Trial Outcomes & Findings for S0354, Anti-IL-6 Chimeric Monoclonal Antibody in Patients With Metastatic Prostate Cancer That Did Not Respond to Hormone Therapy (NCT NCT00433446)
NCT ID: NCT00433446
Last Updated: 2013-02-05
Results Overview
PSA response is defined as a 50% reduction in accordance with the recommendations of the orginal PSA Working Group. Confirmed PSA response is defined as PSA response at two or more time points at least 4 weeks apart, without objective disease progression or symptomatic deterioration.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
62 participants
Primary outcome timeframe
Assessed every 3 cycles (1 cycle = 14 days) until progression
Results posted on
2013-02-05
Participant Flow
Participant milestones
| Measure |
CNTO 328
CNTO 328 will be given 6 mg/kg through intravenous (IV) once per cycle ( 1 cycle= 14 days) for 12 cycles
|
|---|---|
|
Overall Study
STARTED
|
62
|
|
Overall Study
Eligible
|
53
|
|
Overall Study
Eligible and Began Protocol Therapy
|
53
|
|
Overall Study
COMPLETED
|
1
|
|
Overall Study
NOT COMPLETED
|
61
|
Reasons for withdrawal
| Measure |
CNTO 328
CNTO 328 will be given 6 mg/kg through intravenous (IV) once per cycle ( 1 cycle= 14 days) for 12 cycles
|
|---|---|
|
Overall Study
Adverse Event
|
4
|
|
Overall Study
Refusal Unrelated to Adverse Event
|
1
|
|
Overall Study
Progression
|
44
|
|
Overall Study
Other - Not Protocol specified
|
3
|
|
Overall Study
Ineligible
|
9
|
Baseline Characteristics
S0354, Anti-IL-6 Chimeric Monoclonal Antibody in Patients With Metastatic Prostate Cancer That Did Not Respond to Hormone Therapy
Baseline characteristics by cohort
| Measure |
CNTO 328
n=53 Participants
CNTO 328 will be given 6 mg/kg through intravenous (IV) once per cycle ( 1 cycle= 14 days) for 12 cycles
|
|---|---|
|
Age Continuous
|
71 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
53 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
48 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
49 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Baseline PSA (ng/dL)
|
75.1 ng/dL
n=5 Participants
|
|
Performance Status
0
|
19 participants
n=5 Participants
|
|
Performance Status
1
|
28 participants
n=5 Participants
|
|
Performance Status
2
|
6 participants
n=5 Participants
|
|
Prior Taxane Therapy
Yes
|
53 participants
n=5 Participants
|
|
Prior Taxane Therapy
No
|
0 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Assessed every 3 cycles (1 cycle = 14 days) until progressionPopulation: All eligible patients who started treatment were included in the analysis
PSA response is defined as a 50% reduction in accordance with the recommendations of the orginal PSA Working Group. Confirmed PSA response is defined as PSA response at two or more time points at least 4 weeks apart, without objective disease progression or symptomatic deterioration.
Outcome measures
| Measure |
CNTO 328
n=53 Participants
CNTO 328 will be given 6 mg/kg through intravenous (IV) once per cycle ( 1 cycle= 14 days) for 12 cycles
|
|---|---|
|
Confirmed Prostate-Specific Antigen (PSA) Response
|
3.8 percentage of participants
Interval 0.5 to 13.0
|
SECONDARY outcome
Timeframe: Assessed every 3 cycles (1 cycle = 14 days) until progressionPopulation: All eligible patients who started treatment were included in the analysis
PFS is defined as tumor progression by Response Evaluation Criteria in Solid Tumors (RECIST) criteria, PSA progression by PSA Working Group criteria, or symptomatic deterioration.
Outcome measures
| Measure |
CNTO 328
n=53 Participants
CNTO 328 will be given 6 mg/kg through intravenous (IV) once per cycle ( 1 cycle= 14 days) for 12 cycles
|
|---|---|
|
Progression-free Survival (PFS)
|
1.6 months
Interval 1.6 to 1.7
|
SECONDARY outcome
Timeframe: 0-3 yeas after registrationPopulation: All eligible patients who started treatment were included in the analysis
Measured from date of registration to date of death due to any cause or last contact
Outcome measures
| Measure |
CNTO 328
n=53 Participants
CNTO 328 will be given 6 mg/kg through intravenous (IV) once per cycle ( 1 cycle= 14 days) for 12 cycles
|
|---|---|
|
Overall Survival (OS)
|
11.6 months
Interval 7.5 to 19.0
|
SECONDARY outcome
Timeframe: Assessed every 3 cycles (1 cycle= 14 days) of treatment until progressionPopulation: All eligible patients with measurable disease who started treatment were included in the analysis
Complete Response (CR) is a complete disappearance of all measurable and non-measurable disease. No new lesions. No disease related symptoms. PSA = .2 ng/ml. Partial Response (PR) applies only to patients with at least one measurable lesion. Greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions. No unequivocal progression of non-measurable disease. No new lesions.
