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OSI-774 (Tarceva) in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer

This study has been completed.
Sponsor:
Collaborator:
NCIC Clinical Trials Group
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00036647
First received: May 13, 2002
Last updated: August 6, 2012
Last verified: August 2012
History of Changes
  Purpose

The purpose of this study is to determine if OSI-774 will improve overall survival of patients with incurable stage IIIB/IV non-small cell lung cancer compared to standard of care. OSI-774 is a new type of drug under evaluation called an epidermal growth factor receptor (EGFR). OSI-774 is an investigational drug that has not yet been approved by the U.S. Food and Drug Administration (FDA).


Condition Intervention Phase
Carcinoma, Non-small-cell Lung
 Drug: Tarceva (erlotinib HCl, OSI-774 )
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Randomized Placebo Controlled Study of OSI-774 (Erlotinib HCl, Tarceva[TM]) in Patients With Incurable Stage IIIB/IV Non-small Cell Lung Cancer Who Have Failed Standard Therapy for Advanced or Metastatic Disease

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer
U.S. FDA Resources

Further study details as provided by Astellas Pharma Inc:

Enrollment: 731
Study Start Date: October 2001
Study Completion Date: January 2003
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • Clinical diagnosis of stage IIIB or IV non-small cell lung cancer.
  • Must have evidence of disease (clinical or radiological).
  • Have failed 1 but no more than 2 prior chemotherapy regimens, have recovered from any side effects and have not had any chemotherapy for at least 21 days.
  • If the patient has had surgery, the surgery was at least 2 weeks ago.
  • Patients whose cancer has spread to their brain or central nervous system are eligible, providing that they have been on stable dose of steroids for at least 4 weeks and are free of symptoms.
  • If the patient received radiation therapy, treatment was at least 4 weeks ago.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00036647

  Show 97 Study Locations
Sponsors and Collaborators
OSI Pharmaceuticals
NCIC Clinical Trials Group
Investigators
Principal Investigator: Frances Shephard, M.D. Princess Margaret Hospital, Canada
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00036647     History of Changes
Obsolete Identifiers: NCT00026325
Other Study ID Numbers: BR.21
Study First Received: May 13, 2002
Last Updated: August 6, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Astellas Pharma Inc:
Non-Small Cell Lung Cancer
Tarceva
EGFR
erlotinib

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
 Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Erlotinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013