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

AstraZeneca40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Head and Neck Neoplasms

Interventions

GefitinibDRUG

CisplatinDRUG

RadiotherapyPROCEDURE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Research Centre

Helsinki, Finland

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

Data from ClinicalTrials.gov

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