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| Sponsor: | Astellas Pharma Inc |
|---|---|
| Collaborator: |
OSI Pharmaceuticals |
| Information provided by (Responsible Party): | Astellas Pharma Inc |
| ClinicalTrials.gov Identifier: | NCT00072618 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
NSCLC |
Drug: Exisulind |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| United States, Colorado | |
| University of Colorado Health Sciences Center | |
| Aurora, Colorado, United States, 80045 | |
| United States, Illinois | |
| University of Chicago Medical Center | |
| Chicago, Illinois, United States, 60637 | |
More Information
| Responsible Party: | Astellas Pharma Inc |
| ClinicalTrials.gov Identifier: | NCT00072618 History of Changes |
| Obsolete Identifiers: | NCT00036010 |
| Other Study ID Numbers: | 026B |
| Study First Received: | November 5, 2003 |
| Last Updated: | October 18, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Sulindac sulfone Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
Anticarcinogenic Agents Protective Agents Physiological Effects of Drugs Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Anti-Inflammatory Agents Central Nervous System Agents Antirheumatic Agents |
