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| Descriptive Information Fields | |
| Brief Title † | Phase II Study of Taxotere in Combination With Exisulind in Non-Small Cell Lung Cancer (NSCLC) Patients |
| 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 |
| 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 | |
| Study Phase | Phase I, Phase II |
| Study Type † | Interventional |
| Study Design † | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Primary Outcome Measure † | |
| Secondary Outcome Measure † | |
| Condition † | NSCLC |
| Intervention † | Drug: Exisulind |
| MEDLINE PMIDs | |
| Links | |
| Recruitment Information Fields | |
| Recruitment Status † | Completed |
| Enrollment † | 52 |
| Start Date † | October 2001 |
| Completion Date | August 2003 |
| Eligibility 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. |
| Gender | Both |
| Ages | 18 Years and older |
| Accepts Healthy Volunteers | No |
| Contacts †† | |
| Location Countries † | United States |
| Administrative Information Fields | |
| NCT ID † | NCT00072618 |
| Organization ID | 026B |
| Secondary IDs †† | |
| Study Sponsor † | OSI Pharmaceuticals |
| Collaborators †† | |
| Investigators † | |
| Information Provided By | OSI Pharmaceuticals |
| Verification Date | August 2003 |
| First Received Date † | November 5, 2003 |
| Last Updated Date | October 10, 2006 |
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