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

Phase 1

Completed

• Conditions: NSCLC

• Registration Number: NCT00072618
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-10
• Study Completion: 2003-08
• Study First Submitted: 2003-11-05
• Study First Submitted QC: 2003-11-06
• Study First Posted: 2003-11-07
• Status Verified: 2011-10
• Last Update Submitted: 2011-10-18
• Last Update Posted: 2011-10-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Trial Locations

Locations (2)

University of Colorado Health Sciences Center; 🇺🇸 Aurora, Colorado, United States

University of Chicago Medical Center; 🇺🇸 Chicago, Illinois, United States