S0354, Anti-IL-6 Chimeric Monoclonal Antibody in Patients With Metastatic Prostate Cancer That Did Not Respond to Hormone Therapy

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT00433446
First received: February 8, 2007
Last updated: January 2, 2013
Last verified: January 2013
Results First Received: November 9, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Prostate Cancer
Intervention: Biological: CNTO 328

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
CNTO 328 CNTO 328 will be given 6 mg/kg through intravenous (IV) once per cycle ( 1 cycle= 14 days) for 12 cycles

Participant Flow:   Overall Study
    CNTO 328  
STARTED     62  
Eligible     53  
Eligible and Began Protocol Therapy     53  
COMPLETED     1  
NOT COMPLETED     61  
Adverse Event                 4  
Refusal Unrelated to Adverse Event                 1  
Progression                 44  
Other - Not Protocol specified                 3  
Ineligible                 9  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
CNTO 328 CNTO 328 will be given 6 mg/kg through intravenous (IV) once per cycle ( 1 cycle= 14 days) for 12 cycles

Baseline Measures
    CNTO 328  
Number of Participants  
[units: participants]
  53  
Age  
[units: years]
Median ( Full Range )
  71  
  ( 46 to 92 )  
Gender  
[units: participants]
 
Female     0  
Male     53  
Ethnicity (NIH/OMB)  
[units: participants]
 
Hispanic or Latino     1  
Not Hispanic or Latino     48  
Unknown or Not Reported     4  
Race (NIH/OMB)  
[units: participants]
 
American Indian or Alaska Native     0  
Asian     1  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     3  
White     49  
More than one race     0  
Unknown or Not Reported     0  
Baseline PSA (ng/dL)  
[units: ng/dL]
Median ( Full Range )
  75.1  
  ( 6.3 to 10181 )  
Performance Status [1]
[units: participants]
 
0     19  
1     28  
2     6  
Prior Taxane Therapy  
[units: participants]
 
Yes     53  
No     0  
[1] Patients will be graded according to the Zubrod performance status scale. 0: Fully active, able to carry all pre-disease performance without restriction. 1: Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature. 2: Ambulatory and capable of self-care but unable to carry out any work activities; up and about more than 50% of waking hours. 3: Capable of limited self-care, confined to bed or chair more than 50% of waking hours. 4: Completely disabled; cannot carry on any self-care; totally confined to bed or chair.



  Outcome Measures
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1.  Primary:   Confirmed Prostate-Specific Antigen (PSA) Response   [ Time Frame: Assessed every 3 cycles (1 cycle = 14 days) until progression ]

2.  Secondary:   Progression-free Survival (PFS)   [ Time Frame: Assessed every 3 cycles (1 cycle = 14 days) until progression ]

3.  Secondary:   Overall Survival (OS)   [ Time Frame: 0-3 yeas after registration ]

4.  Secondary:   Objective Response (Confirmed and Unconfirmed Complete and Partial Response) Among Those Patients With Measurable Disease   [ Time Frame: Assessed every 3 cycles (1 cycle= 14 days) of treatment until progression ]

5.  Secondary:   Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug   [ Time Frame: Patients were assessed for adverse events after every cycle (1 cycle = 14 days) of protocol treatment ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Study Statistician
Organization: SWOG Statistical Center
phone: 206-667-4623


Publications of Results:
Pinski JK, Goldman B, Dorff T, et al.: SWOG S0354: A phase II trial of CNTO328, a monoclonal antibody against interleukin-6 (IL-6), in chemotherapy pretreated patients (pts) with castration- resistant prostate cancer (CRPC). [Abstract] J Clin Oncol 27 (Suppl 15): A-5143, 2009.


Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00433446     History of Changes
Other Study ID Numbers: CDR0000526555, U10CA032102, S0354
Study First Received: February 8, 2007
Results First Received: November 9, 2012
Last Updated: January 2, 2013
Health Authority: United States: Food and Drug Administration