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Open Label, Phase I ZD6474 Head and Neck Cancer Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00450138
First received: March 20, 2007
Last updated: July 4, 2012
Last verified: July 2012
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
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:

U.S. FDA Resources

Further study details as provided by AstraZeneca:

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 ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
AstraZeneca
Investigators
Study Director: James Vasselli, MD AstraZeneca
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00450138     History of Changes
Obsolete Identifiers: NCT00411710
Other Study ID Numbers: D4200C00062
Study First Received: March 20, 2007
Last Updated: July 4, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
Squamous Cell Carcinoma

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
 Neoplasms by Site
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 16, 2013