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:	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:

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
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:

Peter Langmuir, MD

AstraZeneca

More Information

Additional Information:

Cancer Study Locator (US and Canada only) This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Peter Langmuir, AstraZeneca
ClinicalTrials.gov Identifier:	NCT00450138 History of Changes
Obsolete Identifiers:	NCT00411710
Other Study ID Numbers:	D4200C00062
Study First Received:	March 20, 2007
Last Updated:	December 3, 2010
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 February 12, 2012