Ignite Creation Date:
2024-05-05 @ 4:52 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00336648
Status:
COMPLETED
Last Update Posted:
2012-07-30
First Post:
2006-06-13
Brief Title:
Preop Chemoradiation Resectable Pancreas
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
A Phase II Pilot Study of Preoperative Gemcitabine and Bevacizumab-Based Chemoradiation for Patients With Resectable Adenocarcinoma of the Pancreas
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:
Primary Objective
1 To assess resectability rate in patients undergoing gemcitabine plus Avastin-based chemoradiation followed by pancreaticoduodenectomy for adenocarcinoma of the pancreas
Secondary Objectives
1 To assess disease free survival and overall survival
2 To assess margin resection rate R0 vs R1 in these patients
3 To assess patterns of failure
1 To assess resectability rate in patients undergoing gemcitabine plus Avastin-based chemoradiation followed by pancreaticoduodenectomy for adenocarcinoma of the pancreas
Secondary Objectives
1 To assess disease free survival and overall survival
2 To assess margin resection rate R0 vs R1 in these patients
3 To assess patterns of failure
Detailed Description:
Gemcitabine is designed to disrupt the growth of the cancer cells which causes the cancer cells to start to die
Avastin is designed to prevent or slow down the growth of tumors by its damaging effects on blood vessel growth in tumors
Before treatment starts you will have a complete physical exam Blood about 2 tablespoons will be drawn for tests and a urine test will be performed Chest x-rays and computed tomography CT scans of the abdomen will be done Women who are able to have children must have a negative blood 1-2 tablespoons pregnancy test
If you are found to be eligible to take part in this study you will receive gemcitabine once a week Avastin once every 2 weeks and radiation 5 times a week Gemcitabine and Avastin will be given on Saturdays and the radiation will be given Monday through Friday of each week You will receive this treatment as an outpatient for 6 weeks
You will receive gemcitabine through a needle in a vein on Days 1 8 15 22 29 and 36 - 2 days You will receive Avastin through a needle in a vein every 2 weeks on Days 1 15 and 29 - 2 days On the days you receive both drugs you will receive Avastin over 30-90 minutes and gemcitabine over 40 minutes
The first dose of Avastin will be given over about 90 minutes If you do not have a reaction such as feverchills the next dose will be given over about 60 minutes and if again no reaction occurs each dose after that will be given over about 30 minutes If you experience a reaction to the Avastin infusion you may be given acetaminophen such as Tylenol by mouth andor diphenhydramine Benadryl by vein over 30 minutes before each dose to decrease the risk of further reactions
Radiation will be given Monday through Friday for 5 12 weeks Each day of treatment you will lie on a treatment table The radiation therapist will help position your body so that the radiation goes to the right place A machine will deliver the radiation It will take about 15-20 minutes to receive the radiation treatment each day
If any days of radiation are missed these days will be made up at the end of your treatment at the end of 28 days so that you receive the full amount of radiation
During the study you will have physical exams weekly while you are receiving chemoradiation every other week while you are receiving chemotherapy after surgery and every 4 months during the follow-up period You will have blood drawn 1-2 tablespoons each time for routine tests on a weekly basis while you are receiving chemoradiation every other week while you are taking Avastin after surgery for 3 months and every 4 months during the follow-up period The possible development of side effects will be closely monitored and could require extra blood andor urine samples You may also have physical exams blood and urine tests x-rays and scans after completing the chemoradiation part of the study depending upon what is medically needed for evaluation of ongoing therapy
The overall effect of treatment will be evaluated at least 8 weeks - 2 days after the completion of chemoradiation A chest x-ray and CT scans of the chest abdomen and pelvis will then be performed and blood about 2 tablespoons will be drawn for routine tests Some participants will have surgery to remove part of the pancreas if needed The reason to wait at least 8 weeks is to allow a safe period of time to pass after the last dose of Avastin to prevent bleeding during surgery It may also help decrease the risk of postoperative complications including bleeding and poor wound healing
This research study allows participants to receive up to 3 infusions of Avastin during the chemoradiation part of the study If the treatment is shown to benefit you your doctor may continue to give additional infusions of Avastin every 2 weeks - 2 days for 3 months after surgery After the Avastin treatment you will have a chest x-ray abdominal CT scan and blood about 2 tablespoons will be drawn for routine tests every 4 months after surgery for 2 years to check the status of the tumor
