Ignite Creation Date:
2024-05-05 @ 11:43 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00113230
Status:
COMPLETED
Last Update Posted:
2012-08-07
First Post:
2005-06-06
Brief Title:
Neoadjuvant Chemoradiation With RHUMAB VEGF Avastin for Rectal Cancer
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Phase II Trial Of Neoadjuvant Concurrent Capecitabine RHUMAB VEGF Avastin And Radiotherapy In Patients Presenting With Locally Advanced Rectal Cancer
Status:
COMPLETED
Status Verified Date:
2012-07
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:
Preoperative chemoradiation leads to increased pelvic control and overall survival but both distant and local disease control remain problematic in locally advanced rectal cancer patients Enhancing the effect of chemotherapy and radiotherapy can increase tumor response as well as distant disease control Patients who have complete response to therapy have increased sphincter preservation and can possibly have more limited surgery full thickness local excision When combined with standard chemotherapy bevacizumab RHUMAB VEGF Avastin has been shown to improve response and median survival in patients with metastatic colorectal cancer in a recent randomized trial has led to increased activity in preclinical studies with radiotherapy and has been found to be very well tolerated with chemoradiation in a phase I trial conducted at the MD Anderson Cancer Center MDACC in patients with locally advanced pancreatic cancer The hypothesis is that the addition of bevacizumab to standard chemoradiation will safely lead to increased tumor response in patients with locally advanced rectal cancer
Detailed Description:
Avastin RHUMAB VEGF Bevacizumab is a drug that has damaging effects on blood vessel growth in tumors
Before treatment starts you will have a complete physical exam About 2 tablespoons of blood will be drawn for routine tests and a urine test will be performed Chest x-rays and CT scans of the abdomen and pelvis will be done Women who are able to have children must have a negative blood pregnancy test
You will receive radiation therapy once a day for 5 days in a row Monday-Friday for 5 weeks and three days a total of 28 treatments You will take the chemotherapy drug capecitabine by mouth twice a day on each of the days that you receive radiation therapy These pills will not be taken on Saturday and Sunday You must not take cimetidine and must be off of coumadin for at least one week and sorivudine and brivudine for at least four weeks before starting capecitabine and while taking capecitabine
You will receive the drug Avastin by vein once every 2 weeks for six weeks a total of three doses The infusion will at first last 90 minutes If there are no allergic reactions fevers or chills it will be shortened to 60 minutes and then 30 minutes for later infusions
During the study you will have physical exams including weekly blood tests about 2 teaspoons The possible development of side effects will be closely monitored
All participants will have surgical removal of the rectal tumor 6-8 weeks after the completion of treatment as they would for the standard of care for their disease No patients will have surgery before 6 weeks
After participation in this study is over you will have follow-up evaluation as needed for standard of care
THIS IS AN INVESTIGATIONAL STUDY Capecitabine is approved by the FDA but Avastin has not yet been evaluated for approval
About 50 patients will take part in the study All will be enrolled at the M D Anderson
Before treatment starts you will have a complete physical exam About 2 tablespoons of blood will be drawn for routine tests and a urine test will be performed Chest x-rays and CT scans of the abdomen and pelvis will be done Women who are able to have children must have a negative blood pregnancy test
You will receive radiation therapy once a day for 5 days in a row Monday-Friday for 5 weeks and three days a total of 28 treatments You will take the chemotherapy drug capecitabine by mouth twice a day on each of the days that you receive radiation therapy These pills will not be taken on Saturday and Sunday You must not take cimetidine and must be off of coumadin for at least one week and sorivudine and brivudine for at least four weeks before starting capecitabine and while taking capecitabine
You will receive the drug Avastin by vein once every 2 weeks for six weeks a total of three doses The infusion will at first last 90 minutes If there are no allergic reactions fevers or chills it will be shortened to 60 minutes and then 30 minutes for later infusions
During the study you will have physical exams including weekly blood tests about 2 teaspoons The possible development of side effects will be closely monitored
All participants will have surgical removal of the rectal tumor 6-8 weeks after the completion of treatment as they would for the standard of care for their disease No patients will have surgery before 6 weeks
After participation in this study is over you will have follow-up evaluation as needed for standard of care
THIS IS AN INVESTIGATIONAL STUDY Capecitabine is approved by the FDA but Avastin has not yet been evaluated for approval
About 50 patients will take part in the study All will be enrolled at the M D Anderson
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