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

Tracking Information

First Received Date ^ICMJE

May 13, 2002

Last Updated Date

December 16, 2005

Start Date ^ICMJE

October 2001

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00036647 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

A Randomized Placebo Controlled Study of OSI-744 (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

Brief Summary

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).

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Carcinoma, Non-Small-Cell Lung

Intervention ^ICMJE

Drug: Tarceva (erlotinib HCl, OSI-774 )

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

700

Completion Date

January 2003

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Argentina, Australia, Brazil, Canada, Chile, China, Germany, Greece, Israel, Mexico, New Zealand, Romania, Singapore, South Africa, Sweden, Thailand

Administrative Information

NCT ID ^ICMJE

NCT00036647

Responsible Party

Study ID Numbers ^ICMJE

OSI-774-BR.21

Study Sponsor ^ICMJE

OSI Pharmaceuticals

Collaborators ^ICMJE

NCIC Clinical Trials Group

Investigators ^ICMJE

Study Chair:

Frances Shepherd, M.D.

Information Provided By

OSI Pharmaceuticals

Verification Date

February 2003

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