drugset / Trial / NCT00887640

Impact of Temsirolimus Therapy on Circulating Tumor Cell Biology In Men With Castration Resistant Metastatic Prostate Cancer

NCT00887640

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

EvaluationDrugModalityDoseRoute
Subject Temsirolimus Small molecule 25 mg Intravenous
Background Diphenhydramine Unknown 25 mg Intravenous
Background Diphenhydramine Unknown 50 mg Intravenous

Indications