Open Label, Phase I ZD6474 Head and Neck Cancer Study - Full Text View

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00450138

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 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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Head and Neck Cancer

Drug Information available for: Cisplatin Vandetanib

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 ]

Estimated Enrollment:	48
Study Start Date:	December 2006
Estimated Study Completion Date:	November 2011
Estimated Primary Completion Date:	December 2009 (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

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
Houston, Texas, United States
Research Site
Dallas, Texas, United States

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

Peter Langmuir, MD

AstraZeneca

More Information

Additional Information:

US and Canada only This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	D4200C00062
Study First Received:	March 20, 2007
Last Updated:	September 22, 2009
ClinicalTrials.gov Identifier:	NCT00450138 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

Squamous Cell Carcinoma

Additional relevant MeSH terms:

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

ClinicalTrials.gov processed this record on November 05, 2009