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).
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
131
Docetaxel 75 mg/m\^2 as intravenous infusion every 3 weeks.
Prednisone 5 mg orally twice daily.
Intetumumab 10 mg/kg as intravenous infusion every week for initial 6 weeks, then every 3 weeks.
Progression-Free Survival (PFS)
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.
Time frame: Baseline up to 6 months after last dose of study treatment, assessed up to 551 days
Number of Participants With Best Overall Response (OR)
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.
Time frame: Baseline up to 6 months after last dose of study treatment, assessed up to 551 days
Number of Participants With Prostate Specific Antigen (PSA) Response
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).
Time frame: Baseline up to 6 months after last dose of study treatment or early withdrawal, assessed up to 601 days
Overall Survival
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.
Time frame: Baseline until death (up to 887 days)
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Placebo matching to intetumumab, as intravenous infusion every week for initial 6 weeks, then every 3 weeks.
Unnamed facility
Birmingham, Alabama, United States
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Los Angeles, California, United States
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San Bernardino, California, United States
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Wichita, Kansas, United States
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Shreveport, Louisiana, United States
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Charleston, South Carolina, United States
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North Charleston, South Carolina, United States
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Graz, Austria
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Vienna, Austria
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Wels, Austria
...and 49 more locations
Percent Change From Baseline in 'C-telopeptide of Type I Collagen (CTx)' Marker Concentration
Percent change = marker concentration at time of measurement minus baseline value divided by baseline value multiplied by 100.
Time frame: Baseline, Week 6, 7, 10 and 13
Percent Change From Baseline in 'N-telopeptide of Type I Collagen (NTx)' Marker Concentration
Percent change = marker concentration at time of measurement minus baseline value divided by baseline value multiplied by 100.
Time frame: Baseline, Week 6, 7, 10 and 13
Percent Change From Baseline in 'Vascular Endothelial Growth Factor (VEGF)' Marker Concentration
Percent change = marker concentration at time of measurement minus baseline value divided by baseline value multiplied by 100.
Time frame: Baseline, Week 6, 7, 10 and 13