Clinical Trial: Gemcitabine, Oxaliplatin in Combination With Bevacizumab in Biliary Tract and Gallbladder Cancer

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

Official Title: Phase II Study of Gemcitabine, Oxaliplatin in Combination With Bevacizumab (Avastin) in Unresectable or Metastatic Biliary Tract and Gallbladder Cancer

Brief Summary: The purposes of this study are to test the safety of bevacizumab when given in combination with gemcitabine and oxaliplatin and to see what effects (good and bad) this combination has on patients with cancer of bile duct or gallbladder. Bevacizumab has been shown to slow or stop cell growth in tumors by decreasing the blood supply to the tumors.

Detailed Summary:

  • The chemotherapy drugs are given twice every 28 days. This 28 day period is called a cycle of study treatment.
  • Bevacizumab will be administered by IV over 90 minutes on day 1 and day 15. Gemcitabine will be administered by IV over 1 hour and 40 minutes on days 1 and 15 of each cycle. Oxaliplatin will be administered by IV for 2 hours on days 1 and 15 of each cycle.
  • The following tests and procedures will be performed on day 1 and day 15 or each cycle: physical examination; medical history; blood work; and urine test. A PET scan will be repeated at the end of cycle 2 and CT scans will be repeated once every 8 weeks.
  • Participants will continue to receive cycles of study treatment as long as their disease does not progress and they are not experiencing any serious side effects.

Sponsor: Massachusetts General Hospital

Current Primary Outcome: Median Progression Free Survival [ Time Frame: 2 years ]

To assess the median progression free survival in patients with BTC on GEMOX-B. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. In addition, death in the absence of radiological disease progression was also categorized as progression.


Original Primary Outcome: To assess the progression free survival of GEMOX-B regimen in patients with unresectable or metastatic biliary tract and gallbladder adenocarcinoma.

Current Secondary Outcome: Overall Response Rate [ Time Frame: 2 years ]

To assess the overall response rate of GEMOX-B in patients with advanced BTC. Response rate is determined through Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.


Original Secondary Outcome:

  • To evaluate the toxicities of the GEMOX-B regimen in this population of patients
  • to assess the response rate, the duration of response and median survival of GEMOX-B in this patient population
  • to evaluate changes on PET scans with treatment and correlation of PET scan change with PFS, response and OS.


Information By: Massachusetts General Hospital

Dates:
Date Received: August 4, 2006
Date Started: May 2006
Date Completion:
Last Updated: December 14, 2016
Last Verified: December 2016