Safety and Efficacy Study of GM-CSF, Thalidomide Plus Docetaxel in Prostate Cancer

PHASE2TerminatedINTERVENTIONAL
Enrollment

9

Participants

Timeline

Start Date

December 31, 2006

Primary Completion Date

August 31, 2008

Study Completion Date

September 30, 2008

Conditions
Prostatic Neoplasms
Interventions
DRUG

GM-CSF

fixed dose of 250 mcg/m2, 3 days per week by subcutaneous injection

DRUG

thalidomide

Thalidomide by oral administration at a fixed dose of 200 mg. Prophylactic Coumadin® by oral administration at a fixed dose of 2.5 mg to prevent thromboembolic events (DVT and TIA/stroke) during Thalidomide administration. Thalidomide and Coumadin will be given daily at bedtime without interruption.

DRUG

docetaxel

Docetaxel will be administered by intravenous piggyback over 1 hour at 75mg/m² every 3 weeks. Pre-medication for the docetaxel infusion will consist of dexamethasone 8 mg administered orally 12 hours, 3 hours and 1 hour before docetaxel.

Trial Locations (1)

77030

The Methodist Hospital Research Institute, Houston

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Bayer

INDUSTRY

lead

The Methodist Hospital Research Institute

OTHER