Ignite Creation Date:
2024-05-05 @ 4:53 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00338039
Status:
COMPLETED
Last Update Posted:
2013-03-22
First Post:
2006-01-27
Brief Title:
Induction Cetuximab IM-C225 Gemcitabine and Oxaliplatin in Pancreatic Cancer Patients
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Induction Cetuximab IM-C225 Gemcitabine and Oxaliplatin Followed by Radiotherapy With Concurrent Capecitabine and Cetuximab Followed by Maintenance Cetuximab and Gemcitabine for Patients With Locally Advanced Pancreatic Cancer
Status:
COMPLETED
Status Verified Date:
2013-02
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 primary objective is to evaluate the efficacy of a combination of cetuximab with systemic chemotherapy followed by chemoradiation in locally advanced pancreatic cancer The primary endpoint is actuarial one-year survival
The secondary objectives are
To evaluate the local tumor response in patients treated with the above regimen
To characterize the safety of the above regimen
The secondary objectives are
To evaluate the local tumor response in patients treated with the above regimen
To characterize the safety of the above regimen
Detailed Description:
Cetuximab is a drug that blocks epidermal growth factor receptor EGFR EGFR may be involved in certain types of cancer When EGFR is stimulated a series of chemical reactions starts that results in a tumor being told to grow Cetuximab tries to stop these reactions by blocking EGFR This may stop tumors from growing Cetuximab has been shown to increase the effect of chemotherapy and of radiation therapy both of which will also be given in this study
Before you can start treatment on this study you will have what are called screening tests These tests will help the doctor decide if you are eligible to take part in the study You will have a complete medical history and physical exam Blood about 2 tablespoons and urine will be collected for routine tests 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 urine pregnancy test
If you are found to be eligible to take part in this study you will first receive cetuximab every 2 weeks for 8 weeks 4 doses Cetuximab will be given every 2 weeks throughout the duration of the study Cetuximab will be continued during the radiation and capecitabine combination during the retesting stage and then during the chemotherapy that is given after radiation therapy Cetuximab infusions will be given over approximately 2 hours Gemcitabine and oxaliplatin chemotherapy will be given once every 2 weeks 4 doses for 8 weeks Both drugs are given through a central line and over about 2 hours Cetuximab will be given first followed by gemcitabine and then followed by oxaliplatin A CT scan and chest X-ray will be done 2 weeks after the last dose at Week 10
As long as the tumor has not grown or spread you will then receive cetuximab capecitabine and radiation therapy together The Capecitabine will be given by mouth twice a day every day of radiation therapy 5 and 12 weeks Radiation therapy will be given once a day for 5 days in a row It will be given for 5 and 12 weeks or 28 treatments The radiation will be given from 4 directions and focused on the tumor while you are lying on your back You will continue to receive cetuximab by vein once every 2 weeks during capecitabine and radiation therapy
After radiotherapy you will continue to take cetuximab by vein every 2 weeks The effect of treatment will be evaluated 5-6 weeks after the completion of radiation therapy and capecitabine A chest x-ray and CT scans will be performed and about 2 tablespoons of blood will be drawn for routine testing As long as the tumor has not grown or spread and the side effects are not too severe you may continue to receive Cetuximab by vein once every 2 weeks You will also receive Gemcitabine by vein in the same dose as before for 3 out of every 4 weeks as long as the tumor does not grow and the side effects are not too severe CT scans and chest x-rays will then be done every 2 months to evaluate the status of the tumor
During the study you will have physical exams including weekly blood tests about 2 tablespoons each The possible development of side effects will be closely monitored and could require extra blood andor urine samples
You will be taken off study if your disease gets worse or intolerable side effects occur You may have surgery if at any time during therapy the tumor can be removed surgically A separate consent form will be used for that situation
This is an investigational study Capecitabine oxaliplatin and cetuximab are approved by the FDA for colon cancer but have not been approved by the FDA for pancreatic cancer Up to 69 patients will take part in this multicenter study Up to 60 will be enrolled at M D Anderson
Before you can start treatment on this study you will have what are called screening tests These tests will help the doctor decide if you are eligible to take part in the study You will have a complete medical history and physical exam Blood about 2 tablespoons and urine will be collected for routine tests 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 urine pregnancy test
If you are found to be eligible to take part in this study you will first receive cetuximab every 2 weeks for 8 weeks 4 doses Cetuximab will be given every 2 weeks throughout the duration of the study Cetuximab will be continued during the radiation and capecitabine combination during the retesting stage and then during the chemotherapy that is given after radiation therapy Cetuximab infusions will be given over approximately 2 hours Gemcitabine and oxaliplatin chemotherapy will be given once every 2 weeks 4 doses for 8 weeks Both drugs are given through a central line and over about 2 hours Cetuximab will be given first followed by gemcitabine and then followed by oxaliplatin A CT scan and chest X-ray will be done 2 weeks after the last dose at Week 10
As long as the tumor has not grown or spread you will then receive cetuximab capecitabine and radiation therapy together The Capecitabine will be given by mouth twice a day every day of radiation therapy 5 and 12 weeks Radiation therapy will be given once a day for 5 days in a row It will be given for 5 and 12 weeks or 28 treatments The radiation will be given from 4 directions and focused on the tumor while you are lying on your back You will continue to receive cetuximab by vein once every 2 weeks during capecitabine and radiation therapy
After radiotherapy you will continue to take cetuximab by vein every 2 weeks The effect of treatment will be evaluated 5-6 weeks after the completion of radiation therapy and capecitabine A chest x-ray and CT scans will be performed and about 2 tablespoons of blood will be drawn for routine testing As long as the tumor has not grown or spread and the side effects are not too severe you may continue to receive Cetuximab by vein once every 2 weeks You will also receive Gemcitabine by vein in the same dose as before for 3 out of every 4 weeks as long as the tumor does not grow and the side effects are not too severe CT scans and chest x-rays will then be done every 2 months to evaluate the status of the tumor
During the study you will have physical exams including weekly blood tests about 2 tablespoons each The possible development of side effects will be closely monitored and could require extra blood andor urine samples
You will be taken off study if your disease gets worse or intolerable side effects occur You may have surgery if at any time during therapy the tumor can be removed surgically A separate consent form will be used for that situation
This is an investigational study Capecitabine oxaliplatin and cetuximab are approved by the FDA for colon cancer but have not been approved by the FDA for pancreatic cancer Up to 69 patients will take part in this multicenter study Up to 60 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