Overview

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

Status:
Terminated

Trial end date:
2012-08-01

Target enrollment:

Participant gender:

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.

Phase:

Phase 2

Details

Lead Sponsor:

Duke University

Collaborator:

National Comprehensive Cancer Network

Treatments:

Diphenhydramine
Everolimus
Promethazine
Sirolimus