Clinical trial NCT00338039
Conditions: Pancreatic Cancer
Keywords: Pancreatic Cancer Cetuximab C225 Erbitux Gemcitabine Oxaliplatin Eloxatin Capecitabine Xeloda
Sponsor: M.D. Anderson Cancer Center
Start date: 2005-09-01; Completion date: 2011-06-01
Enrollment: 69 participants; Allocation: NA; Intervention model: SINGLE_GROUP

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.

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 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 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 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. Anderson.

Arms: arm 1: Systemic chemotherapy followed by chemoradiation in locally advanced pancreatic cancer. Cetuximab 500 mg/m\^2 intravenous (IV)/week +/-1 day continued throughout induction chemotherapy, chemoradiation and maintenance chemotherapy. Induction Therapy Gemcitabine 1 gm/m\^2 over 100 minutes every 2 weeks +/-1 day for 4 doses; Induction Chemotherapy Oxaliplatin 100 mg/m\^2 over 120 minutes every 2 weeks +/-1 day for 4 doses. Capecitabine Chemoradiation (to start 2-3 weeks post completion of oxaliplatin and gemcitabine): 825 mg/m\^2 by mouth (PO) twice daily Monday-Friday throughout radiation. Conformal radiation therapy to gross disease, total dose = 50.4 Gy delivered in 28 fractions.
Interventions: intervention 1: Cetuximab intervention 2: Gemcitabine intervention 3: Oxaliplatin intervention 4: Capecitabine intervention 5: Radiotherapy
Intervention descriptions: intervention 1: 500 mg/m\^2 IV/week +/-1 day continued throughout induction chemotherapy, chemoradiation and maintenance chemotherapy. intervention 2: Induction Therapy: 1 gm/m\^2 over 100 minutes every 2 weeks +/-1 day for 4 doses.

Chemotherapy Maintenance: 1 gm/m\^2/week over 100 minutes weekly for 3 weeks then 1 week off. intervention 3: Induction Chemotherapy: 100 mg/m\^2 over 120 minutes every 2 weeks +/-1 day for 4 doses. intervention 4: Chemoradiation (to start 2-3 weeks post completion of oxaliplatin and gemcitabine): 825 mg/m\^2 by mouth (PO) twice daily Monday-Friday throughout radiation. intervention 5: Conformal radiation therapy to gross disease, total dose = 50.4 Gy delivered in 28 fractions.

Protocol documents: