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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00433446
Recruitment Status : Completed
First Posted : February 12, 2007
Results First Posted : February 5, 2013
Last Update Posted : February 5, 2013
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Southwest Oncology Group

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Prostate Cancer
Intervention: Biological: CNTO 328

  Participant Flow

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
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
Eligible   53 
Eligible and Began Protocol Therapy   53 
Adverse Event                4 
Refusal Unrelated to Adverse Event                1 
Progression                44 
Other - Not Protocol specified                3 
Ineligible                9 

  Baseline Characteristics

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
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 
Overall Participants Analyzed 
[Units: Participants]
[Units: Years]
Median (Full Range)
 (46 to 92) 
[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)
 (6.3 to 10181) 
Performance Status [1] 
[Units: Participants]
[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.
Prior Taxane Therapy 
[Units: Participants]
Yes   53 
No   0 

  Outcome Measures

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

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

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:

Responsible Party: Southwest Oncology Group Identifier: NCT00433446     History of Changes
Other Study ID Numbers: CDR0000526555
U10CA032102 ( U.S. NIH Grant/Contract )
S0354 ( Other Identifier: SWOG )
First Submitted: February 8, 2007
First Posted: February 12, 2007
Results First Submitted: November 9, 2012
Results First Posted: February 5, 2013
Last Update Posted: February 5, 2013