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

Completed · Phase 2

Conditions studied: Stage IA Pancreatic Cancer, Stage IB Pancreatic Cancer, Stage IIA Pancreatic Cancer, Stage IIB Pancreatic Cancer

In brief

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. 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.

Key facts

Study ID: NCT00305877
Run by: National Cancer Institute (NCI)
People needed: 137
Starts: 2006-02-01
Expected to finish: 2012-02-01
Last updated by the study team: 2014-05-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Patients must have histologically or cytologically confirmed evidence of pancreatic carcinoma
Patients must have had all gross disease resected (R0 or R1 resection)
Patients undergoing an R2 resection are not eligible
Patients must have had no prior chemotherapy or radiation therapy for pancreatic cancer and must have had no prior EGFR/VEGF inhibition
Patient must have ECOG performance status of 0-2
Leukocytes >= 3,000/μL
ANC >= 1,500/μL
Platelets >= 100,000/μL
Total bilirubin Within normal institutional limits
AST (SGOT)/ALT(SGPT) =< 2.5 X institutional upper limit of normal
Creatinine clearance >= 60 mL/min for patients with creatinine levels above institutional normal
Patients must be > 4 weeks and =< 8 weeks post-surgery at time of study registration (may be up to 10 weeks post-surgery prior to start of study therapy)
Women of childbearing potential and sexually active males are strongly advised to use an accepted and effective method of contraception prior to study entry
Women must not be pregnant or breast-feeding; all agents used in this study as well as radiation therapy to the abdomen have the potential for teratogenic or abortifacient effects; all females of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy
Patients must not be receiving any other investigational agents
Patients with known metastases are not eligible
Patients with a history of allergic reactions attributed to compounds of similar chemical or biologic composition to cetuximab, bevacizumab or other agents used in the study are not eligible
Patients with wounds that have not fully healed are not eligible
Patients must not have cardiac arrhythmia
Patients must have no known HIV infection
Patients must not have any of the following: acinar cell carcinoma, neuroendocrine carcinoma, cystadenocarcinoma, carcinosarcoma
Patients with psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude them from meeting the study requirements are not eligible
Patients requiring full dose anticoagulation are not eligible
Patients with a history of transient ischemic attack (TIA) or cerebrovascular accident (CVA) are not eligible
Patients with a history of the following within twelve months of study entry are not eligible:

Where it is running

Eastern Cooperative Oncology Group — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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