This is an investigational study The study drugs are commercially available and FDA approved but their use together with radiation is experimental Avastin is FDA approved for colon and lung cancers but has not been evaluated by the FDA for pancreatic cancer Gemcitabine is FDA approved for pancreatic cancer Avastin will be provided free of charge during the study however the cost of the infusion of the drug will be the responsibility of you andor your insurance company The costs of gemcitabine and radiation are considered standard of care and will be the responsibility of you andor your insurance company Up to 31 patients will take part in this study All will be enrolled at M D Anderson
Avastin is designed to prevent or slow down the growth of tumors by its damaging effects on blood vessel growth in tumors
Before treatment starts you will have a complete physical exam Blood about 2 tablespoons will be drawn for tests and a urine test will be performed Chest x-rays and computed tomography CT scans of the abdomen will be done Women who are able to have children must have a negative blood 1-2 tablespoons pregnancy test
If you are found to be eligible to take part in this study you will receive gemcitabine once a week Avastin once every 2 weeks and radiation 5 times a week Gemcitabine and Avastin will be given on Saturdays and the radiation will be given Monday through Friday of each week You will receive this treatment as an outpatient for 6 weeks
You will receive gemcitabine through a needle in a vein on Days 1 8 15 22 29 and 36 - 2 days You will receive Avastin through a needle in a vein every 2 weeks on Days 1 15 and 29 - 2 days On the days you receive both drugs you will receive Avastin over 30-90 minutes and gemcitabine over 40 minutes
The first dose of Avastin will be given over about 90 minutes If you do not have a reaction such as feverchills the next dose will be given over about 60 minutes and if again no reaction occurs each dose after that will be given over about 30 minutes If you experience a reaction to the Avastin infusion you may be given acetaminophen such as Tylenol by mouth andor diphenhydramine Benadryl by vein over 30 minutes before each dose to decrease the risk of further reactions
Radiation will be given Monday through Friday for 5 12 weeks Each day of treatment you will lie on a treatment table The radiation therapist will help position your body so that the radiation goes to the right place A machine will deliver the radiation It will take about 15-20 minutes to receive the radiation treatment each day
If any days of radiation are missed these days will be made up at the end of your treatment at the end of 28 days so that you receive the full amount of radiation
During the study you will have physical exams weekly while you are receiving chemoradiation every other week while you are receiving chemotherapy after surgery and every 4 months during the follow-up period You will have blood drawn 1-2 tablespoons each time for routine tests on a weekly basis while you are receiving chemoradiation every other week while you are taking Avastin after surgery for 3 months and every 4 months during the follow-up period The possible development of side effects will be closely monitored and could require extra blood andor urine samples You may also have physical exams blood and urine tests x-rays and scans after completing the chemoradiation part of the study depending upon what is medically needed for evaluation of ongoing therapy
The overall effect of treatment will be evaluated at least 8 weeks - 2 days after the completion of chemoradiation A chest x-ray and CT scans of the chest abdomen and pelvis will then be performed and blood about 2 tablespoons will be drawn for routine tests Some participants will have surgery to remove part of the pancreas if needed The reason to wait at least 8 weeks is to allow a safe period of time to pass after the last dose of Avastin to prevent bleeding during surgery It may also help decrease the risk of postoperative complications including bleeding and poor wound healing
This research study allows participants to receive up to 3 infusions of Avastin during the chemoradiation part of the study If the treatment is shown to benefit you your doctor may continue to give additional infusions of Avastin every 2 weeks - 2 days for 3 months after surgery After the Avastin treatment you will have a chest x-ray abdominal CT scan and blood about 2 tablespoons will be drawn for routine tests every 4 months after surgery for 2 years to check the status of the tumor
This is an investigational study The study drugs are commercially available and FDA approved but their use together with radiation is experimental Avastin is FDA approved for colon and lung cancers but has not been evaluated by the FDA for pancreatic cancer Gemcitabine is FDA approved for pancreatic cancer Avastin will be provided free of charge during the study however the cost of the infusion of the drug will be the responsibility of you andor your insurance company The costs of gemcitabine and radiation are considered standard of care and will be the responsibility of you andor your insurance company Up to 31 patients will take part in this study All will be enrolled at 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