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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 - NCT00992186-(Clinical Trial 368573)



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City:  Charleston
State:  
SC
Zip Code:
Conditions: Prostate Cancer
Purpose: 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.
Study summary: 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.
Criteria: 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
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Data Source: ClinicalTrials.gov
Date Processed: January 6, 2011
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