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Docetaxel and Capecitabine for First Line Treatment of Metastatic Squamous Cell Carcinoma of the Head & Neck

NCT00216138 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2011-05-02

No results posted yet for this study

Summary

Recent progress in treatment of recurrent/metastatic SCCHN has been made with the introduction of the taxanes. Docetaxel as a single agent has a response rate of 22-42% and 17% in patients with recurrent disease. Capecitabine is an oral fluoropyrimidine prodrug that is converted into 5-FU. Previous studies have shown that the capecitabine/docetaxel combination has a synergistic inhibition of tumor growth, resulting in significantly superior efficacy in time to disease progression (TTP), overall survival, median survival and objective tumor response rate compared to docetaxel alone.

This trial will investigate the efficacy the combination of docetaxel and capecitabine in treating patients with recurrent/metastatic SCCHN.

Conditions

Interventions

DRUG

Docetaxel

Docetaxel 60 mg/m2 for 60 minutes, day 1 of each cycle

DRUG

Capecitabine

Capecitabine 825 mg/m2 po bid, days 1-14

DRUG

Premedication

Dexamethasone and antiemetic premedication

Sponsors & Collaborators

  • Sanofi

    collaborator INDUSTRY

  • Hoffmann-La Roche

    collaborator INDUSTRY

  • Walther Cancer Institute

    collaborator OTHER

  • Hoosier Cancer Research Network

    lead OTHER

Principal Investigators

  • David Potter, M.D. · Hoosier Oncology Group, LLC

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-03-31
Primary Completion
2007-09-30
Completion
2007-09-30

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
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 NCT00216138 on ClinicalTrials.gov