A Phase I Study of ZD1839 and Palliative Thoracic Radiotherapy in Patients With Non-small-cell Lung Cancer

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00255489
First received: November 17, 2005
Last updated: January 24, 2011
Last verified: January 2011
  Purpose

The purpose of this study is to characterize the safety profile of ZD1839 in combination with Palliative thoracic Radiotherapy in patients with non-small cell lung cancer


Condition Intervention Phase
Non-small-cell Lung Cancer
Drug: Gefitinib
Procedure: palliative thoracic radiotherapy
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Study of ZD1839 (Iressa) and Palliative Thoracic Radiotherapy in Patients With Non-small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • To characterize the safety profile of ZD 1839 in these patients

Secondary Outcome Measures:
  • To measure the quality of life compared to baseline
  • To measure the change in disease related symptoms compared to baseline

Estimated Enrollment: 36
Study Start Date: May 2004
Study Completion Date: June 2006
  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 requiring low dose palliative thoracic irradiation to a field size of less than or equal to 150cm2
  • Histologically or cytologically conformed non-small cell lung cancer
  • Aged 18 or over

Exclusion Criteria:

  • Previous thoracic radiotherapy
  • Any condition that may pre-dispose the patient to suffer an individual drug-relaged DLT (dose limiting toxicity) event
  • Known hypersensitivity to any component of study medication
  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: NCT00255489

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

No publications provided

ClinicalTrials.gov Identifier: NCT00255489     History of Changes
Other Study ID Numbers: 1839IL/0524
Study First Received: November 17, 2005
Last Updated: January 24, 2011
Health Authority: United Kingdom: Department of Health

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Gefitinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 18, 2014