drugset / Trial / NCT00096174

Phase II Study of Concurrent C225, Cisplatin and Radiation in Stage IV Squamous Cell Carcinoma of the Head and Neck

NCT00096174 ↗

NaSingle-groupOpen-labelTreatment

Summary

RATIONALE: Monoclonal antibodies such as cetuximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Cetuximab may make the tumor cells more sensitive to radiation therapy and chemotherapy. Giving monoclonal antibody therapy together with chemoradiotherapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving cetuximab and cisplatin together with radiation therapy works in treating patients with locally advanced or regional stage IV head and neck cancer that cannot be removed by surgery.

Timeline

Start
2005-04-08
Primary completion
2009-07
Completion
2016-07

Publications

  • Results Langer CJ, Lee JW, Patel UA, et al.: Preliminary analysis of ECOG 3303: concurrent radiation (RT), cisplatin (DDP) and cetuximab (C) in unresectable, locally advanced (LA) squamous cell carcinoma of the head and neck (SCCHN). [Abstract] J Clin Oncol 26 (Suppl 15): A-6006, 2008.

Drugs

EvaluationDrugModalityDoseRoute
Subject Cetuximab Monoclonal antibody 250 mg/m2 Intravenous
Subject Cisplatin Other / unclassified 75 mg/m2 Intravenous

Indications