drugset / Trial / NCT01588431
Bevacizumab/Ph 2 for Locally Advanced Head and Neck Cancer
NaSingle-groupOpen-labelTreatment
Summary
Locally advanced squamous cell carcinoma of the head and neck (SCCHN) is treated with various combinations of radiation and chemotherapy. This study aims to evaluate the rate of complete responses with induction therapy (primary endpoint) and progression-free survival, overall survival and objective response rates of docetaxel, cisplatin, cetuximab, and bevacizumab (TPE-A) followed by radiation therapy, cisplatin, cetuximab, and bevacizumab (XPE-A). Also, the investigators plan to investigate a panel of EGFR and angiogenesis biomarkers in pre-and post- treatment tumor biopsies. Finally, the investigators will evaluate the associated treatment toxicities and the quality of life.
Timeline
- Start
- 2011-12
- Primary completion
- 2022-10-04
- Completion
- 2022-10-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bevacizumab | Monoclonal antibody | 15 mg/kg | — |
| Subject | Cetuximab | Monoclonal antibody | 250 mg/m2 | — |
| Subject | Cisplatin | Other / unclassified | 30 mg/m2 | — |
| Subject | Docetaxel | Small molecule | 75 mg/m2 | — |