A Randomized, Double-blind, Multicenter, Phase 2 Study of a Human Monoclonal Antibody to Human av Integrins (CNTO 95) in Combination With Docetaxel for the First-Line Treatment of Subjects With Metastatic Hormone Refractory Prostate Cancer
- Conditions
- Prostatic NeoplasmsC61Malignant neoplasm of prostate
- Registration Number
- DRKS00003882
- Lead Sponsor
- Centocor, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Male
- Target Recruitment
- 131
Inclusion Criteria
- Confirmed cancer of the prostate
- Evidence of metastatic disease
- Have a life expectancy greater than 12 weeks
- Have at least 4 weeks from previous major surgery to date of first study agent given
- Have progressive hormone-refractory disease after orchiectomy or
gonadotropin-releasing hormone analog and/or antiandrogen treatment within 6 months
prior to the first study agent administration
Exclusion Criteria
- Have known Central Nervous System metastases (cancerous tumors that have spread to
the brain from somewhere else in the body)
- Had prior systemic non-hormonal therapy for hormone refractory prostate cancer
- Have known Human Immunodeficiency Virus (HIV, a life-threatening infection which you
can get from an infected person's blood or from having sex with an infected person)
seropositivity or known hepatitis B or C infection
- Have planned major surgery during the study
- Have taken any over-the-counter (medicine that can be bought without a prescription)
or herbal treatment for prostate cancer within 4 weeks prior to the first study
treatment administration
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method - Progression-Free Survival (PFS); time frame: Baseline up to 6 months after last dose of study treatment, assessed up to 551 days; The PFS was assessed as median number of days from baseline until the first documented sign of disease progression (increase in disease; radiographic, clinical, or both) or death due to any cause, whichever occurred earlier.<br>
- Secondary Outcome Measures
Name Time Method