drugset / Trial / NCT01588431

Bevacizumab/Ph 2 for Locally Advanced Head and Neck Cancer

NCT01588431 ↗

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

EvaluationDrugModalityDoseRoute
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 —