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

Part of paid clinical trials in Buffalo, New York.

Sponsor
Roswell Park Cancer Institute
Study ID
NCT01007552
Phase
PHASE2
Status
Completed

Conditions

  • Cholangiocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Gemcitabine, Capecitabine and Bevacizumab — DRUG
    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.

Study Details

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

Key Dates

First listed
Nov 4, 2009
Start date
Dec 31, 2009
Status verified
Feb 2017
Primary completion
May 31, 2015
Completion
May 31, 2015

Study Design

Enrollment
50 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Gemcitabine, Capecitabine and Bevacizumab
    Estimate the toxicity of the regimen, and estimate the quality of life (QOL).

Primary Outcome Measure

The Primary Objective of This Study is to Assess Progression Free Survival (PFS) With Proposed Therapy for Patients With Locally Advanced or Metastatic Gallbladder and Biliary Cancers. [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years ]

Locations (2)

FacilityCityStateZIPSite coordinators
Roswell Park Cancer InstituteBuffaloNew York14263-
Ohio State UniversityColumbusOhio43210-

Find similar trials in Buffalo, NY

By research site
Roswell Park Cancer Institute· Buffalo, NYOhio State University· Columbus, OH

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