Ignite Creation Date:
2024-05-05 @ 5:01 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00361231
Status:
COMPLETED
Last Update Posted:
2017-02-07
First Post:
2006-08-04
Brief Title:
Gemcitabine Oxaliplatin in Combination With Bevacizumab in Biliary Tract and Gallbladder Cancer
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
Phase II Study of Gemcitabine Oxaliplatin in Combination With Bevacizumab Avastin in Unresectable or Metastatic Biliary Tract and Gallbladder Cancer
Status:
COMPLETED
Status Verified Date:
2016-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None