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

Prostatic Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00537381
• Other study ID #: CR013249
• Secondary ID: C1034T082006-005
• Status: Completed
• Phase: Phase 2
• First received: September 27, 2007
• Last updated: June 12, 2013
• Start date: May 2007
• Est. completion date: November 2009

Study information

• Verified date: June 2013
• Source: Centocor, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Federal Government
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 131
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostatic Neoplasms

Intervention

Drug:
• Docetaxel
Docetaxel 75 mg/m^2 as intravenous infusion every 3 weeks.
• 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.

Drug:
• Placebo
Placebo matching to intetumumab, as intravenous infusion every week for initial 6 weeks, then every 3 weeks.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centocor, Inc.

Countries where clinical trial is conducted

United States,  Austria,  Belgium,  Germany,  India,  Netherlands,  Poland,  Russian Federation,  South Africa,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline up to 6 months after last dose of study treatment, assessed up to 551 days	No
Secondary	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.	Baseline up to 6 months after last dose of study treatment, assessed up to 551 days	No
Secondary	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).	Baseline up to 6 months after last dose of study treatment or early withdrawal, assessed up to 601 days	No
Secondary	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.	Baseline until death (up to 887 days)	No
Secondary	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.	Baseline, Week 6, 7, 10 and 13	No
Secondary	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.	Baseline, Week 6, 7, 10 and 13	No
Secondary	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.	Baseline, Week 6, 7, 10 and 13	No