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C-TPF in Patients With Newly Diagnosed Locally Advanced Squamous Cell Carcinoma of the Head and Neck

NCT00402545 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2009-11-02

No results posted yet for this study

Summary

The purpose of this research study is to determine the safest and most effective dose of 5-FU that can be given with docetaxel (Taxotere), Cisplatin and cetuximab to patients with newly diagnosed locally advanced squamous cell carcinoma of the head and neck. We will also be studying the toxicity of this regimen of 4 drugs and the tumor response.

Conditions

  • Head and Neck Neoplasms

Interventions

DRUG

Cetuximab

Given intravenously on days 1, 8 and 15 of each 21-day cycle for three cycles

DRUG

Docetaxel

Given intravenously on day 1 of each 21-day cycle for 3 cycles

DRUG

Cisplatin

Intravenously on day 1 of each 21-day cycle for 3 cycles

DRUG

5-Fluorouracil

Given by continuous infusion pump over a period of 96 hours(dosage wil vary depending upon when participant enrolls in trial)

Sponsors & Collaborators

Principal Investigators

  • Robert I Haddad, MD · Dana-Farber Cancer Institute

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
2007-01-31
Primary Completion
2009-07-31
Completion
2009-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

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 NCT00402545 on ClinicalTrials.gov