Outcome measures
| Measure |
CNTO 328
n=31 Participants
CNTO 328 will be given 6 mg/kg through intravenous (IV) once per cycle ( 1 cycle= 14 days) for 12 cycles
|
|---|---|
|
Objective Response (Confirmed and Unconfirmed Complete and Partial Response) Among Those Patients With Measurable Disease
Complete Repsonse (CR)
|
0 participants
|
|
Objective Response (Confirmed and Unconfirmed Complete and Partial Response) Among Those Patients With Measurable Disease
Partial Response (PR)
|
0 participants
|
|
Objective Response (Confirmed and Unconfirmed Complete and Partial Response) Among Those Patients With Measurable Disease
Unconfirmed Complete Response
|
0 participants
|
|
Objective Response (Confirmed and Unconfirmed Complete and Partial Response) Among Those Patients With Measurable Disease
Unconfirmed Partial Response
|
0 participants
|
|
Objective Response (Confirmed and Unconfirmed Complete and Partial Response) Among Those Patients With Measurable Disease
Stable Disease
|
7 participants
|
|
Objective Response (Confirmed and Unconfirmed Complete and Partial Response) Among Those Patients With Measurable Disease
No response
|
24 participants
|
SECONDARY outcome
Timeframe: Patients were assessed for adverse events after every cycle (1 cycle = 14 days) of protocol treatmentPopulation: Eligible patients who had received any treatment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which deemed to be related to protocol treatment are included.
Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.
Outcome measures
| Measure |
CNTO 328
n=53 Participants
CNTO 328 will be given 6 mg/kg through intravenous (IV) once per cycle ( 1 cycle= 14 days) for 12 cycles
|
|---|---|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
AST, SGOT
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Alkaline phosphatase
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
CNS cerebrovascular ischemia
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
DIC (disseminated intravascular coagulation)
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Esophagitis
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Gastritis (including bile reflux gastritis)
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Leukocytes (total WBC)
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Neuropathy: motor
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Neutrophils/granulocytes (ANC/AGC)
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Pain - Muscle
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Pain-Other (Specify: hip and back)
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Platelets
|
2 Participants
|
Adverse Events
CNTO 328
Serious events: 9 serious events
Other events: 47 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CNTO 328
n=53 participants at risk
CNTO 328 will be given 6 mg/kg through intravenous (IV) once per cycle ( 1 cycle= 14 days) for 12 cycles
|
|---|---|
|
Blood and lymphatic system disorders
DIC (disseminated intravascular coagulation)
|
1.9%
1/53 • Patients were assessed for adverse events after every cycle (1 cycle = 14 days) of protocol treatment
|
|
Blood and lymphatic system disorders
Hemoglobin
|
1.9%
1/53 • Patients were assessed for adverse events after every cycle (1 cycle = 14 days) of protocol treatment
|
|
Gastrointestinal disorders
Esophagitis
|
1.9%
1/53 • Patients were assessed for adverse events after every cycle (1 cycle = 14 days) of protocol treatment
|
|
Gastrointestinal disorders
Gastritis (including bile reflux gastritis)
|
1.9%
1/53 • Patients were assessed for adverse events after every cycle (1 cycle = 14 days) of protocol treatment
|
|
General disorders
Extremity-lower (gait/walking)
|
1.9%
1/53 • Patients were assessed for adverse events after every cycle (1 cycle = 14 days) of protocol treatment
|
|
General disorders
Sudden death
|
1.9%
1/53 • Patients were assessed for adverse events after every cycle (1 cycle = 14 days) of protocol treatment
|
|
Musculoskeletal and connective tissue disorders
Pain - Back
|
1.9%
1/53 • Patients were assessed for adverse events after every cycle (1 cycle = 14 days) of protocol treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Death - Disease progression NOS
