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

May 13, 2002
August 6, 2012
October 2001
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Complete list of historical versions of study NCT00036647 on ClinicalTrials.gov Archive Site
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OSI-774 (Tarceva) in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer
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

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).

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Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Carcinoma, Non-small-cell Lung
Drug: Tarceva (erlotinib HCl, OSI-774 )
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
731
January 2003
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  • 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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada,   Germany,   Israel,   Australia,   Mexico,   Argentina,   Thailand,   Romania,   South Africa,   Brazil,   New Zealand,   Chile,   Sweden,   Singapore,   China,   Greece,   United States
 
NCT00036647
BR.21
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OSI Pharmaceuticals
NCIC Clinical Trials Group
Principal Investigator: Frances Shephard, M.D. Princess Margaret Hospital, Canada
Astellas Pharma Inc
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP