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Bevacizumab or Cetuximab Combined With Gemcitabine, Capecitabine, and Radiation Therapy in Treating Patients With Pancreatic Cancer That Has Been Completely Removed By Surgery

Study:

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

Rationale:

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.

Purpose:

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.

Study Status: Active, not recruiting

Recruiting:
n/a

Condition Intervention Phase
Pancreatic Cancer Biological: bevacizumab
Biological: cetuximab
Drug: capecitabine
Drug: gemcitabine hydrochloride
Radiation: radiation therapy
Phase 2

Verified by National Cancer Institute (NCI) October, 2008

Sponsored by: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov identifier: NCT00305877

Study Type: Interventional

Study Design: Allocation: Randomized, Primary Purpose: Treatment

Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio 44195
United States

Community Oncology Group at Cleveland Clinic Cancer Center
Independence, Ohio 44131
United States

Cleveland Clinic - Wooster
Wooster, Ohio 44691
United States

Jordan D. Berlin, MD., Study Chair
Arthur William Blackstock, MD., Study Chair
Andrew M. Lowy, MD., Study Chair
Robert McWilliams, MD., Study Chair

This information is abridged to display results relevant only to Cleveland Clinic. To see complete record visit ClinicalTrials.gov
  Information obtained from ClinicalTrials.gov on
Link to the current ClinicalTrials.gov record.

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