|
1.9%
1/53 • Patients were assessed for adverse events after every cycle (1 cycle = 14 days) of protocol treatment
|
|
Nervous system disorders
CNS cerebrovascular ischemia
|
1.9%
1/53 • Patients were assessed for adverse events after every cycle (1 cycle = 14 days) of protocol treatment
|
|
Nervous system disorders
Encephalopathy
|
1.9%
1/53 • Patients were assessed for adverse events after every cycle (1 cycle = 14 days) of protocol treatment
|
|
Nervous system disorders
Neuropathy: motor
|
1.9%
1/53 • Patients were assessed for adverse events after every cycle (1 cycle = 14 days) of protocol treatment
|
|
Renal and urinary disorders
Stricture/stenosis (incl anastomotic), GU - Ureter
|
1.9%
1/53 • Patients were assessed for adverse events after every cycle (1 cycle = 14 days) of protocol treatment
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
1.9%
1/53 • Patients were assessed for adverse events after every cycle (1 cycle = 14 days) of protocol treatment
|
|
Respiratory, thoracic and mediastinal disorders
Chylothorax
|
1.9%
1/53 • Patients were assessed for adverse events after every cycle (1 cycle = 14 days) of protocol treatment
|
|
Vascular disorders
Hematoma
|
1.9%
1/53 • Patients were assessed for adverse events after every cycle (1 cycle = 14 days) of protocol treatment
|
|
Vascular disorders
Vascular-Other (Specify)
|
1.9%
1/53 • Patients were assessed for adverse events after every cycle (1 cycle = 14 days) of protocol treatment
|
Other adverse events
| Measure |
CNTO 328
n=53 participants at risk
CNTO 328 will be given 6 mg/kg through intravenous (IV) once per cycle ( 1 cycle= 14 days) for 12 cycles
|
|---|---|
|
Blood and lymphatic system disorders
Hemoglobin
|
34.0%
18/53 • Patients were assessed for adverse events after every cycle (1 cycle = 14 days) of protocol treatment
|
|
Gastrointestinal disorders
Constipation
|
22.6%
12/53 • Patients were assessed for adverse events after every cycle (1 cycle = 14 days) of protocol treatment
|
|
Gastrointestinal disorders
Diarrhea
|
18.9%
10/53 • Patients were assessed for adverse events after every cycle (1 cycle = 14 days) of protocol treatment
|
|
Gastrointestinal disorders
Nausea
|
41.5%
22/53 • Patients were assessed for adverse events after every cycle (1 cycle = 14 days) of protocol treatment
|
|
Gastrointestinal disorders
Pain - Abdomen NOS
|
11.3%
6/53 • Patients were assessed for adverse events after every cycle (1 cycle = 14 days) of protocol treatment
|
|
Gastrointestinal disorders
Vomiting
|
18.9%
10/53 • Patients were assessed for adverse events after every cycle (1 cycle = 14 days) of protocol treatment
|
|
General disorders
Edema: limb
|
7.5%
4/53 • Patients were assessed for adverse events after every cycle (1 cycle = 14 days) of protocol treatment
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
52.8%
28/53 • Patients were assessed for adverse events after every cycle (1 cycle = 14 days) of protocol treatment
|
|
General disorders
Pain-Other (Specify)
|
13.2%
7/53 • Patients were assessed for adverse events after every cycle (1 cycle = 14 days) of protocol treatment
|
|
Investigations
ALT, SGPT (serum glutamic pyruvic transaminase)
|
7.5%
4/53 • Patients were assessed for adverse events after every cycle (1 cycle = 14 days) of protocol treatment
|
|
Investigations
AST, SGOT
|
18.9%
10/53 • Patients were assessed for adverse events after every cycle (1 cycle = 14 days) of protocol treatment
|
|
Investigations
Alkaline phosphatase
|
20.8%
11/53 • Patients were assessed for adverse events after every cycle (1 cycle = 14 days) of protocol treatment
|
|
Investigations
Bilirubin (hyperbilirubinemia)
|
5.7%
3/53 • Patients were assessed for adverse events after every cycle (1 cycle = 14 days) of protocol treatment
|
|
Investigations
INR (of prothrombin time)
|
5.7%
3/53 • Patients were assessed for adverse events after every cycle (1 cycle = 14 days) of protocol treatment
|
|
Investigations
Leukocytes (total WBC)
|
28.3%
15/53 • Patients were assessed for adverse events after every cycle (1 cycle = 14 days) of protocol treatment
|
|
Investigations
Lymphopenia
