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

This study is currently recruiting participants.

Verified by Centocor, Inc., April 2009

First Received: November 17, 2006 Last Updated: April 30, 2009 History of Changes

Sponsored by:	Centocor, Inc.
Information provided by:	Centocor, Inc.
ClinicalTrials.gov Identifier:	NCT00401765

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 I

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Docetaxel

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
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

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.

Estimated Enrollment:	36
Study Start Date:	September 2005

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

Contacts

Contact: Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions:

info1@veritasmedicine.com

Locations

United States, Maryland
	Recruiting
Baltimore, Maryland, United States, 21205
United States, New York
	Recruiting
New York, New York, United States, 10021
United States, North Carolina
	Recruiting
Chapel Hill, North Carolina, United States, 27599
United States, Pennsylvania
	Active, not recruiting
Philadelphia, Pennsylvania, United States, 19104
	Recruiting
Philadelphia, Pennsylvania, United States, 19111
United States, Tennessee
	Active, not recruiting
Nashville, Tennessee, United States, 37232

Sponsors and Collaborators

Centocor, Inc.

Investigators

Study Director:

Centocor, Inc. Clinical Trial

Centocor, Inc.

More Information

Additional Information:

To learn how to participate in this trial please click here. This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CR005275
Study First Received:	November 17, 2006
Last Updated:	April 30, 2009
ClinicalTrials.gov Identifier:	NCT00401765 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Centocor, Inc.:

monoclonal antibody
intravenous
docetaxel
Prostatic neoplasm

Study placed in the following topic categories:

Antibodies, Monoclonal
Docetaxel
Antibodies
Prostatic Diseases
Genital Neoplasms, Male

Urogenital Neoplasms
Genital Diseases, Male
Hormones
Prostatic Neoplasms
Immunoglobulins

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Prostatic Diseases
Genital Neoplasms, Male

Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

ClinicalTrials.gov processed this record on May 06, 2009