A Phase I/II Trial of ZD1839 (Iressa) Given Concurrently With Cisplatin and Radiotherapy in Patients With Locally Advanced Head and Neck Cancer

AstraZeneca1 site in 1 country40 target enrollmentJune 2003

ConditionsHead and Neck Neoplasms

DrugsGefitinib Cisplatin

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Head and Neck Neoplasms
Sponsor: AstraZeneca
Enrollment: 40
Locations: 1
Primary Endpoint: Parts 1 and 2: Safety (Incidence of DLTs)
Status: Completed
Last Updated: 18 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

To determine the safety and tolerability of gefitinib in combination with cisplatin and radiation (3D-CRT or IMRT) in patients with locally advanced head and neck cancer.

Registry

clinicaltrials.gov

Start Date

June 2003

End Date

March 2006

Last Updated

18 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

AstraZeneca

Eligibility Criteria

Inclusion Criteria

•Histologically confirmed head and neck cancer
•Lymph node negative or positive
•Metastasis negative
•Chemo- and radiotherapy naïve
•Measurable disease by RECIST
•Written informed consent

Exclusion Criteria

•Severe alcohol abuse
•Active ILD
•Co-existing chronic gastrointestinal disease(s)
•Brain metastasis

Outcomes

Primary Outcomes

Parts 1 and 2: Safety (Incidence of DLTs)

Part 3: Safety and tolerability

Secondary Outcomes

Parts 2 and 3: Efficacy (Incidence of complete response at 3 months after the end of trial treatment based on RECIST criteria)
Exploratory Outcome: EGFR-1 expression, amplification and activation Serum VEGF levels