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Effect of Iressa With/Without Concurrent Chemoradiotherapy on Tumor Gene Expression Profiles in Patients With Advanced Non-Nasopharyngeal Head and Neck Carcinoma

NCT00228488 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2007-12-19

No results posted yet for this study

Summary

Two different patient populations will be targeted for this study. The first population (SP1) will include patients with recurrent/metastatic head and neck cancers, excluding salivary gland carcinomas. The second population (SP2) will include treatment-naïve patients with locally advanced squamous cell head and neck cancer (SCHNC).

SP1 will be treated with palliative intent and the patients can be treatment-naïve or have received prior chemotherapy. Study treatment will consist of Iressa (gefitinib) alone.

SP2 will be treated with radical intent. The patients must be treatment-naïve and study treatment will consist of induction Iressa for 3 weeks followed by a combination of Iressa plus cisplatin and concurrent irradiation.

Conditions

Interventions

DRUG

Gefitinib

Sponsors & Collaborators

Principal Investigators

  • AstraZeneca Medical Department · AstraZeneca

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-06-30
Completion
2005-12-31

Countries

  • Hong Kong
  • Singapore

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00228488 on ClinicalTrials.gov