Neoadjuvant Therapy With Docetaxel and Ketoconazole in Patients With High-Risk Prostate Cancer: A Pilot Study

NAUnknownINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

September 30, 2004

Primary Completion Date

September 30, 2010

Conditions
Prostate Cancer
Interventions
DRUG

Docetaxel

Docetaxel 55mg/m2 to be given IV as a one-hour infusion to be repeated every 21 days for four treatment cycles.

DRUG

Ketoconazole

Ketoconazole 400mg P.O. BID daily to start on day 2 following the first docetaxel treatment. In patients who experience no grade 2 or higher toxicity, the ketoconazole dose will be increased to 400mg TID on day 2 following cycle #2 of docetaxel. This will be continued daily until completion of study treatment.

Trial Locations (1)

64128

Kansas City VAMC, Kansas City

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Sanofi

INDUSTRY

lead

Kansas City Veteran Affairs Medical Center

FED

NCT00870714 - Neoadjuvant Therapy With Docetaxel and Ketoconazole in Patients With High-Risk Prostate Cancer: A Pilot Study | Biotech Hunter | Biotech Hunter