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
18 Years
N/A
Male
Prostatic Neoplasms
Trial Information
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
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.
Inclusion 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
Type of Study:
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
Outcome Measure:
Progression-Free Survival (PFS)
Outcome Description:
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.
Outcome Time Frame:
Baseline up to 6 months after last dose of study treatment, assessed up to 551 days
Safety Issue:
No
Principal Investigator
Centocor, Inc. Clinical Trial
Investigator Role:
Study Director
Investigator Affiliation:
Centocor, Inc.
Authority:
United States: Food and Drug Administration
Study ID:
CR013249
NCT ID:
NCT00537381
Start Date:
May 2007
Completion Date:
November 2009
Related Keywords:
- Prostatic Neoplasms
- Prostatic neoplasms
- CNTO 95
- Intetumumab
- Docetaxel
- Prednisone
- Neoplasms
- Prostatic Neoplasms
Name | Location |
|---|---|
| Birmingham, Alabama 35294 | |
| Fountain Valley, California 92708 | |
| Kansas City, Kansas 66160 | |
| Metairie, Louisiana 70006 | |
| Charleston, South Carolina |
