CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 21 enrolled
Drug / intervention
Amifostine +3 moredrug
Likely dose
Amifostine 500 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00270790
NCT00270790Phase 2Completed

A SINGLE SITE EVALUATION OF AMIFOSTINE FOR MUCOSAL AND HEMOPOETIC PROTECTION AND CONCURRENT CARBOPLATIN, TAXOL, RADIOTHERAPY IN THE MANAGEMENT OF PATIENTS WITH ADVANCED LOCOREGIONAL SQUAMOUS CELL CARCINOMAS OF THE HEAD AND NECK.

Mohan Suntharalingam·interventional·Posted Dec 28, 2005·Updated Feb 1, 2017

In Brief

A Phase 2 clinical trial evaluating Amifostine, Carboplatin, and 2 other interventions for Head and Neck Cancer. Completed, enrolled 21 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsMedImmune LLC

Timeline

Phase 2CompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 28, 2005
Enrollment StartMay 1, 2002
Primary CompletionDec 1, 2005
Study CompletionFeb 1, 2009
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 20.5 years ago

Interventions

Amifostinedrug

Amifostine will be given at dose of 500 mg IV within one hour before radiation

Carboplatindrug

Carboplatin for 100 mg/m2 and will be administered after the taxol infusion

Taxoldrug

Taxol will be given at a dose of 40 mg/m2 as a 3 hour infusion dose

Radiotherapydevice

Radiation will be given at a dose of 1.8 Gy. for a total of 70.2 Gy