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Docetaxel in Combination With Zactima (ZD6474) in Patients With Locally Advanced Squamous Cell Carcinoma of the the Head and Neck

NCT00459043 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2013-07-03

Study results available
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Summary

In this research study, the researchers are comparing the combination of docetaxel and Zactima with docetaxel alone to see if the combination of the two drugs will be more effective than docetaxel alone. Zactima blocks the actions of three substances in the body: 1)vascular endothelial growth factor reception (VEGFR); 2)epidermal growth factor receptor (EGFR); and 3) rearranged during transfection (RET). VEGFR stimulates the growth of new blood vessels. When certain proteins bind to the VEGF receptor, a process begins to occur which allows new blood vessels to be made that provide blood to the cancer cells. Zactima is thought to block these proteins from binding to the VEGF receptor, which would then block the process that creates new blood vessels. EGFR controls how quickly cells grow and multiply. RET is thought to have a particularly significant role in the development and growth of squamous cell tumors. The actions of Zactima are very different from the way standard chemotherapy drugs work. Researchers believe that Zactima might have different side effects from other cancer treatments so another one of the purposes of this study is to assess the side effects caused by the drug.

Conditions

  • Squamous Cell Carcinoma of Head and Neck

Interventions

DRUG

ZD6474

Taken orally once every morning

DRUG

Docetaxel

Given on the first day of every treatment cycle (every 3 weeks)

Sponsors & Collaborators

  • Brigham and Women's Hospital

    collaborator OTHER

  • Massachusetts General Hospital

    collaborator OTHER

  • Loyola University

    collaborator OTHER

  • AstraZeneca

    collaborator INDUSTRY

  • Dana-Farber Cancer Institute

    lead OTHER

Principal Investigators

  • Robert Haddad, MD · Dana-Farber Cancer Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-03-31
Primary Completion
2010-03-31
Completion
2012-02-29

Countries

  • United States

Study Locations

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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 NCT00459043 on ClinicalTrials.gov