drugset / Trial / NCT00887640
Impact of Temsirolimus Therapy on Circulating Tumor Cell Biology In Men With Castration Resistant Metastatic Prostate Cancer
NaSingle-groupOpen-labelTreatment
Summary
This is a single arm study of 11 men with treatment refractory metastatic Castrate Resistant Prostate Cancer (CRPC) who will receive temsirolimus IV at a dose of 25 mg weekly until progression. Progression will not include Prostate Specific Antigen (PSA) progression; however, upon PSA progression, the addition of an anti-androgen will be permitted. The primary objective of the study is to evaluate change in circulating tumor cell (CTC) counts over time in men with metastatic treatment-refractory CRPC in response to temsirolimus therapy.
Timeline
- Start
- 2009-07
- Primary completion
- 2012-08
- Completion
- 2012-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Temsirolimus | Small molecule | 25 mg | Intravenous |
| Background | Diphenhydramine | Unknown | 25 mg | Intravenous |
| Background | Diphenhydramine | Unknown | 50 mg | Intravenous |