A Study of the Safety and Efficacy of Single-agent CNTO 888 (an Anti CC-Chemokine Ligand 2 [CCL2]) in Patients With Metastatic Prostate Cancer

Tracking Information

Start Date  ICMJESeptember 2009
Primary Completion Date 
Current Primary Outcome Measures  ICMJE 
 (submitted: October 8, 2009)
To determine the composite response in patients with metastatic Castrate-Resistant Prostate Cancer (CRPC) who receive single-agent 15 mg/kg CNTO 888 every 2 weeks. [ Time Frame: 3-6 months ] [ Designated as safety issue: No ]
Original Primary Outcome Measures  ICMJESame as current
Change HistoryComplete list of historical versions of study NCT00992186 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE 
 (submitted: October 8, 2009)
  • Objective response rate determined as complete response and partial response according to Response Evaluation Criteria in Solid Tumors (RECIST) guidelines [ Time Frame: Patients will be treated every 2 weeks ] [ Designated as safety issue: No ]
  • Progression Free Survival [ Time Frame: Patients will be treated every 2 weeks ] [ Designated as safety issue: No ]
  • Overall Survival [ Time Frame: Patients will be treated every 2 weeks ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures  ICMJESame as current

Descriptive Information

Brief Title  ICMJEA Study of the Safety and Efficacy of Single-agent CNTO 888 (an Anti CC-Chemokine Ligand 2 [CCL2]) in Patients With Metastatic Prostate Cancer
Official Title  ICMJEAn Open-label, Multicenter, Phase 2 Study of Single-agent CNTO 888 (an Anti-CCL2 Monoclonal Antibody) for the Treatment of Patients With Metastatic Castrate-Resistant Prostate Cancer
Brief Summary

The purpose of this study is to determine the safety and effectiveness of the study drug CNTO 888 in patients with metastatic castrate-resistant prostate cancer.

Detailed Description

CNTO 888 is an antibody. Antibodies are substances in the body that are involved in many biological processes. CNTO 888 works by blocking a protein called "CC-Chemokine Ligand 2 (CCL2)". In research studies, CCL2 has been shown to increase the growth of new blood vessels, which help the tumor to survive. When new blood vessels do not grow, tumors cannot get the food or oxygen they need to grow. This study will evaluate the effect CCL2 has on prostate cancer growth. CNTO 888 is an experimental drug. Metastatic castrate-resistant prostate cancer is a type of prostate cancer that spreads from the prostate to other parts of the body. This kind of prostate cancer does not respond to medications that are typically used to lower hormone levels to slow the growth of cancer in the prostate. Patients enrolled in the study will receive 15mg/kg of CNTO888 intravenously (into the vein) every two weeks, until disease progression. Patients who experience toxicities may have their dose lowered to 10 mg/kg or discontinued. Safety assessments will be performed throughout the study including laboratory test evaluations, vital signs (e.g. blood pressure) and monitoring for the occurance and severity of adverse events. 15mg/kg once every 2 weeks until disease progression. Patient can have dose reduced to 10mg/kg once every 2 weeks if unresolved toxicity is experienced with 15mg/kg dose level.

Study PhasePhase II
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Condition  ICMJEProstate Cancer
Intervention  ICMJEDrug: CNTO888
15mg/kg intravenously every 2 weeks until disease progression.
Study Arms / Comparison Groups001: Experimental
CNTO888 15mg/kg intravenously every 2 weeks until disease progression.
Intervention: Drug: CNTO888

Recruitment Information

Estimated Enrollment  ICMJE43
Estimated Completion DateNovember 2011
Primary Completion Date 
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histological documentation of adenocarcinoma of the prostate
  • Received at least 1 but no more than 2 prior docetaxel-based chemotherapy regimens and had disease progression following the last therapy
  • Radiologic disease progression
  • Serum PSA >= 5.0 ng/mL within 4 weeks prior to the first dose of study agent

Exclusion Criteria:

  • Experience a hormonal treatment withdrawal response (including a lowering of PSA that was previously rising or symptomatic improvement)
  • Known or symptomatic Central Nervous System metastases
  • Residual toxicities resulting from previous therapy that are >= Grade 2 (except for alopecia)
  • Known allergies, hypersensitivity, or intolerance to CNTO 888 or its excipients or clinically significant reactions to chimeric or human proteins
Ages18 Years and older
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions:info1@veritasmedicine.com
Location Countries  ICMJEUnited States,   Belgium,   Russian Federation,   United Kingdom

Administrative Information

Responsible PartyDirector, Clinical Research, Centocor
Study ID Numbers  ICMJECR015907, 2009-011251-48
Study Sponsor  ICMJECentocor, Inc.
Collaborators  ICMJE 
Investigators  ICMJE
Study Director:Centocor, Inc. Clinical TrialCentocor, Inc.
Information Provided ByCentocor, Inc.