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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


Phase 1
18 Years
N/A
Not Enrolling
Both
Head and Neck Cancer

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

assessed at each visit

Safety Issue:

Yes

Principal Investigator

James Vasselli, MD

Investigator Role:

Study Director

Investigator Affiliation:

AstraZeneca

Authority:

United States: Food and Drug Administration

Study ID:

D4200C00062

NCT ID:

NCT00450138

Start Date:

December 2006

Completion Date:

November 2011

Related Keywords:

  • Head and Neck Cancer
  • Squamous Cell Carcinoma
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms

Name

Location

Research SiteBoulder, Colorado  
Research SiteArlington Heights, Illinois  
Research SiteAbilene, Texas