Clinical trial NCT00537381: An Efficacy and Safety Study of Intetumumab (CNTO 95) in Participants With Metastatic Hormone Refractory Prostate Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostatic Neoplasms
Keywords: Prostatic neoplasms
CNTO 95
Intetumumab
Docetaxel
Prednisone
Lead sponsor: Centocor, Inc.
Sponsor class: INDUSTRY
First posted: 2007-10-01
Enrollment: 131
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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
* Have progressive hormone-refractory disease after orchiectomy or gonadotropin-releasing hormone analog and/or antiandrogen treatment within 6 months prior to the first study agent administration 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

Primary outcomes:
measure: Progression-Free Survival (PFS)
timeFrame: Baseline up to 6 months after last dose of study treatment, assessed up to 551 days
Secondary outcomes:
measure: Number of Participants With Best Overall Response (OR)
timeFrame: Baseline up to 6 months after last dose of study treatment, assessed up to 551 days
measure: Number of Participants With Prostate Specific Antigen (PSA) Response
timeFrame: Baseline up to 6 months after last dose of study treatment or early withdrawal, assessed up to 601 days
measure: Overall Survival
timeFrame: Baseline until death (up to 887 days)
measure: Percent Change From Baseline in 'C-telopeptide of Type I Collagen (CTx)' Marker Concentration
timeFrame: Baseline, Week 6, 7, 10 and 13
measure: Percent Change From Baseline in 'N-telopeptide of Type I Collagen (NTx)' Marker Concentration
timeFrame: Baseline, Week 6, 7, 10 and 13
measure: Percent Change From Baseline in 'Vascular Endothelial Growth Factor (VEGF)' Marker Concentration
timeFrame: Baseline, Week 6, 7, 10 and 13
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Los Angeles
country: United States
state: California
city: San Bernardino
country: United States
state: California
city: Wichita
country: United States
state: Kansas
city: Shreveport
country: United States
state: Louisiana
city: Charleston
country: United States
state: South Carolina
city: N Charleston
country: United States
state: South Carolina
city: Graz
country: Austria
city: Wels N/A
country: Austria
city: Wien
country: Austria
city: Antwerpen
country: Belgium
city: Brasschaat
country: Belgium
city: Brussel
country: Belgium
city: Doornik
country: Belgium
city: Haine-Saint-Paul, La Louviere
country: Belgium
city: Leuven
country: Belgium
city: Liÿge
country: Belgium
city: Ottignies
country: Belgium
city: Roeselare
country: Belgium
city: Wilrijk
country: Belgium
city: Aschaffenburg
country: Germany
city: Berlin
country: Germany
city: Freiburg
country: Germany
city: Kirchheim
country: Germany
city: Köln
country: Germany
city: Marburg
country: Germany
city: München
country: Germany
city: Tübingen
country: Germany
city: Ahmedabad
country: India
city: Bangalore
country: India
city: Chennai
country: India
city: Mumbai
country: India
city: New Delhi
country: India
city: Pune
country: India
city: Apeldoorn
country: Netherlands
city: Den Haag
country: Netherlands
city: Leiden
country: Netherlands
city: Maastricht
country: Netherlands
city: Nijmegen
country: Netherlands
city: Bydgoszcz
country: Poland
city: Gdansk
country: Poland
city: Inowroclaw
country: Poland
city: Koscierzyna
country: Poland
city: Lodz
country: Poland
city: Lublin
country: Poland
city: Ekaterinburg
country: Russian Federation
city: Moscow N/A
country: Russian Federation
city: Moscow Region
country: Russian Federation
city: Moscow
country: Russian Federation
city: St Petersburg
country: Russian Federation
city: St-Petersburg Leningrad
country: Russian Federation
city: Voronezh
country: Russian Federation
city: Yaroslavl
country: Russian Federation
city: Johannesburg Gauteng
country: South Africa
city: Pretoria Gauteng
country: South Africa
city: Pretoria
country: South Africa
city: Cambridge
country: United Kingdom
city: Leicester
country: United Kingdom
city: Lincoln
country: United Kingdom
city: London
country: United Kingdom
Study officials:
affiliation: Centocor, Inc.
name: Centocor, Inc. Clinical Trial
role: STUDY_DIRECTOR
References: