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Sponsored by: |
AstraZeneca |
---|---|
Information provided by: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00450138 |
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 I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 48 |
Study Start Date: | December 2006 |
Estimated Study Completion Date: | May 2012 |
Estimated Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Radiation + vandetanib
|
Drug: ZD6474 (vandetanib)
once daily oral dose
Radiation: Radiation
radiation of head and neck
|
2: Experimental
Radiation + cisplatin + vandetanib
|
Drug: ZD6474 (vandetanib)
once daily oral dose
Drug: Cisplatin
intravenous infusion
Radiation: Radiation
radiation of head and neck
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: AstraZeneca Cancer Locator Service | 877-400-4656 | astrazeneca@emergingmed.com |
United States, Colorado | |
Research Site | Recruiting |
Denver, Colorado, United States | |
United States, Illinois | |
Research Site | Recruiting |
Chicago, Illinois, United States | |
United States, Texas | |
Research Site | Recruiting |
Houston, Texas, United States |
Study Director: | Peter Langmuir, MD | AstraZeneca |
Study ID Numbers: | D4200C00062 |
Study First Received: | March 20, 2007 |
Last Updated: | April 8, 2009 |
ClinicalTrials.gov Identifier: | NCT00450138 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Squamous Cell Carcinoma |
Radiation-Sensitizing Agents Cisplatin Head and Neck Neoplasms Epidermoid Carcinoma Neoplasms, Squamous Cell |
Squamous Cell Carcinoma Carcinoma, Squamous Cell Neoplasms, Glandular and Epithelial Carcinoma |
Neoplasms by Histologic Type Antineoplastic Agents Physiological Effects of Drugs Pharmacologic Actions Carcinoma Neoplasms Neoplasms by Site |
Cisplatin Radiation-Sensitizing Agents Head and Neck Neoplasms Therapeutic Uses Neoplasms, Squamous Cell Carcinoma, Squamous Cell Neoplasms, Glandular and Epithelial |