drugset / Trial / NCT00703976
Radiation, Cetuximab and Pemetrexed With or Without Bevacizumab in Locally Advanced Head and Neck Cancer
Phase 2
Completed
80 enrolled
University of Pittsburgh
Eli Lilly and Company · collabGenentech, Inc. · collab
RandomizedSingle-groupOpen-labelDiagnostic
Summary
The purpose of this study is to compare the effects (good and bad) of chemoradiotherapy with or without Bevacizumab (Avastin). Chemoradiotherapy is the combination of chemotherapy (the drugs pemetrexed and cetuximab) and radiation. Pemetrexed is not approved by the Food and Drug Administration (FDA) for head and neck cancer when used in combination with radiation therapy. Cetuximab is also approved by the FDA for head and neck cancers in patients who have failed other chemotherapy treatments. Bevacizumab is approved by the Food and Drug Administration (FDA) for colorectal cancer and non-small cell lung cancer in combination of chemotherapy. In this study, the use of bevacizumab is investigational.
Timeline
- Start
- 2008-10
- Primary completion
- 2014-09
- Completion
- 2014-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bevacizumab | Monoclonal antibody | 15 mg/kg | — |
| Background | Cetuximab | Monoclonal antibody | 250 mg/m2 | — |
| Background | Pemetrexed | Small molecule | 500 mg/m2 | — |