary completion: 2015-05-01
• Completion: 2015-05-01
• First posted: 2009-11-04
• Last updated: 2017-03-29
• Results posted: 2017-03-29

Locations

2 sites across 1 country: United States