drugset / Trial / NCT00521781
Study of Abraxane Plus Hormonal Therapy as Initial Treatment of Unresectable or Metastatic Prostate Cancer
Phase 2
Terminated
14 enrolled
The Methodist Hospital Research Institute
Celgene Corporation · collab
NaSingle-groupOpen-labelTreatment
Summary
The purpose of the clinical trial is to assess the clinical benefit as measured by time to tumor progression of Abraxane plus hormonal therapy when applied to previously untreated patients with unresectable or metastatic adenocarcinoma of the prostate, as well as to assess safety and tolerability of the study drug regimen and to evaluate secondary efficacy endpoints such as overall survival and duration of response.
Timeline
- Start
- 2007-08
- Primary completion
- 2008-09
- Completion
- 2008-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Paclitaxel | Small molecule | 100 mg/m2 | Intravenous |
| Background | Bicalutamide | Other / unclassified | 50 mg | Oral |
| Background | Leuprolide | Other / unclassified | 7.5 mg | — |
| Background | Leuprolide | Other / unclassified | 22.5 mg | — |