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.
Full Title of Study: “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 Type: Interventional
- Study Design
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Drug: Exisulind
Participating in This Clinical Trial
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.
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.
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- Astellas Pharma Inc
- OSI Pharmaceuticals
- Provider of Information About this Clinical Study
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