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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Head and Neck Neoplasms
Neoplasms
Neoplasms by Site
Cisplatin
Gefitinib
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Kinase Inhibitors
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014