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

This study has been completed.

First Received: June 15, 2004 Last Updated: October 10, 2006 History of Changes

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

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

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Sulindac sulfone Docetaxel

U.S. FDA Resources

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:

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

Additional Information:

OSI Website This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	028
Study First Received:	June 15, 2004
Last Updated:	October 10, 2006
ClinicalTrials.gov Identifier:	NCT00085826 History of Changes
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:

Anti-Inflammatory Agents
Thoracic Neoplasms
Anticarcinogenic Agents
Cyclooxygenase Inhibitors
Sulindac sulfone
Carcinoma
Docetaxel
Respiratory Tract Diseases
Analgesics, Non-Narcotic
Lung Neoplasms

Lung Diseases
Non-small Cell Lung Cancer
Anti-Inflammatory Agents, Non-Steroidal
Peripheral Nervous System Agents
Analgesics
Sulindac
Antirheumatic Agents
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Thoracic Neoplasms
Anticarcinogenic Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Docetaxel
Neoplasms by Site
Respiratory Tract Diseases
Sensory System Agents
Lung Neoplasms
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Respiratory Tract Neoplasms

Neoplasms by Histologic Type
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Sulindac sulfone
Protective Agents
Pharmacologic Actions
Carcinoma
Neoplasms
Analgesics, Non-Narcotic
Lung Diseases
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on July 02, 2009