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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00537381
Recruitment Status : Completed
First Posted : October 1, 2007
Results First Posted : May 20, 2013
Last Update Posted : June 20, 2013
Sponsor:
Information provided by (Responsible Party):
Centocor, Inc.

Tracking Information
First Submitted Date  ICMJE September 27, 2007
First Posted Date  ICMJE October 1, 2007
Results First Submitted Date  ICMJE March 28, 2013
Results First Posted Date  ICMJE May 20, 2013
Last Update Posted Date June 20, 2013
Study Start Date  ICMJE May 2007
Actual Primary Completion Date November 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 12, 2013)
Progression-Free Survival (PFS) [ Time Frame: Baseline up to 6 months after last dose of study treatment, assessed up to 551 days ]
The PFS was assessed as median number of days from baseline until the first documented sign of disease progression (increase in disease; radiographic, clinical, or both) or death due to any cause, whichever occurred earlier.
Original Primary Outcome Measures  ICMJE
 (submitted: September 27, 2007)
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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 12, 2013)
  • Number of Participants With Best Overall Response (OR) [ Time Frame: Baseline up to 6 months after last dose of study treatment, assessed up to 551 days ]
    Number of participants with best OR is based on assessment of confirmed complete response (CR) or confirmed partial response (PR). Confirmed CR is defined as disappearance of all target lesions. Confirmed PR is defined as greater than or equal to 30 percent decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD. Confirmed responses are those that persist on repeat imaging study greater than or equal to 4 weeks after initial documentation of response.
  • Number of Participants With Prostate Specific Antigen (PSA) Response [ Time Frame: Baseline up to 6 months after last dose of study treatment or early withdrawal, assessed up to 601 days ]
    The PSA response is defined as at least a 50 percent decrease in PSA below the baseline value, confirmed by a second PSA value greater than or equal to 6 weeks later. A participant was considered to be a PSA responder if and only if the response occurs prior to PSA progression (increase of at least 25 percent and an increase of 5 nanogram per milliliter from the lowest observed PSA value since initiation of treatment, to be confirmed greater than or equal to 3 weeks later).
  • Overall Survival [ Time Frame: Baseline until death (up to 887 days) ]
    Overall Survival is defined as the time from the date of randomization to death due to any cause. For participants who were alive at the time of analysis, overall survival was censored at the last contact date.
  • Percent Change From Baseline in 'C-telopeptide of Type I Collagen (CTx)' Marker Concentration [ Time Frame: Baseline, Week 6, 7, 10 and 13 ]
    Percent change = marker concentration at time of measurement minus baseline value divided by baseline value multiplied by 100.
  • Percent Change From Baseline in 'N-telopeptide of Type I Collagen (NTx)' Marker Concentration [ Time Frame: Baseline, Week 6, 7, 10 and 13 ]
    Percent change = marker concentration at time of measurement minus baseline value divided by baseline value multiplied by 100.
  • Percent Change From Baseline in 'Vascular Endothelial Growth Factor (VEGF)' Marker Concentration [ Time Frame: Baseline, Week 6, 7, 10 and 13 ]
    Percent change = marker concentration at time of measurement minus baseline value divided by baseline value multiplied by 100.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 27, 2007)
  • Tumor and PSA response rate
  • Overall survival;Change from baseline in ECOG (Eastern Cooperative Oncology Group) performance status; PK CNTO 95; Serum concentrations of CNTO 95 over time;Incidence of Adverse Events (AEs) throughout the course of the trial.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An Efficacy and Safety Study of Intetumumab (CNTO 95) in Participants With Metastatic Hormone Refractory Prostate Cancer
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Prostatic Neoplasms
Intervention  ICMJE
  • Drug: Docetaxel
    Docetaxel 75 mg/m^2 as intravenous infusion every 3 weeks.
  • Drug: Prednisone
    Prednisone 5 mg orally twice daily.
  • Biological: Intetumumab
    Intetumumab 10 mg/kg as intravenous infusion every week for initial 6 weeks, then every 3 weeks.
    Other Name: CNTO 95
  • Drug: Placebo
    Placebo matching to intetumumab, as intravenous infusion every week for initial 6 weeks, then every 3 weeks.
Study Arms  ICMJE
  • Active Comparator: 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.
    Interventions:
    • Drug: Docetaxel
    • Drug: Prednisone
    • Drug: Placebo
  • Experimental: 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.
    Interventions:
    • Drug: Docetaxel
    • Drug: Prednisone
    • Biological: Intetumumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 25, 2009)
131
Original Enrollment  ICMJE
 (submitted: September 27, 2007)
120
Actual Study Completion Date  ICMJE November 2009
Actual Primary Completion Date November 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria,   Belgium,   Germany,   India,   Netherlands,   Poland,   Russian Federation,   South Africa,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00537381
Other Study ID Numbers  ICMJE CR013249
C1034T08 ( Other Identifier: Centocor, Inc. )
2006-005766-39 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Centocor, Inc.
Study Sponsor  ICMJE Centocor, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Centocor, Inc. Clinical Trial Centocor, Inc.
PRS Account Centocor, Inc.
Verification Date June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP