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A Study of the Safety and Effectiveness of CNTO 95 in Patients Wih Metastatic Hormone Refractory Prostate Cancer
This study is ongoing, but not recruiting participants.
First Received: September 27, 2007   Last Updated: November 20, 2008   History of Changes
Sponsored by: Centocor, Inc.
Information provided by: Centocor, Inc.
ClinicalTrials.gov Identifier: NCT00537381
  Purpose

The purpose of this study is to assess the effects (good and bad) of CNTO 95 when given in combination with docetaxel and prednisone to patients with metastatic hormone refractory prostate cancer (HRPC).


Condition Intervention Phase
Prostate Cancer
Drug: Placebo, docetaxel, prednisone
Biological: CNTO 95, docetaxel, prednisone
Phase II

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Centocor, Inc.:

Primary Outcome Measures:
  • Progression-free survival (PFS), defined as the time from the date of randomization until the first documented sign of disease progression or death throughout the course of the trial. [ Time Frame: Progression free survival throughout the course of the trial ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Tumor and PSA response rate [ Time Frame: Biomarkers, quality of life, pharmacokinetics throughout the course of the trial ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: April 2007
Estimated Study Completion Date: November 2009
Arms Assigned Interventions
001: Placebo Comparator Drug: Placebo, docetaxel, prednisone
Placebo infusions once a week for first 7 weeks then every 3 weeks until week 76; docetaxel - infusion of 75mg/kg every 3 wks through wk 76; prednisone - 5mg oral two times a day
002: Experimental Biological: CNTO 95, docetaxel, prednisone
Infusion of 10 mg/kg once a wk for first 7 wks then every 3 wks through wk 76; docetaxel - infusion of 75mg/kg every 3 wks through wk 76; prednisone - 5mg oral two times a day

Detailed Description:

CNTO 95 is an antibody. Antibodies are substances in the body that fight infection. CNTO 95 is thought to work by blocking substances on cells called integrins that are involved in formation of new blood vessels (angiogenesis).

More specifically, cancer drugs like CNTO 95, work by preventing the formation of blood vessels that feed tumors.

These types of cancer drugs are called anti-angiogenic drugs. When new blood vessels are stopped from being made, cancer tumors cannot get the food and oxygen they need to grow. As a result anti-angiogenic drugs may stop cancer tumors from growing and spreading. In this study the combination of CNTO 95 with docetaxel and prednisone will be tested to see if it is safe and to see what effects it has on cancer. Docetaxel and prednisone are approved chemotherapy (cancer drug) for Hormone Refractory Prostate Cancer (HRPC). If eligible to take part in this study, the patient will be randomly placed into one of two study groups. The study is "blinded". This means that neither the patient nor the study doctor will know which group the patient is placed. The patient will have an equal chance of being put in either group. There will be 2 study groups. In Group 1, patients will receive docetaxel (75 mg/m2) and prednisone plus placebo. In Group 2, patients will receive docetaxel (75 mg/m2) and prednisone plus CNTO 95 (10 mg/kg). Placebo is an inactive or dummy treatment that looks the same as CNTO 95, but does not contain any active medication. Placebo (group 1) / CNTO 95 (group 2) and docetaxel are given through a small tube that goes directly into your vein; this is called an intravenous (IV) infusion. The infusion of docetaxel (75 mg/ m2) will be given every 3 weeks. Placebo/CNTO 95 will be given weekly for the first 7 weeks and every three weeks thereafter. If the patient's cancer gets worse, both the patient and the study doctor will be able to find out what group the patient was placed in. If the patient was placed in Group 1, and received placebo, the patient will be given the option to continue in the study and receive CNTO 95 (10mg/kg) rather than placebo. Safety and effectiveness evaluations will be performed at specified intervals throughout the study and will consist of assessment of laboratory tests, vital signs (such as blood pressure), physical examinations and collection of information about the occurrence and severity of adverse events. Patient participation in the study will last up to 76 weeks.

An infusion (into the vein) of placebo or CNTO 95 will be given once a week for the first 7 weeks and every three weeks thereafter. An infusion (into the vein) of docetaxel (75 mg/m2 will be given every 3 weeks and prednisone tablets twice a day for up to one year.

  Eligibility

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

Inclusion Criteria:

  • Confirmed adenocarcinoma of the prostate
  • Evidence of metastatic disease
  • Have a life expectancy > 12 weeks

Exclusion Criteria:

  • Have known Central Nervous System (CNS) metastases
  • Had prior systemic nonhormonal therapy for HRPC
  • Have known HIV seropositivity or known hepatitis B or C infection
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00537381

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

No publications provided

Responsible Party: Centocor Inc. ( Director Clinical Research )
Study ID Numbers: CR013249, C1034T08
Study First Received: September 27, 2007
Last Updated: November 20, 2008
ClinicalTrials.gov Identifier: NCT00537381     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Centocor, Inc.:
Docetaxel
CNTO 95
Prednisone
prostate cancer
infusion

Study placed in the following topic categories:
Anti-Inflammatory Agents
Prednisone
Antineoplastic Agents, Hormonal
Genital Neoplasms, Male
Prostatic Diseases
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Urogenital Neoplasms
Genital Diseases, Male
Hormones
Glucocorticoids
Docetaxel
Antibodies, Monoclonal
Antibodies
Prostatic Neoplasms
Immunoglobulins

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Prednisone
Antineoplastic Agents, Hormonal
Genital Neoplasms, Male
Prostatic Diseases
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Urogenital Neoplasms
Genital Diseases, Male
Glucocorticoids
Hormones
Pharmacologic Actions
Docetaxel
Neoplasms
Neoplasms by Site
Therapeutic Uses
Prostatic Neoplasms

ClinicalTrials.gov processed this record on September 11, 2009