An Efficacy and Safety Study of Intetumumab (CNTO 95) in Participants With Metastatic Hormone Refractory Prostate Cancer
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| ClinicalTrials.gov Identifier: NCT00537381 |
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Recruitment Status :
Completed
First Posted : October 1, 2007
Results First Posted : May 20, 2013
Last Update Posted : June 20, 2013
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Sponsor:
Centocor, Inc.
Information provided by (Responsible Party):
Centocor, Inc.
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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).
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Prostatic Neoplasms | Drug: Docetaxel Drug: Prednisone Biological: Intetumumab Drug: Placebo | Phase 2 |
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 : | Interventional (Clinical Trial) |
| Actual Enrollment : | 131 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, 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 |
| Study Start Date : | May 2007 |
| Actual Primary Completion Date : | November 2009 |
| Actual Study Completion Date : | November 2009 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Prostate cancer
| Arm | Intervention/treatment |
|---|---|
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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.
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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. |
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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.
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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 |
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 ]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 ]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.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00537381
Locations
Show 60 study locations
Sponsors and Collaborators
Centocor, Inc.
Investigators
| Study Director: | Centocor, Inc. Clinical Trial | Centocor, Inc. |
| Responsible Party: | Centocor, Inc. |
| ClinicalTrials.gov Identifier: | NCT00537381 |
| Other Study ID Numbers: |
CR013249 C1034T08 ( Other Identifier: Centocor, Inc. ) 2006-005766-39 ( EudraCT Number ) |
| First Posted: | October 1, 2007 Key Record Dates |
| Results First Posted: | May 20, 2013 |
| Last Update Posted: | June 20, 2013 |
| Last Verified: | June 2013 |
Keywords provided by Centocor, Inc.:
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Prostatic neoplasms CNTO 95 Intetumumab Docetaxel Prednisone |
Additional relevant MeSH terms:
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Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Prostatic Diseases Prednisone Docetaxel Intetumumab Antineoplastic Agents Tubulin Modulators |
Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Anti-Inflammatory Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Antineoplastic Agents, Hormonal Antineoplastic Agents, Immunological |