NCT01206036

CESAR Study in Prostate Cancer With Temsirolimus Added to Standard Docetaxel Therapy (CEPTAS)

Phase I/II Study With Temsirolimus Versus no add-on in Patients With Castration Resistant Prostate Cancer (CRPC) Receiving First-line Docetaxel Chemotherapy

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Central European Society for Anticancer Drug Research · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

In this Phase I study safety of the combination of Docetaxel and Temsirolimus needs to be shown before the study can be expanded into a Phase II study to examine the activity of a safe combination of Temsirolimus and Docetaxel in a comparison with Docetaxel alone.

Detailed description

The purpose of this Phase I study is to evaluate feasibility of dose levels DL1, DL2 and DL3 (which are combinations of Temsirolimus and Docetaxel) and defining a recommended dose (RD) for the Phase II part using these dose levels in a dose escalating scheme. Secondary objectives are the collection of safety data on the dose levels used in this part.

Conditions

• Prostatic Neoplasms

Interventions

Type	Name	Description
DRUG	Docetaxel	DL 1: Docetaxel 60mg/m\^2, Temsirolimus 15mg. DL 2: Docetaxel 60mg/m\^2, Temsirolimus 25mg. DL 3: Docetaxel 75mg/m\^2, Temsirolimus 25mg. One cycle is defined as a 3 week period (21 days) where docetaxel is given on day 1, and temsirolimus on days 1, 8 and 15.
DRUG	Temsirolimus	DL 1: Docetaxel 60mg/m\^2, Temsirolimus 15mg. DL 2: Docetaxel 60mg/m\^2, Temsirolimus 25mg. DL 3: Docetaxel 75mg/m\^2, Temsirolimus 25mg. One cycle is defined as a 3 week period (21 days) where docetaxel is given on day 1, and temsirolimus on days 1, 8 and 15.

Timeline

• Start date: 2010-07-01
• Primary completion: 2014-09-01
• Completion: 2015-10-01
• First posted: 2010-09-21
• Last updated: 2016-01-27

Locations

2 sites across 1 country: Germany