Open Label, Phase I ZD6474 Head and Neck Cancer Study

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00450138

Enrollment

Registered

2007-03-21

Start date

2006-12-31

Completion date

2011-11-30

Last updated

2016-08-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head and Neck Cancer

Keywords

Squamous Cell Carcinoma

Brief summary

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.

Interventions

DRUGZD6474 (vandetanib)

once daily oral dose

DRUGCisplatin

intravenous infusion

RADIATIONRadiation

radiation of head and neck

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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	assessed at each visit

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026