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Alternate Title
Basic Trial Information
Trial Description
     Purpose
     Eligibility
     Treatment/Intervention
Trial Contact Information
Related Information
Registry Information

Alternate Title

Phase II Randomized Study of Adjuvant Therapy Comprising Bevacizumab Versus Cetuximab in Combination With Gemcitabine Hydrochloride, Capecitabine, and Radiotherapy in Patients With Completely Resected Carcinoma of the Pancreas

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Biomarker/Laboratory analysis, Treatment	Closed	18 and over	NCI	ECOG-E2204 CALGB-ECOG-E2204, SWOG-ECOG-E2204, NCCTG-ECOG-E2204, E2204, NCT00305877

Special Category: NCI Web site featured trial, NCI - CMS pilot project trial

Trial Description

Purpose:

Monoclonal antibodies, such as bevacizumab and cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Cetuximab may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as gemcitabine and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving bevacizumab or cetuximab together with gemcitabine, capecitabine, and radiation therapy after surgery may kill any tumor cells that remain after surgery. It is not yet known whether bevacizumab is more effective than cetuximab when given together with gemcitabine, capecitabine, and radiation therapy in treating pancreatic cancer.

This randomized phase II trial is studying bevacizumab to see how well it works compared to cetuximab when given together with gemcitabine, capecitabine, and radiation therapy in treating patients with pancreatic cancer that has been completely removed by surgery.

Eligibility:

Eligibility criteria include the following:

• At least 18 years old
• Has undergone surgery to completely remove the tumor more than 4 weeks but no more than 8 weeks ago
• No metastatic cancer
• No previous chemotherapy or radiation therapy for this cancer
• For more information about the eligibility criteria for this trial, refer to the Health Professional version.

Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Treatment/Intervention:

Patients will be randomly assigned (have an equal chance of being placed) to one of two treatment groups.

Patients in group one will receive a 1- to 2-hour infusion of cetuximab once a week for approximately 6 months. They will also receive an infusion of gemcitabine once a week in weeks 1-3, 13-15, 17-19, and 21-23. Patients will receive capecitabine by mouth twice a day 5 days a week in weeks 5-10 and at the same time, they will also undergo radiation therapy once a day 5 days a week for approximately 5½ weeks.

Patients in group two will receive a 60- to 90-minute infusion of bevacizumab once every 2 weeks for approximately 6 months. They will also receive an infusion of gemcitabine once a week in weeks 1-3, 13-15, 17-19, and 21-23. Patients will receive capecitabine by mouth twice a day 5 days a week in weeks 5-10 and at the same time, they will also undergo radiation therapy once a day 5 days a week for approximately 5½ weeks.

Tumor samples will be collected from patients in both groups and are examined in the laboratory.

After finishing treatment, patients will be evaluated periodically for up to 3 years.

Important:

For more details about this trial, refer to the Health Professional version of the trial summary.

If you are interested in participating in a clinical trial, contact your doctor for a referral or call a trial contact person listed below. You may see the same contact person listed at more than one site, however, if you call the number listed you can ask to speak to the study coordinator or person involved with the specific trial you are interested in. If you have questions about cancer or clinical trials, call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). General information about clinical trials, including risks, benefits, and costs, can be found on NCI's Web site.

Trial Contact Information

Trial Lead Organizations

Eastern Cooperative Oncology Group

Jordan Berlin, MD, Protocol chair		Ph: 615-322-4967; 800-811-8480 Email: jordan.berlin@vanderbilt.edu

Cancer and Leukemia Group B

Arthur William Blackstock, MD, Protocol chair		Ph: 336-713-6501; 800-446-2255

Southwest Oncology Group

Andrew Lowy, MD, Protocol chair		Ph: 858-822-5354

North Central Cancer Treatment Group

Robert McWilliams, MD, Protocol chair		Ph: 507-284-2511

Related Information

Featured trial article

Registry Information
Official Title		An Intergroup Randomized Phase II Study of Bevacizumab (NSC 704865) or Cetuximab (NSC 714692) in Combination with Gemcitabine and in Combination with Chemoradiation (Capecitabine and Radiation) in Patients with Completely-Resected Pancreatic Carcinoma
Trial Start Date		2006-02-17
Trial Completion Date		2008-08-31 (estimated)
Registered in ClinicalTrials.gov		NCT00305877
Date Submitted to PDQ		2005-11-28
Information Last Verified		2008-10-22
NCI Grant/Contract Number		CA21115