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
18 Years
N/A
Both
Head and Neck Cancer
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 Site | Boulder, Colorado |
| Research Site | Arlington Heights, Illinois |
| Research Site | Abilene, Texas |