|
13.2%
7/53 • Patients were assessed for adverse events after every cycle (1 cycle = 14 days) of protocol treatment
|
|
Investigations
Metabolic/Laboratory-Other (Specify)
|
5.7%
3/53 • Patients were assessed for adverse events after every cycle (1 cycle = 14 days) of protocol treatment
|
|
Investigations
Neutrophils/granulocytes (ANC/AGC)
|
11.3%
6/53 • Patients were assessed for adverse events after every cycle (1 cycle = 14 days) of protocol treatment
|
|
Investigations
Platelets
|
17.0%
9/53 • Patients were assessed for adverse events after every cycle (1 cycle = 14 days) of protocol treatment
|
|
Investigations
Weight loss
|
5.7%
3/53 • Patients were assessed for adverse events after every cycle (1 cycle = 14 days) of protocol treatment
|
|
Metabolism and nutrition disorders
Anorexia
|
15.1%
8/53 • Patients were assessed for adverse events after every cycle (1 cycle = 14 days) of protocol treatment
|
|
Metabolism and nutrition disorders
Calcium, serum-low (hypocalcemia)
|
9.4%
5/53 • Patients were assessed for adverse events after every cycle (1 cycle = 14 days) of protocol treatment
|
|
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)
|
24.5%
13/53 • Patients were assessed for adverse events after every cycle (1 cycle = 14 days) of protocol treatment
|
|
Musculoskeletal and connective tissue disorders
Pain - Back
|
22.6%
12/53 • Patients were assessed for adverse events after every cycle (1 cycle = 14 days) of protocol treatment
|
|
Musculoskeletal and connective tissue disorders
Pain - Bone
|
5.7%
3/53 • Patients were assessed for adverse events after every cycle (1 cycle = 14 days) of protocol treatment
|
|
Musculoskeletal and connective tissue disorders
Pain - Extremity-limb
|
9.4%
5/53 • Patients were assessed for adverse events after every cycle (1 cycle = 14 days) of protocol treatment
|
|
Musculoskeletal and connective tissue disorders
Pain - Joint
|
13.2%
7/53 • Patients were assessed for adverse events after every cycle (1 cycle = 14 days) of protocol treatment
|
|
Nervous system disorders
Dizziness
|
17.0%
9/53 • Patients were assessed for adverse events after every cycle (1 cycle = 14 days) of protocol treatment
|
|
Nervous system disorders
Neuropathy: sensory
|
20.8%
11/53 • Patients were assessed for adverse events after every cycle (1 cycle = 14 days) of protocol treatment
|
|
Nervous system disorders
Pain - Head/headache
|
7.5%
4/53 • Patients were assessed for adverse events after every cycle (1 cycle = 14 days) of protocol treatment
|
|
Psychiatric disorders
Insomnia
|
9.4%
5/53 • Patients were assessed for adverse events after every cycle (1 cycle = 14 days) of protocol treatment
|
|
Renal and urinary disorders
Urinary retention (including neurogenic bladder)
|
5.7%
3/53 • Patients were assessed for adverse events after every cycle (1 cycle = 14 days) of protocol treatment
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
5.7%
3/53 • Patients were assessed for adverse events after every cycle (1 cycle = 14 days) of protocol treatment
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.7%
3/53 • Patients were assessed for adverse events after every cycle (1 cycle = 14 days) of protocol treatment
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
20.8%
11/53 • Patients were assessed for adverse events after every cycle (1 cycle = 14 days) of protocol treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion (non-malignant)
|
5.7%
3/53 • Patients were assessed for adverse events after every cycle (1 cycle = 14 days) of protocol treatment
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
7.5%
4/53 • Patients were assessed for adverse events after every cycle (1 cycle = 14 days) of protocol treatment
|
|
Vascular disorders
Hot flashes/flushes
|
7.5%
4/53 • Patients were assessed for adverse events after every cycle (1 cycle = 14 days) of protocol treatment
|
|
Vascular disorders
Hypotension
|
7.5%
4/53 • Patients were assessed for adverse events after every cycle (1 cycle = 14 days) of protocol treatment
|
Additional Information
Study Statistician
SWOG Statistical Center
Phone: 206-667-4623
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place