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:
Southwest Oncology Group
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
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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
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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| No text entered. |
Pre-Assignment Details
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
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| No text entered. |
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
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
| 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 ] |
More Information
Certain Agreements:
Limitations and Caveats
Results Point of Contact:
Publications of Results:
| 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. |
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 |
|---|
| No text entered. |
Results Point of Contact:
Name/Title: Study Statistician
Organization: SWOG Statistical Center
phone: 206-667-4623
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 |