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Prostatic NeoplasmsPhase 2NCT00537381

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

A Phase 2 study testing Docetaxel, Prednisone and Intetumumab in people with Prostatic Neoplasms, run by Centocor, Inc. at 59 sites in 10 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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… Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostatic Neoplasms
What is being tested?
Docetaxel, Prednisone and Intetumumab
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
131 participants
Where
59 sitesin 10 countries
Study dates
May 2007to Nov 2009
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
Show all 10Show fewer
  • 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

Who cannot join

None listed.

Trial locations and contacts

59 sites in 10 countries.

59 sites in 10 countries

Belgium10 sites

  • Study site

    Antwerp

  • Study site

    Brasschaat

  • Study site

    Brussels

  • Study site

    Haine-Saint-Paul, La Louviere

  • Study site

    Leuven

  • Study site

    Liÿge

  • Study site

    Ottignies

  • Study site

    Roeselare

  • Study site

    Tournai

  • Study site

    Wilrijk

Other trials in Belgium

Germany8 sites

  • Study site

    Aschaffenburg

  • Study site

    Berlin

  • Study site

    Cologne

  • Study site

    Freiburg im Breisgau

  • Study site

    Kirchheim

  • Study site

    Marburg

  • Study site

    München

  • Study site

    Tübingen

Other trials in Germany

United States7 sites

  • Study site

    Birmingham, Alabama

  • Study site

    Charleston, South Carolina

  • Study site

    Los Angeles, California

  • Study site

    North Charleston, South Carolina

  • Study site

    San Bernardino, California

  • Study site

    Shreveport, Louisiana

  • Study site

    Wichita, Kansas

Other trials in United States

Russia7 sites

  • Study site

    Moscow

  • Study site

    Moscow Region

  • Study site

    Saint Petersburg

  • Study site

    St-Petersburg Leningrad

  • Study site

    Voronezh

  • Study site

    Yaroslavl

  • Study site

    Yekaterinburg

Other trials in Russia

India6 sites

  • Study site

    Ahmedabad

  • Study site

    Bangalore

  • Study site

    Chennai

  • Study site

    Mumbai

  • Study site

    New Delhi

  • Study site

    Pune

Other trials in India

Poland6 sites

  • Study site

    Bydgoszcz

  • Study site

    Gdansk

  • Study site

    Inowrocław

  • Study site

    Kościerzyna

  • Study site

    Lodz

  • Study site

    Lublin

Other trials in Poland

Netherlands5 sites

  • Study site

    Apeldoorn

  • Study site

    Leiden

  • Study site

    Maastricht

  • Study site

    Nijmegen

  • Study site

    The Hague

Other trials in Netherlands

United Kingdom4 sites

  • Study site

    Cambridge

  • Study site

    Leicester

  • Study site

    Lincoln

  • Study site

    London

Other trials in United Kingdom

Austria3 sites

  • Study site

    Graz

  • Study site

    Vienna

  • Study site

    Wels

Other trials in Austria

South Africa3 sites

  • Study site

    Johannesburg Gauteng

  • Study site

    Pretoria

  • Study site

    Pretoria Gauteng

Other trials in South Africa

About this study

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

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).

Read the 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.

Being tested
Docetaxel, Prednisone, Intetumumab, Placebo
Keywords
Prostatic neoplasms, CNTO 95, Intetumumab, Docetaxel, Prednisone
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DocetaxelDrug

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

  • PrednisoneDrug

    Prednisone 5 mg orally twice daily.

  • IntetumumabBiological

    Also called CNTO 95

    Intetumumab 10 mg/kg as intravenous infusion every week for initial 6 weeks, then every 3 weeks.

  • PlaceboDrug

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

Study groups in NCT00537381
Study groupRoleWhat they receive
Docetaxel + Prednisone + PlaceboActive comparatorMatching 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.
Receives: Drug: Docetaxel; Drug: Prednisone; Drug: Placebo
Docetaxel + Prednisone + IntetumumabExperimentalIntetumumab 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.
Receives: Drug: Docetaxel; Drug: Prednisone; Biological: Intetumumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline up to 6 months after last dose of study treatment, assessed up to 551 days

Secondary outcomes (6)

  1. 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.

    Measured: Baseline up to 6 months after last dose of study treatment, assessed up to 551 days

  2. 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).

    Measured: Baseline up to 6 months after last dose of study treatment or early withdrawal, assessed up to 601 days

  3. 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.

    Measured: Baseline until death (up to 887 days)

  4. 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.

    Measured: Baseline, Week 6, 7, 10 and 13

  5. 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.

    Measured: Baseline, Week 6, 7, 10 and 13

  6. 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.

    Measured: Baseline, Week 6, 7, 10 and 13

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Oct 2007 (estimated)
  2. Study startMay 2007
  3. Primary completionNov 2009
  4. Study completionNov 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
131 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00537381
Sponsor's protocol ID
CR013249
Other IDs
C1034T08, 2006-005766-39
Status last verified
Jun 2013
First submitted
27 Sep 2007
Last updated
20 Jun 2013
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Docetaxel, Prednisone and Intetumumab in people with Prostatic Neoplasms, run by Centocor, Inc. at 59 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 59 sites in Belgium, Germany, United States, Russia, India and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 May 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-Free Survival (PFS) (time frame: Baseline up to 6 months after last dose of study treatment, assessed up to 551 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00537381.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2013.

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