Capecitabine, Oxaliplatin, Bevacizumab and Radiation Therapy in Patients With Biliary Tract and Gallbladder Cancer

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT00142480
Phase
PHASE2
Status
Completed

Conditions

  • Biliary Tract Cancer
  • Gallbladder Adenocarcinoma

Eligibility Criteria

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

Interventions

  • Capecitabine — DRUG
    Given orally for 14 consecutive days (days 1-14) followed by a week of no capecitabine then another week of 14 consecutive days (days 21-28).
  • Oxaliplatin — DRUG
    Given intravenously once weekly during weeks 1, 2, 4 and 5 on days 1, 8, 22 and 29
  • Bevacizumab — DRUG
    Given intravenously every two weeks during weeks 1, 3 and 5 on days 1, 15 and 29.
  • Radiation therapy — PROCEDURE
    Once daily for 5 days (Monday through Friday) for a total of 28 treatments.

Study Details

The main purpose of this study is to test the safety and effectiveness of oxaliplatin, bevacizumab, and capecitabine given in combination with radiation therapy to see what effects (good or bad) they have on patients with biliary tract and gallbladder cancer.

Key Dates

First listed
Sep 2, 2005
Start date
Dec 31, 2004
Status verified
Apr 2018
Primary completion
Jul 31, 2007
Completion
Apr 30, 2011

Study Design

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

Arms

  • Experimental: Capecitabine, Oxaliplatin, Bevacizumab
    There are two phases of study treatment. Phase I includes all patients and will last 6 weeks. During this phase, oxaliplatin will be given intravenously (IV) on days 1, 8, 22, and 29; bevacizumab will be given IV on days 1, 15, and 29; capecitabine will be administered orally on days 1-14 and 22-35. Radiation therapy will be given once daily for 5 days (Monday-Friday) per week for a total of 28 treatments. Phase II has two groups: 1) patients who had tumors removed prior to entering study and 2) patients who entered the study with advanced disease. Patients who had their tumors removed prior to entering the study will be treated with the above 6-week regimen twice for a total of 12 weeks of treatment. Patients who were unresectable prior to entering the study but then were deemed resectable after treatment on trial will undergo resection. Following surgical recovery (8-10 weeks) they will be treated again with the above 6-week regimen twice for a total of 12 weeks of treatment.

Primary Outcome Measure

To determine the progression free survival rate at one year for locally advanced, or resected with positive margins, biliary tract and gallbladder cancer patients [ Time Frame: 3 years ]

Locations (3)

FacilityCityStateZIPSite coordinators
Beth Israel Deaconess Medical CenterBostonMassachusetts02118-
Dana-Farber Cancer InstituteBostonMassachusetts02115-
Massachusetts General HospitalBostonMassachusetts02114-

Find similar trials in Boston, MA

By research site
Beth Israel Deaconess Medical Center· Boston, MADana-Farber Cancer Institute· Boston, MAMassachusetts General Hospital· Boston, MA

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