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Phase II Study of Taxotere in Combination With Exisulind in Non-Small Cell Lung Cancer (NSCLC) Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00072618
Recruitment Status : Completed
First Posted : November 7, 2003
Last Update Posted : October 20, 2011
Sponsor:
Collaborator:
OSI Pharmaceuticals
Information provided by (Responsible Party):
Astellas Pharma Inc

Brief Summary:
The purpose of this study is to determine if the combination of Taxotere and exisulind is an effective and safe treatment for patients with advanced NSCLC who have failed a prior platinum-containing regimen.

Condition or disease Intervention/treatment Phase
NSCLC Drug: Exisulind Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Enrollment : 52 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II Multi-Center Study of Weekly Taxotere (Docetaxel) in Combination With Aptosyn (Exisulind) in Non-Small Cell Lung Cancer (NSCLC) Patients Who Have Failed a Prior Platinum-Containing Regimen
Study Start Date : October 2001
Actual Study Completion Date : August 2003

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Histologically documented advanced cancer or advanced platinum-refractory non-small cell lung cancer. Platinum refractory defined as progressive disease during a platinum regimen or within 6 months following treatment.

Negative serum pregnancy test, if fertile female. Have not taken sulindac (Clinoril®) on regular basis for any indication for one week prior to enrollment and willing to remain off of sulindac for the duration of the study.

> 18 years or of legal age. Male patients, or non-pregnant and non-lactating female patients either using adequate birth control (oral contraceptives or Provera), surgically sterile or post-menopausal.

Willingness to remain off chronic NSAIDs (with the exception of ibuprofen, naproxen, or aspirin) for duration of the study. Low dose aspirin for cardiovascular prevention is acceptable.

No treatment with any other chemotherapy or radiotherapy within 2 weeks prior to entering the study.

Exclusion Criteria:

Any condition or any medication which may interfere with the conduct of the study.

Known hypersensitivity to sulindac (Clinoril®) or taxanes. Use of an investigational medication or device within one month of initiating study therapy.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00072618


Locations
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United States, Colorado
University of Colorado Health Sciences Center
Aurora, Colorado, United States, 80045
United States, Illinois
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
Astellas Pharma Inc
OSI Pharmaceuticals

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Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00072618     History of Changes
Obsolete Identifiers: NCT00036010
Other Study ID Numbers: 026B
First Posted: November 7, 2003    Key Record Dates
Last Update Posted: October 20, 2011
Last Verified: October 2011

Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Sulindac sulfone
Sulindac
Docetaxel
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Anticarcinogenic Agents
Protective Agents
Physiological Effects of Drugs
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Antirheumatic Agents