Status:
COMPLETED
Phase II Study of Taxotere in Combination With Exisulind in Non-Small Cell Lung Cancer (NSCLC) Patients
Lead Sponsor:
Astellas Pharma Inc
Collaborating Sponsors:
OSI Pharmaceuticals
Conditions:
NSCLC
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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 r...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2001
Trial Type :
INTERVENTIONAL
End Date :
August 1 2003
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT00072618
Start Date
October 1 2001
End Date
August 1 2003
Last Update
October 20 2011
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Colorado Health Sciences Center
Aurora, Colorado, United States, 80045
2
University of Chicago Medical Center
Chicago, Illinois, United States, 60637