Randomized Amifostine For SCCHN

Status Completed

Clinical Trial Summary

This research study is studying a drug called Amifostine as a treatment for squamous cell carcinoma in the head and/or neck area.

Clinical Trial Description

Amifostine is a drug that is used to treat moderate to severe xerostomia (dry mouth) for those who receive radiation therapy for head and neck cancer. It was approved by the FDA for use intravenously. This study plans to examine the effects of xerostomia when Amifostine is used subcutaneously (by injection). Amifostine has been seen to be effective when used to combat the effects of dry mouth, but also has some side effects which are listed later in this consent form.

The purpose of this study is to examine the effectiveness of twice a day radiation therapy given with chemotherapy consisting of carboplatin and paclitaxel (Taxo 1). This study will examine the effectiveness of adding Amifostine in the hopes of reducing the side effects of radiation. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00095927
Study type	Interventional
Source	Dana-Farber Cancer Institute
Contact
Status	Completed
Phase	Phase 2
Start date	May 2003
Completion date	June 2008

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