Open Label, Phase I ZD6474 Head and Neck Cancer Study

Sanofi

Status and phase: Completed; Phase 1

Conditions: Head and Neck Cancer

Treatments: Drug: ZD6474 (vandetanib); Radiation: Radiation; Drug: Cisplatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00450138

D4200C00062

Details and patient eligibility

About

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.

Enrollment: 48 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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48 participants in 2 patient groups

1

Experimental group

Description:

Radiation + vandetanib

Treatment:

Radiation: Radiation

Drug: ZD6474 (vandetanib)

2

Experimental group

Description:

Radiation + cisplatin + vandetanib

Treatment:

Drug: Cisplatin

Radiation: Radiation

Drug: ZD6474 (vandetanib)