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Open Label, Phase I ZD6474 Head and Neck Cancer Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00450138
First Posted: March 21, 2007
Last Update Posted: August 29, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sanofi
  Purpose
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: None (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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00450138


Locations
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
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

Additional Information:
Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00450138     History of Changes
Obsolete Identifiers: NCT00411710
Other Study ID Numbers: D4200C00062
First Submitted: March 20, 2007
First Posted: March 21, 2007
Last Update Posted: August 29, 2016
Last Verified: August 2016

Keywords provided by Sanofi:
Squamous Cell Carcinoma

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Cisplatin
Antineoplastic Agents