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Open Label, Phase I ZD6474 Head and Neck Cancer Study

This study has been completed.
Information provided by (Responsible Party):
Sanofi Identifier:
First received: March 20, 2007
Last updated: August 26, 2016
Last verified: August 2016
The purpose of this study is to determine the maximum tolerated dose of ZD6474 given in combination with radiation or in combination with chemotherapy and radiation in patients with squamous cell carcinoma of the head and neck.

Condition Intervention Phase
Head and Neck Cancer
Drug: ZD6474 (vandetanib)
Drug: Cisplatin
Radiation: Radiation
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label Phase 1 Study to Assess the Maximum Tolerated Dose of ZACTIMA™ Given Concomitantly With Weekly Cisplatin Chemotherapy and Radiation Therapy in Patients With Previously Untreated, Unresected Stage III-IV Head and Neck Squamous Cell Carcinoma

Resource links provided by NLM:

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • To determine the maximum tolerated dose of vandetanib given in combination with radiation or radiation and chemotherapy in patients with late stage head and neck cancer [ Time Frame: assessed at each visit ]

Enrollment: 48
Study Start Date: December 2006
Study Completion Date: November 2011
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Radiation + vandetanib
Drug: ZD6474 (vandetanib)
once daily oral dose
Other Name: ZACTIMA™
Radiation: Radiation
radiation of head and neck
Experimental: 2
Radiation + cisplatin + vandetanib
Drug: ZD6474 (vandetanib)
once daily oral dose
Other Name: ZACTIMA™
Drug: Cisplatin
intravenous infusion
Radiation: Radiation
radiation of head and neck


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Stage III-IV squamous cell carcinoma of the head and neck

Exclusion Criteria:

  • No previous treatment for head and neck cancer, adequate cardiac function
  Contacts and Locations
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Please refer to this study by its identifier: NCT00450138

United States, Colorado
Research Site
Denver, Colorado, United States
United States, Illinois
Research Site
Chicago, Illinois, United States
United States, Texas
Research Site
Dallas, Texas, United States
Research Site
Houston, Texas, United States
Sponsors and Collaborators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

Additional Information:
Responsible Party: Sanofi Identifier: NCT00450138     History of Changes
Obsolete Identifiers: NCT00411710
Other Study ID Numbers: D4200C00062
Study First Received: March 20, 2007
Last Updated: August 26, 2016

Keywords provided by Sanofi:
Squamous Cell Carcinoma

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Antineoplastic Agents processed this record on May 25, 2017