Clinical trial · Interventional
Bevacizumab or Cetuximab And Gemcitabine Hydrochloride, Capecitabine, and Radiation Therapy in Treating Patients With Pacreatic Cancer That Has Been Completely Removed By Surgery
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Stage IA Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_BROADER | 0.78 |
| Stage IB Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIA Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIB Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bevacizumab | Biological | Bevacizumab | ALIAS |
| capecitabine | Drug | Capecitabine | ALIAS |
| cetuximab | Biological | Cetuximab | ALIAS |
| gemcitabine hydrochloride | Drug | Gemcitabine | ALIAS |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I (cetuximab, gemcitabine, capecitabine, radiation)
- description
- Patients receive cetuximab IV over 60-120 minutes on day 1, once weekly, in weeks 1-24; gemcitabine hydrochloride IV over 30 minutes on day 1, once weekly, in weeks 1-3, 13-15, 17-19, and 21-23; oral capecitabine twice daily on days 1-5, 5 days a week, in weeks 5-10. Patients also undergo radiotherapy once daily, 5 days a week, beginning in week 5 and continuing for approximately 5½ weeks (25 fractions).
- interventionNames
- Biological: cetuximab
- Drug: gemcitabine hydrochloride
- Drug: capecitabine
- Radiation: radiation therapy
- Other: laboratory biomarker analysis
- type
- EXPERIMENTAL
- label
- Arm II (bevacizumab, gemcitabine, capecitabine, radiation)
- description
- Patients receive bevacizumab IV over 60-90 minutes on day 1 in weeks 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, and 23. Patients also receive gemcitabine hydrochloride and capecitabine and undergo radiotherapy as in arm I.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available