A Phase III Study of the Efficacy of Taxotere/Aptosyn Versus Taxotere/Placebo in Non-Small Cell Lung Cancer Patients - Full Text View

Purpose

Taxotere has been approved by the FDA and is considered a standard treatment for patients with lung cancer who have failed prior platinum-containing regimens. The main purpose of this research study is to determine if Aptosyn, when given in combination with Taxotere, will result in prolonged survival when compared to Taxotere alone.

This study will also help determine tumor response rates, and the safety profile of Aptosyn in combination with Taxotere.

This study has been completed and a publication is pending.

Condition	Intervention	Phase
Non-Small Cell Lung Cancer	Drug: Exisulind	Phase III

MedlinePlus related topics:

Cancer Lung Cancer

Drug Information available for:

Docetaxel Sulindac sulfone

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	A Phase III, Randomized, Double-Blind, Multi-Center Study of the Efficacy of Taxotere (Docetaxel) in Combination With Aptosyn (Exisulind) Versus Taxotere (Docetaxel) and Placebo in Non-Small Cell Lung Cancer (NSCLC) Patients After Failure of Prior Platinum-Based Chemotherapy

Further study details as provided by OSI Pharmaceuticals:

Estimated Enrollment:	600
Study Start Date:	April 2001
Estimated Study Completion Date:	December 2004

Eligibility

Accepts Healthy Volunteers:

No

Criteria

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00085826

Show 114 Study Locations

Sponsors and Collaborators

OSI Pharmaceuticals

More Information

OSI Website This link exits the ClinicalTrials.gov site

Study ID Numbers:	028
First Received:	June 15, 2004
Last Updated:	October 10, 2006
ClinicalTrials.gov Identifier:	NCT00085826
Health Authority:	United States: Food and Drug Administration

Keywords provided by OSI Pharmaceuticals:

Lung Cancer

NSCLC

Non-small Cell Lung Cancer

Study placed in the following topic categories:

Docetaxel

Thoracic Neoplasms

Non-small cell lung cancer

Respiratory Tract Diseases

Lung Neoplasms

Lung Diseases

Sulindac

Sulindac sulfone

Carcinoma, Non-Small-Cell Lung

Neoplasms, Glandular and Epithelial

Carcinoma

Additional relevant MeSH terms:

Anti-Inflammatory Agents

Anticarcinogenic Agents

Respiratory Tract Neoplasms

Neoplasms by Histologic Type

Molecular Mechanisms of Pharmacological Action

Antineoplastic Agents

Physiological Effects of Drugs

Cyclooxygenase Inhibitors

Enzyme Inhibitors

Protective Agents

Pharmacologic Actions

Neoplasms

Neoplasms by Site

Sensory System Agents

Analgesics, Non-Narcotic

Therapeutic Uses

Anti-Inflammatory Agents, Non-Steroidal

Peripheral Nervous System Agents

Analgesics

Antirheumatic Agents

Central Nervous System Agents

ClinicalTrials.gov processed this record on November 30, 2008

Sponsored by:	OSI Pharmaceuticals
Information provided by:	OSI Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00085826