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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Centocor, Inc.
ClinicalTrials.gov Identifier:
NCT00537381
First received: September 27, 2007
Last updated: June 12, 2013
Last verified: June 2013
  Purpose

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).


Condition Intervention Phase
Prostatic Neoplasms
Drug: Docetaxel
Drug: Prednisone
Biological: Intetumumab
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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) [ Time Frame: Baseline up to 6 months after last dose of study treatment, assessed up to 551 days ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Percent change = marker concentration at time of measurement minus baseline value divided by baseline value multiplied by 100.


Enrollment: 131
Study Start Date: May 2007
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: Docetaxel
Docetaxel 75 mg/m^2 as intravenous infusion every 3 weeks.
Drug: Prednisone
Prednisone 5 mg orally twice daily.
Drug: Placebo
Placebo matching to intetumumab, as intravenous infusion every week for initial 6 weeks, then every 3 weeks.
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.
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00537381

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

No publications provided

Responsible Party: Centocor, Inc.
ClinicalTrials.gov Identifier: NCT00537381     History of Changes
Other Study ID Numbers: CR013249, C1034T08, 2006-005766-39
Study First Received: September 27, 2007
Results First Received: March 28, 2013
Last Updated: June 12, 2013
Health Authority: United States: Food and Drug Administration
United States: Federal Government

Keywords provided by Centocor, Inc.:
Prostatic neoplasms
CNTO 95
Intetumumab
Docetaxel
Prednisone

Additional relevant MeSH terms:
Neoplasms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Antibodies, Monoclonal
Prednisone
Docetaxel
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 21, 2014