Ignite Creation Date:
2024-05-05 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00142480
Status:
COMPLETED
Last Update Posted:
2018-04-25
First Post:
2005-08-31
Brief Title:
Capecitabine Oxaliplatin Bevacizumab and Radiation Therapy in Patients With Biliary Tract and Gallbladder Cancer
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
Phase II Study of Capecitabine Oxaliplatin Bevacizumab and Radiation Therapy in Biliary Tract and Gallbladder Cancer
Status:
COMPLETED
Status Verified Date:
2018-04
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 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
Detailed Description:
There are two phases of study treatment The first phase is for all patients and will last about 6 weeks During this phase oxaliplatin will be given intravenously once a week during weeks 1 2 4 and 5 on days 1 8 22 and 29 bevacizumab will be given intravenously once every 2 weeks during weeks 1 3 and 5 on days 1 15 and 29 capecitabine will be administered orally for 14 consecutive days days 1-14 then a week of no capecitabine followed by another 14 days of capecitabine days 22-35
Radiation therapy will be given once daily for 5 days Monday-Friday per week for a total of 28 treatments
During this first phase of the study the following tests will be performed weekly physical exam vital signs medical history blood tests and urine tests
After the first phase is finished patients will wait 4 weeks then have a CT scan MRCP blood tests and a physical exam to evaluate the status of the disease
Phase two of the study is broken up into two groups 1 patients who had tumors removed prior to entering study and 2 patients who entered the study with advanced disease
If the patients had tumors removed prior to entering the study they will be treated again with all 3 study drugs but no radiation over a 6-week period as they did earlier in the study This 6-week regimen will be repeated twice for a total of 12 weeks of treatment
Patients with advanced disease that could not be removed by surgery when they first entered the study but the evaluation tests after the first phase show the tumor has responded reduced in size and can now be resected will have surgery to remove the tumors
Following surgical recovery 8-10 weeks they will be treated again with all 3 of the study drugs but no radiation over a 6-week period as they did earlier in the study This 6-week regimen will be repeated twice for a total of 12 weeks of study treatment
If the evaluation tests show that the patients cancer has remained stable not gotten worse or better they will be treated again with all three study drugs but no radiation over a 6-week period as they did earlier in the study This 6-week regimen will be repeated twice for a total of 12 weeks of study treatment
During the additional 12 weeks of study treatment a physical exam vital signs medical history blood testing and urine testing will be performed once every 3 weeks
At the end of study treatment the following evaluations will be performed physical exam vital signs blood work CT scan of the chest and abdomen MRCP and tumor measurements by CT scans These evaluations will be repeated every 3 months thereafter
Patients will be removed from the study if their disease worsens or there are unacceptable side effects
Radiation therapy will be given once daily for 5 days Monday-Friday per week for a total of 28 treatments
During this first phase of the study the following tests will be performed weekly physical exam vital signs medical history blood tests and urine tests
After the first phase is finished patients will wait 4 weeks then have a CT scan MRCP blood tests and a physical exam to evaluate the status of the disease
Phase two of the study is broken up into two groups 1 patients who had tumors removed prior to entering study and 2 patients who entered the study with advanced disease
If the patients had tumors removed prior to entering the study they will be treated again with all 3 study drugs but no radiation over a 6-week period as they did earlier in the study This 6-week regimen will be repeated twice for a total of 12 weeks of treatment
Patients with advanced disease that could not be removed by surgery when they first entered the study but the evaluation tests after the first phase show the tumor has responded reduced in size and can now be resected will have surgery to remove the tumors
Following surgical recovery 8-10 weeks they will be treated again with all 3 of the study drugs but no radiation over a 6-week period as they did earlier in the study This 6-week regimen will be repeated twice for a total of 12 weeks of study treatment
If the evaluation tests show that the patients cancer has remained stable not gotten worse or better they will be treated again with all three study drugs but no radiation over a 6-week period as they did earlier in the study This 6-week regimen will be repeated twice for a total of 12 weeks of study treatment
During the additional 12 weeks of study treatment a physical exam vital signs medical history blood testing and urine testing will be performed once every 3 weeks
At the end of study treatment the following evaluations will be performed physical exam vital signs blood work CT scan of the chest and abdomen MRCP and tumor measurements by CT scans These evaluations will be repeated every 3 months thereafter
Patients will be removed from the study if their disease worsens or there are unacceptable 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