Study of Abraxane Plus Hormonal Therapy as Initial Treatment of Unresectable or Metastatic Prostate Cancer

PHASE2TerminatedINTERVENTIONAL
Enrollment

14

Participants

Timeline

Start Date

August 31, 2007

Primary Completion Date

September 30, 2008

Study Completion Date

October 31, 2008

Conditions
Prostatic Neoplasms
Interventions
DRUG

Abraxane

100 mg/m2 IVPB Day 1, 8, 15, 22, 29,36,43,50 of each cycle for 4 nine-week cycles (Each cycle of Abraxane/hormonal therapy will consist of 8 weeks of Abraxane therapy and 1 week of rest.)

DRUG

Leuprolide

7.5 mg monthly or 22.5 mg quarterly, can begin within 3 months of initiating Abraxane for 2 years

DRUG

Bicalutamide

50 mg p.o. daily starts week 36 of initiating Abraxane.

Trial Locations (1)

77030

Baylor College of Medicine - Methodist Hospital, Houston

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Celgene Corporation

INDUSTRY

lead

The Methodist Hospital Research Institute

OTHER