drugset / Trial / NCT00270790

EVALUATION OF AMIFOSTINE FOR MUCOSAL AND HEMOPOETIC PROTECTION AND CARBOPLATIN, TAXOL, RADIOTHERAPY IN THE MANAGEMENT OF PATIENTS WITH HEAD AND NECK CANCER.(GCC 0202)

NCT00270790

Phase 2 Completed 21 enrolled Mohan Suntharalingam MedImmune LLC · collab
Non-randomizedSingle-groupOpen-labelTreatment

Summary

Purpose of this study: There is some evidence that the best treatment for head and neck cancer involves a combination of radiation therapy and chemotherapy. Radiation therapy is a form of cancer treatment using high energy x-rays. Chemotherapy is a form of cancer treatment that uses special medications. This study uses two chemotherapy drugs (Taxol and Carboplatin), which are FDA approved for treating head and neck cancers. This treatment combination has been associated with difficulty, pain, or a burning sensation upon swallowing (called esophagitis), and decrease in blood cells (cells in the blood which fight against infection). The purpose of this study is to investigate whether the addition of another drug, Amifostine, can reduce the side effects of current combination treatment (radiation and chemotherapy which is standard of care). The addition of Amifostine is the investigational part of the study. The research study is also looking at the side effects of Amifostine and cancer's growth response to this combination treatment.

Timeline

Start
2002-05
Primary completion
2005-12
Completion
2009-02

Drugs

EvaluationDrugModalityDoseRoute
Subject amifostine Unknown 500 mg Intravenous
Background Carboplatin Small molecule 100 mg/m2
Background Paclitaxel Small molecule 40 mg/m2