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
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 1/2 weeks). Radiation therapy will be given once a day for
5 days in a row. It will be given for 5 and 1/2 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
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 and/or 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.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall Survival Rate
1-year, 2-year, and 4-year actuarial overall survival (OS) rates defined as number of participants out of total participants alive at 1, 2 or 4 years post baseline treatment.
1 to 4 years
Christopher H. Crane, MD
M.D. Anderson Cancer Center
United States: Institutional Review Board
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