Phase 2
Completed N=137
Bevacizumab or Cetuximab And Gemcitabine Hydrochloride, Capecitabine, and Radiation Therapy in Treating Patients With Pacreatic Cancer That Has Been Completely Removed By Surgery
Source: ClinicalTrials.gov NCT00305877 ↗Enrolled (actual)
137
Serious AEs
80.8%
Results posted
Nov 2013
Primary outcomePrimary: Proportion of Patients With Specific Protocol Defined Adverse Event at Conclusion of All Therapy — 0.30; 0.25 Proportion of patients
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 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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Patients With Specific Protocol Defined Adverse Event at Conclusion of All Therapy |
0.30; 0.25 | — |
| SECONDARY Two-year Overall Survival Rate |
0.38; 0.37 | — |
| SECONDARY Two-year Disease-free Survival (DFS) |
0.17; 0.23 | — |
Eligibility Criteria
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) = = 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
Data sourced from ClinicalTrials.gov (NCT00305877). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.