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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 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2017-02-01

Study results available
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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.

Conditions

Interventions

DRUG

Amifostine

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

DRUG

Carboplatin

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

DRUG

Taxol

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

DEVICE

Radiotherapy

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

Sponsors & Collaborators

  • MedImmune LLC

    collaborator INDUSTRY

  • Mohan Suntharalingam

    lead OTHER

Principal Investigators

  • Mohan Suntharalingam, MD · University of Maryland

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-05-31
Primary Completion
2005-12-31
Completion
2009-02-28

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00270790 on ClinicalTrials.gov