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

This study has been completed.
Sponsor:
Information provided by:
Centocor, Inc.
ClinicalTrials.gov Identifier:
NCT00401765
First received: November 17, 2006
Last updated: April 7, 2011
Last verified: April 2011
  Purpose

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.


Condition Intervention Phase
Prostatic Neoplasms
Drug: CNTO 328
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Study of a Chimeric Antibody Against Interleukin-6 (CNTO 328) Combined With Docetaxel in Subjects With Metastatic Hormone-Refractory Prostate Cancer

Resource links provided by NLM:


Further study details as provided by Centocor, Inc.:

Primary Outcome Measures:
  • Assess the safety and tolerability of multiple dosing regimens of CNTO328 when administered in combination with docetaxel each cycle. The pharmacokinetics of docetaxel when administered alone and in combination with CNTO328 will be assessed.

Secondary Outcome Measures:
  • To evaluate efficacy and pharmacodynamics of CNTO328 administered in combination with docetaxel each cycle. In a limited number of patients, the pharmacokinetics of CNTO328 alone and in combination with docetaxel will also be evaluated.

Enrollment: 40
Study Start Date: October 2005
Study Completion Date: November 2009
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically or cytologically confirmed adenocarcinoma of the prostate
  • Radiologically documented metastatic disease
  • No prior systemic chemotherapy for metastatic HRPC
  • 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 PSA values obtained at least 7 days apart or Radionucleotide bone scan progression
  • Karnofsky performance status of >=60

Exclusion Criteria:

  • Prostate cancer that does not express serum PSA or is < 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 >= 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00401765

Sponsors and Collaborators
Centocor, Inc.
Investigators
Study Director: Centocor, Inc. Clinical Trial Centocor, Inc.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00401765     History of Changes
Other Study ID Numbers: CR005275
Study First Received: November 17, 2006
Last Updated: April 7, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Centocor, Inc.:
Prostatic neoplasm
intravenous
docetaxel
monoclonal antibody

Additional relevant MeSH terms:
Neoplasms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on April 17, 2014