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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00239304
First received: October 13, 2005
Last updated: December 14, 2007
Last verified: December 2007
  Purpose

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.


Condition Intervention Phase
Head and Neck Neoplasms
Drug: Gefitinib
Drug: Cisplatin
Procedure: Radiotherapy
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I/II Trial of ZD1839 (Iressa) Given Concurrently With Cisplatin and Radiotherapy in Patients With Locally Advanced Head and Neck Cancer

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Parts 1 and 2: Safety (Incidence of DLTs)
  • Part 3: Safety and tolerability

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 40
Study Start Date: June 2003
Study Completion Date: March 2006
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00239304

Locations
Finland
Research Centre
Helsinki, Finland
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: AstraZeneca Finland Medical Director, MD AstraZeneca
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00239304     History of Changes
Other Study ID Numbers: 1839IL/0151
Study First Received: October 13, 2005
Last Updated: December 14, 2007
Health Authority: Finland: Finnish Medicines Agency

Keywords provided by AstraZeneca:
Stage III Head and Neck Cancer
Stage IV Head and Neck Cancer

Additional relevant MeSH terms:
Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Gefitinib
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 23, 2014