The IRESSA Novel Head and Neck Chemotherapy Evaluation Study

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00255476
First received: November 17, 2005
Last updated: April 22, 2009
Last verified: April 2009
  Purpose

The purpose of this study is to compare the objectie tumour response rate between the cisplatin/5FU and cisplatin/5FU plus ZD1839 combination


Condition Intervention Phase
Squamous Cell Cancer
Cancer of Head and Neck
Drug: gefitinib
Drug: cisplatin
Drug: 5-flourouracil
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomised Phase II Study to Investigate the Feasibility and Benefits of Combining ZD1839 and Cisplatin/5FU, as Induction Therapy, in Patients With Locally and Advanced Squamous Cell Carcinoma of the Head and Neck

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • To compare the objective tumour response rate between cisplatin/5FU and cisplatin/5FU and ZD1839 combination in these patients

Secondary Outcome Measures:
  • To compare safety and tolerability in these patients

Estimated Enrollment: 64
Study Start Date: February 2004
Study Completion Date: July 2007
  Eligibility

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

Inclusion Criteria:

  • Provision of written informed consent
  • Patients with histologically proven primary SCCHN
  • Aged 18 or over

Exclusion Criteria:

  • Patients eligible for surgery with curative intent
  • Other co-existing malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ
  • Exclude UCNT
  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: NCT00255476

Locations
United Kingdom
Research Site
London, United Kingdom
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: AstraZeneca Iressa Medical Sciences Director, MD AstraZeneca
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00255476     History of Changes
Other Study ID Numbers: 1839IL/0544
Study First Received: November 17, 2005
Last Updated: April 22, 2009
Health Authority: United Kingdom: Department of Health

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Neoplasms, Squamous Cell
Head and Neck Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms by Site
Gefitinib
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 01, 2014