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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT00361231
Phase
PHASE2
Status
Completed

Conditions

  • Biliary Tract Cancer
  • Gallbladder Adenocarcinoma

Eligibility Criteria

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

Interventions

  • Bevacizumab — DRUG
    Given intravenously on days 1 and 15 of each 28-day cycle. Participants may continue to receive study treatment as lond as their disease does not progress and they do not experience any serious side effects.
  • Gemcitabine — DRUG
    Given intravenously on days 1 and 15 of each 28-day cycle. Participants may continue to receive study treatment as lond as their disease does not progress and they do not experience any serious side effects.
  • Oxaliplatin — DRUG
    Given intravenously on days 1 and 15 of each 28-day cycle. Participants may continue to receive study treatment as lond as their disease does not progress and they do not experience any serious side effects.

Study Details

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.

Key Dates

First listed
Aug 8, 2006
Start date
May 31, 2006
Status verified
Dec 2016
Primary completion
Mar 31, 2009
Completion
Aug 31, 2012

Study Design

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

Arms

  • Experimental: Bevacizumab, Gemcitabine, Oxaliplatin
    * 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. * 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.

Primary Outcome Measure

Median Progression Free Survival [ Time Frame: 2 years ]

Locations (2)

FacilityCityStateZIPSite coordinators
Dana Farber Cancer InstituteBostonMassachusetts02215-
Massachusetts General Hospital Cancer CenterBostonMassachusetts02115-

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By research site
Dana Farber Cancer Institute· Boston, MAMassachusetts General Hospital Cancer Center· Boston, MA

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