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Monoclonal Antibodies
Gemcitabine, Oxaliplatin in Combination With Bevacizumab in Biliary Tract and Gallbladder Cancer
Boston, MA
Phase 2
Waitlist Available
Led By Andrew X. Zhu, MD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Approved for 10 Other Conditions
All Individual Drugs Already Approved
No Placebo-Only Group
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.
See full description
Eligible Conditions
- Gallbladder Cancer
- Biliary Tract Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Median Progression Free Survival
Secondary study objectives
Overall Response Rate
Awards & Highlights
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Bevacizumab, Gemcitabine, OxaliplatinExperimental Treatment3 Interventions
* 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bevacizumab
FDA approved
Gemcitabine
FDA approved
Oxaliplatin
FDA approved
Find a Location
Closest Location:Massachusetts General Hospital Cancer Center· Boston, MA· 644 miles
Who is running the clinical trial?
SanofiIndustry Sponsor
2,245 Previous Clinical Trials
4,084,829 Total Patients Enrolled
Brigham and Women's HospitalOTHER
1,693 Previous Clinical Trials
14,788,144 Total Patients Enrolled
Dana-Farber Cancer InstituteOTHER
1,127 Previous Clinical Trials
381,846 Total Patients Enrolled
Beth Israel Deaconess Medical CenterOTHER
871 Previous Clinical Trials
12,931,427 Total Patients Enrolled
Massachusetts General HospitalLead Sponsor
3,061 Previous Clinical Trials
13,425,735 Total Patients Enrolled
Genentech, Inc.Industry Sponsor
1,577 Previous Clinical Trials
570,944 Total Patients Enrolled
Andrew X. Zhu, MDPrincipal InvestigatorMassachusetts General Hospital
3 Previous Clinical Trials
70 Total Patients Enrolled