drugset / Trial / NCT00500760

Study of Addition of Panitumumab to Chemoradiation Therapy in Patients With Locally Advanced Head and Neck Cancer

NCT00500760 ↗

Phase 2 Completed 153 enrolled Amgen
RandomizedParallel-groupOpen-labelTreatment

Summary

The addition of chemotherapy to radiotherapy (chemoradiation) has improved outcomes for patients with locally advanced squamous cell carcinoma of the head and neck but additional improvements to treatment regimens are needed. The study is investigating if the addition of a targeted therapy (panitumumab) can improve the efficacy of chemoradiation without adding unmanageable toxicity.

Timeline

Start
2007-10-01
Primary completion
2011-03-29
Completion
2011-04-26

Outcome

Missed primary endpoint

registry Difference in Kaplan-Meier estimate -0.07 (95% CI -0.23 to 0.09) NCT00500760 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Cisplatin Other / unclassified 75 mg/m2 Intravenous
Subject Cisplatin Other / unclassified 100 mg/m2 Intravenous
Subject Panitumumab Monoclonal antibody 9 mg/kg Intravenous