drugset / Trial / NCT00176605
Phase II Metronomic Dosing, Etoposide, Cyclophosphamide, D0 Prostate Cancer
Phase 2
Completed
15 enrolled
Rutgers, The State University of New Jersey
Bristol-Myers Squibb · collabNational Cancer Institute (NCI) · collab
NaSingle-groupOpen-labelTreatment
Summary
Based on data supporting the use of cyclophosphamide and etoposide both as single agents in combination and a Phase I study showing acceptable toxicity with a chronic dosing regimen, we propose a Phase II clinical trial. This protocol establishes a model that will test the hypothesis that the use of etoposide and cyclophosphamide early in the course of prostate cancer progression, when fewer tumor cells are present, will have greater anti-tumor activity. We plan to treat patients with stage D0 prostate cancer to assess toxicity and anti-tumor activity.
Timeline
- Start
- 2005-05
- Primary completion
- 2008-10
- Completion
- 2008-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cyclophosphamide | Other / unclassified | 50 mg | Oral |
| Subject | Etoposide | Small molecule | 50 mg | Oral |