Status:
COMPLETED
Bevacizumab or Cetuximab And Gemcitabine Hydrochloride, Capecitabine, and Radiation Therapy in Treating Patients With Pacreatic Cancer That Has Been Completely Removed By Surgery
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Stage IA Pancreatic Cancer
Stage IB Pancreatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 wit...
Detailed Description
PRIMARY OBJECTIVES: I. To describe the toxicity profile of cetuximab and bevacizumab when combined with gemcitabine, before and after capecitabine plus radiation and during capecitabine plus radiatio...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- 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:
- Arterial thrombembolic events
- Unstable angina
- Myocardial infarction
Exclusion
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
137 Patients enrolled
Trial Details
Trial ID
NCT00305877
Start Date
February 1 2006
End Date
February 1 2012
Last Update
May 21 2014
Active Locations (1)
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1
Eastern Cooperative Oncology Group
Boston, Massachusetts, United States, 02215