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

NCT ID: NCT00537381

Last Updated: 2013-06-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 131 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-05-31
• Study Completion Date: 2009-11-30

Brief Summary

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).

Detailed Description

This is a multicenter (when more than one hospital or medical school team work on a medical research study), randomized (the study drug is assigned by chance), double-blind (neither physician nor participant knows the treatment that the participant receives) study of intetumumab in combination with docetaxel and prednisone for the first-line treatment of participants with metastatic hormone-refractory prostate cancer. There will be 2 study groups. One group will receive intetumumab in combination with docetaxel and prednisone (study treatment) and the other group will receive placebo (an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial) matching to intetumumab in combination with docetaxel and prednisone (control treatment). The duration of treatment will be 6 months. Participants who respond to treatment with stable disease or better will receive extended treatment until disease progression (disease worsening) or for an additional 6 months, whichever occurs first. Treatment can be further continued with the sponsor's discretion after receiving 6 months of extended treatment, if participant response to the treatment (with stable disease, partial response, or complete response). Participants who have confirmed progressive disease while receiving study treatment may have their treatment unblinded (participants will know the name of drug which was given to them), if they wish to be considered for alternative treatment. Participants who were receiving the control treatment will be considered to have completed the study treatment, and will have the option to receive alternative treatment. Alternative treatment will either be intetumumab along with docetaxel and prednisone or intetumumab alone. Participants' safety will be monitored throughout the study.

Conditions

Prostatic Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Docetaxel + Prednisone + Placebo

Matching placebo as intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) every week for initial 6 weeks, then every 3 weeks; along with docetaxel 75 milligram per square meter (mg/m\^2) as intravenous infusion every 3 weeks and prednisone 5 mg orally twice daily were administered till 6 months or disease progression.

Group Type: ACTIVE_COMPARATOR

Docetaxel

Intervention Type: DRUG

Docetaxel 75 mg/m\^2 as intravenous infusion every 3 weeks.

Prednisone

Intervention Type: DRUG

Prednisone 5 mg orally twice daily.

Placebo

Intervention Type: DRUG

Placebo matching to intetumumab, as intravenous infusion every week for initial 6 weeks, then every 3 weeks.

Docetaxel + Prednisone + Intetumumab

Intetumumab 10 mg per kilogram (mg/kg) as intravenous infusion every week for initial 6 weeks, then every 3 weeks; along with docetaxel 75 mg/m\^2 as intravenous infusion every 3 weeks and prednisone 5 mg orally twice daily were administered till 6 months or disease progression.

Group Type: EXPERIMENTAL

Docetaxel

Intervention Type: DRUG

Docetaxel 75 mg/m\^2 as intravenous infusion every 3 weeks.

Prednisone

Intervention Type: DRUG

Prednisone 5 mg orally twice daily.

Intetumumab

Intervention Type: BIOLOGICAL

Intetumumab 10 mg/kg as intravenous infusion every week for initial 6 weeks, then every 3 weeks.

Interventions

Docetaxel

Docetaxel 75 mg/m\^2 as intravenous infusion every 3 weeks.

Intervention Type: DRUG

Prednisone

Prednisone 5 mg orally twice daily.

Intervention Type: DRUG

Intetumumab

Intetumumab 10 mg/kg as intravenous infusion every week for initial 6 weeks, then every 3 weeks.

Intervention Type: BIOLOGICAL

Placebo

Placebo matching to intetumumab, as intravenous infusion every week for initial 6 weeks, then every 3 weeks.

Intervention Type: DRUG

Other Intervention Names

CNTO 95

Eligibility Criteria

Inclusion Criteria

• 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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Centocor, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Centocor, Inc. Clinical Trial

Role: STUDY_DIRECTOR

Centocor, Inc.

Locations

Birmingham, Alabama, United States

Los Angeles, California, United States

San Bernardino, California, United States

Wichita, Kansas, United States

Shreveport, Louisiana, United States

Charleston, South Carolina, United States

North Charleston, South Carolina, United States

Graz, , Austria

Vienna, , Austria

Wels, , Austria

Antwerp, , Belgium

Brasschaat, , Belgium

Brussels, , Belgium

Haine-Saint-Paul, La Louviere, , Belgium

Leuven, , Belgium

Liÿge, , Belgium

Ottignies, , Belgium

Roeselare, , Belgium

Tournai, , Belgium

Wilrijk, , Belgium

Aschaffenburg, , Germany

Berlin, , Germany

Cologne, , Germany

Freiburg im Breisgau, , Germany

Kirchheim, , Germany

Marburg, , Germany

München, , Germany

Tübingen, , Germany

Ahmedabad, , India

Bangalore, , India

Chennai, , India

Mumbai, , India

New Delhi, , India

Pune, , India

Apeldoorn, , Netherlands

Leiden, , Netherlands

Maastricht, , Netherlands

Nijmegen, , Netherlands

The Hague, , Netherlands

Bydgoszcz, , Poland

Gdansk, , Poland

Inowrocław, , Poland

Kościerzyna, , Poland

Lodz, , Poland

Lublin, , Poland

Moscow, , Russia

Moscow Region, , Russia

Saint Petersburg, , Russia

St-Petersburg Leningrad, , Russia

Voronezh, , Russia

Yaroslavl, , Russia

Yekaterinburg, , Russia

Johannesburg Gauteng, , South Africa

Pretoria, , South Africa

Pretoria Gauteng, , South Africa

Cambridge, , United Kingdom

Leicester, , United Kingdom

Lincoln, , United Kingdom

London, , United Kingdom

Countries

United States; Austria; Belgium; Germany; India; Netherlands; Poland; Russia; South Africa; United Kingdom

Other Identifiers

C1034T08

Identifier Type: OTHER

Identifier Source: secondary_id

2006-005766-39

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CR013249

Identifier Type: -

Identifier Source: org_study_id