An Efficacy and Safety Study of Intetumumab (CNTO 95) in Participants With Metastatic Hormone Refractory Prostate Cancer

Completed · Phase 2 · Has a placebo group

Conditions studied: Prostatic Neoplasms

In brief

The purpose of this study is to assess the effects of intetumumab when given in combination with docetaxel and prednisone to participants with metastatic (spread of cancer cells from one part of the body to another) hormone-refractory (not responding to treatment) prostate cancer (abnormal tissue that grows and spreads in the body until it kills).

Key facts

Study ID

NCT00537381

Run by

Centocor, Inc.

People needed

131

Starts

2007-05-01

Expected to finish

2009-11-01

Last updated by the study team

2013-06-20

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• Study site — Los Angeles, California, United States
• Study site — San Bernardino, California, United States
• Study site — Wichita, Kansas, United States
• Study site — Shreveport, Louisiana, United States
• Study site — Charleston, South Carolina, United States
• Study site — North Charleston, South Carolina, United States
• Study site — Graz, Austria
• Study site — Vienna, Austria
• Study site — Wels, Austria
• Study site — Antwerp, Belgium
• Study site — Brasschaat, Belgium
• Study site — Brussels, Belgium
• Study site — Haine-Saint-Paul, La Louviere, Belgium
• Study site — Leuven, Belgium
• Study site — Liÿge, Belgium
• Study site — Ottignies, Belgium
• Study site — Roeselare, Belgium
• Study site — Tournai, Belgium
• Study site — Wilrijk, Belgium
• Study site — Aschaffenburg, Germany
• Study site — Berlin, Germany
• Study site — Cologne, Germany
• Study site — Freiburg im Breisgau, Germany
• Study site — Kirchheim, Germany
• Study site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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