A Study of CNTO 328 in Patients With Metastatic Hormone-Refractory Prostate Cancer

• Status: Completed
• Trial end date: 2009-11-01
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of this study is to determine the safety of docetaxel and CNTO 328 when given together as a treatment. The second goal of this study is to determine if a combination of docetaxel and CNTO 328 has an effect on prostate cancer.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centocor, Inc.
• Treatments: Antibodies, Monoclonal; Docetaxel; Hormones; Siltuximab

Criteria

Inclusion Criteria:

• Histologically or cytologically confirmed adenocarcinoma of the prostate

• Radiologically documented metastatic disease

• No prior systemic chemotherapy for metastatic hormone refractory prostate cancer

• Progressive hormone-refractory disease after orchiectomy or gonadotropin-releasing hormone analog and/or anti-androgen treatment within 12 months of screening based on 1 of the following: Transaxial imaging tumor progression, Rise in 2 consecutive prostate-specifec antigen (PSA) values obtained at least 7 days apart or Radionucleotide bone scan progression

• Karnofsky performance status of greater than or equal to 60

Exclusion Criteria:

• Prostate cancer that does not express serum PSA or is less than 5.0 ng/mL at screening

• Received any investigational drug/agent within 30 days or 5 half-lives, whichever is longer

• Prior malignancy (other than prostate cancer) except adequately treated basal cell or squamous cell carcinoma of the skin or other cancer for which the subject has been disease-free for greater than or equal to 3 years

• Known central nervous system metastases

• Received any over-the-counter or herbal treatment for prostate cancer (eg, PC SPES [an herbal refined powder]) within 4 weeks prior to screening.