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



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

For Condition: NSCLC
Status: Recruiting
Sponsor(s): OSI Pharmaceuticals ,
Synopsis: 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.
Details:
Eligibility:
Study Type:  Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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.
Total Enrollment: 52

Location and Contact Information:

University of Chicago Medical Center *Recruiting*
Chicago,  Illinois,  60637
United States
Recruiting OSIP  Information 800-572-1932

University of Colorado Health Sciences Center *Recruiting*
Denver,  Colorado,  80262
United States
Recruiting OSIP  Information 800-572-1932


Additional Information:
Study ID Numbers:  026B; 
Study Start Date: October 2001
Record last reviewed: November 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00072618

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

2. Inhaled Doxorubicin Plus IV Docetaxel and Cisplatin in Patients with Non-Small-Cell Lung Carcinoma (NSCLC)

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