Trials / Completed
CompletedNCT00085826
A Phase III Study of the Efficacy of Taxotere/Aptosyn Versus Taxotere/Placebo in Non-Small Cell Lung Cancer Patients
A Phase III, Randomized, Double-Blind, Multi-Center Study of the Efficacy of Taxotere (Docetaxel) in Combination With Aptosyn (Exisulind) Versus Taxotere (Docetaxel) and Placebo in Non-Small Cell Lung Cancer (NSCLC) Patients After Failure of Prior Platinum-Based Chemotherapy
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 600 (planned)
- Sponsor
- Astellas Pharma Inc · Industry
- Sex
- —
- Age
- —
- Healthy volunteers
- Not accepted
Summary
Taxotere has been approved by the FDA and is considered a standard treatment for patients with lung cancer who have failed prior platinum-containing regimens. The main purpose of this research study is to determine if Aptosyn, when given in combination with Taxotere, will result in prolonged survival when compared to Taxotere alone. This study will also help determine tumor response rates, and the safety profile of Aptosyn in combination with Taxotere. This study has been completed and a publication is pending.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Exisulind |
Timeline
- Start date
- 2001-04-01
- Completion
- 2004-12-01
- First posted
- 2004-06-17
- Last updated
- 2011-10-20
Locations
114 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00085826. Inclusion in this directory is not an endorsement.