Gefitinib (Iressa) in Combo With Chemoradiation in Patients With Locally Advanced Head & Neck Cancer

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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00239304

Enrollment

Registered

2005-10-17

Start date

2003-06-30

Completion date

2006-03-31

Last updated

2007-12-18

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

Conditions

Head and Neck Neoplasms

Keywords

Stage III Head and Neck Cancer, Stage IV Head and Neck Cancer

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.

Interventions

DRUGGefitinib

DRUGCisplatin

PROCEDURERadiotherapy

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Histologically confirmed head and neck cancer * Lymph node negative or positive * Metastasis negative * Chemo- and radiotherapy naïve * WHO 0-2 * Measurable disease by RECIST * Written informed consent

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Parts 1 and 2: Safety (Incidence of DLTs)	—
Part 3: Safety and tolerability	—

Secondary

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

Countries

Finland

Outcome results

None listed

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