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

• Sponsor: Southwest Oncology Group (Other)
• Overall Status: Completed
• CT.gov ID: NCT00433446
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 62
• Locations: 123
• Arm: 1
• Duration (Months): 51
• Patients Per Site: 0.5
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

RATIONALE: Monoclonal antibodies, such as anti-IL-6 chimeric monoclonal antibody, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them.

PURPOSE: This phase II trial is studying how well anti-IL-6 chimeric monoclonal antibody works in treating patients with metastatic prostate cancer that did not respond to hormone therapy.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer	Biological: CNTO 328	Phase 2

Detailed Description

OBJECTIVES:

Primary

• Assess the confirmed prostate-specific antigen response in patients with hormone-refractory metastatic prostate cancer treated with anti-IL-6 chimeric monoclonal antibody.

Secondary

• Assess overall survival and progression-free survival of these patients.

• Assess the objective response rate (confirmed and unconfirmed, complete and partial response) in patients with measurable disease treated with this regimen.

• Assess the qualitative and quantitative toxicities of this regimen.

OUTLINE: This is an open-label, multicenter study.

Patients receive anti-IL-6 chimeric monoclonal antibody IV over 2 hours on day 1. Treatment repeats every 2 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months for 1 year and then every 6 months for up to 2 years.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.

Study Design

• Study Type: Interventional
• Actual Enrollment: 62 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase II Study of CNTO 328, A Monoclonal Antibody Against Interleukin-6 (IL-6), in Patients With Hormone Refractory Prostate Cancer
• Study Start Date: Apr 1, 2007
• Actual Primary Completion Date: May 1, 2009
• Actual Study Completion Date: Jul 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CNTO 328	Biological: CNTO 328; Other Names: anti-IL-6 chimeric monoclonal antibody

Outcome Measures

Primary Outcome Measures

1. Confirmed Prostate-Specific Antigen (PSA) Response [Assessed every 3 cycles (1 cycle = 14 days) until progression]

   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.

Secondary Outcome Measures

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

   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.

2. Overall Survival (OS) [0-3 yeas after registration]

   Measured from date of registration to date of death due to any cause or last contact

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

   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.

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

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

DISEASE CHARACTERISTICS:

• Histologically confirmed adenocarcinoma of the prostate

• Metastatic disease (N1 and/or M1)

• Disease unresponsive or refractory to androgen-deprivation therapy

• Must have received only 1 prior chemotherapy regimen comprising a taxane OR mitoxantrone

• Disease progression as defined by one or more of the following:

• Progression of measurable disease

• Prior radiotherapy allowed provided radiotherapy was completed ≥ 2 months ago and lesion progressed since radiotherapy

• Progression of nonmeasurable disease

• Prior radiotherapy within the past 2 months allowed, but disease is considered nonmeasurable

• Rising prostate-specific antigen (PSA) after > 2 courses of chemotherapy OR within 6 months of last chemotherapy dose

• Rising PSA defined as at least 2 consecutive rises in PSA to be documented over a reference value (measure 1)

• PSA ≥ 5 ng/mL

• Surgical or medical castration required

• Castration using luteinizing hormone-releasing hormone agonist (leuprolide acetate or goserelin) or antagonist (abarelix) should not be interrupted

• No history of brain metastases OR currently treated or untreated brain metastases

• Patients with clinical suspicion of brain metastases must have a brain CT scan or MRI negative for metastatic disease within the past 56 days

PATIENT CHARACTERISTICS:

• Zubrod performance status 0-2

• Fertile patients must use effective contraception

• Absolute granulocyte count ≥ 1,500/mm³ (transfusion independent)

• Platelet count ≥ 100,000/mm³ (transfusion independent)

• Hemoglobin ≥ 9 g/dL (transfusion independent)

• Creatinine clearance ≥ 40 mL/min

• Bilirubin ≤ 2 times upper limit of normal (ULN)

• Aspartate aminotransferase (AST) ≤ 2 times ULN

• No uncontrolled intercurrent illnesses including, but not limited to, the following:

• Diabetes mellitus

• Ongoing or active infection

• Symptomatic congestive heart failure

• Unstable angina pectoris

• Cardiac arrhythmia

• No psychiatric illness or social situation that would preclude study compliance

• No known HIV positivity

• No other prior malignancy except for the following:

• Adequately treated basal cell or squamous cell skin cancer

• Adequately treated stage I or II cancer in complete remission

• Any other cancer from which the patient has been disease-free for 5 years

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• At least 21 days since prior surgery and recovered

• At least 28 days since prior chemotherapy and recovered

• At least 28 days since prior flutamide or ketoconazole

• At least 28 days since prior radiotherapy (to < 30% of the bone marrow only) and recovered

• Prior samarium Sm 153 lexidronam pentasodium allowed

• No prior strontium chloride Sr 89

• At least 42 days since prior bicalutamide or nilutamide

• More than 60 days since prior murine or chimeric proteins or human/murine monoclonal antibody

• Concurrent bisphosphonate therapy allowed provided the following are true:

• Therapy commenced at least 3 weeks ago

• Therapy continues for the entire duration of study treatment

• No other concurrent anticancer therapy, including cytotoxic therapy, biologic therapy, radiotherapy, or hormonal therapy (except for luteinizing hormone-releasing hormone agonist or antagonist in patients who have not had an orchiectomy)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Regional Medical Center	Anniston	Alabama	United States	36202
2	Highlands Oncology Group - Springdale	Springdale	Arkansas	United States	72764
3	Alta Bates Summit Comprehensive Cancer Center	Berkeley	California	United States	94704
4	Peninsula Medical Center	Burlingame	California	United States	94010
5	Glendale Memorial Hospital Comprehensive Cancer Center	Glendale	California	United States	91204
6	Marin Cancer Institute at Marin General Hospital	Greenbrae	California	United States	94904
7	Sutter Health - Western Division Cancer Research Group	Greenbrae	California	United States	94904
8	USC/Norris Comprehensive Cancer Center and Hospital	Los Angeles	California	United States	90089-9181
9	University of California Davis Cancer Center	Sacramento	California	United States	95817
10	California Pacific Medical Center - California Campus	San Francisco	California	United States	94118
11	Sutter Solano Medical Center	Vallejo	California	United States	94589
12	Poudre Valley Hospital	Fort Collins	Colorado	United States	80524
13	M.D. Anderson Cancer Center at Orlando	Orlando	Florida	United States	32806
14	Veterans Affairs Medical Center - Hines	Hines	Illinois	United States	60141
15	Genesis Regional Cancer Center at Genesis Medical Center	Davenport	Iowa	United States	52803
16	Cancer Center of Kansas, PA - Chanute	Chanute	Kansas	United States	66720
17	Cancer Center of Kansas, PA - Dodge City	Dodge City	Kansas	United States	67801
18	Cancer Center of Kansas, PA - El Dorado	El Dorado	Kansas	United States	67042
19	Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center	Kansas City	Kansas	United States	66160-7357
20	Cancer Center of Kansas, PA - Kingman	Kingman	Kansas	United States	67068
21	Southwest Medical Center	Liberal	Kansas	United States	67901
22	Cancer Center of Kansas, PA - Newton	Newton	Kansas	United States	67114
23	Cancer Center of Kansas, PA - Parsons	Parsons	Kansas	United States	67357
24	Cancer Center of Kansas, PA - Pratt	Pratt	Kansas	United States	67124
25	Cancer Center of Kansas, PA - Salina	Salina	Kansas	United States	67042
26	Cancer Center of Kansas, PA - Wellington	Wellington	Kansas	United States	67152
27	Associates in Womens Health, PA - North Review	Wichita	Kansas	United States	67203
28	Cancer Center of Kansas, PA - Medical Arts Tower	Wichita	Kansas	United States	67208
29	Cancer Center of Kansas, PA - Wichita	Wichita	Kansas	United States	67214
30	CCOP - Wichita	Wichita	Kansas	United States	67214
31	Via Christi Cancer Center at Via Christi Regional Medical Center	Wichita	Kansas	United States	67214
32	Cancer Center of Kansas, PA - Winfield	Winfield	Kansas	United States	67156
33	Pennington Cancer Center at Baton Rouge General	Baton Rouge	Louisiana	United States	70806
34	Mary Bird Perkins Cancer Center - Baton Rouge	Baton Rouge	Louisiana	United States	70809
35	MBCCOP - LSU Health Sciences Center	New Orleans	Louisiana	United States	70112
36	Medical Center of Louisiana - New Orleans	New Orleans	Louisiana	United States	70112
37	Saint Joseph Mercy Cancer Center	Ann Arbor	Michigan	United States	48106-0995
38	CCOP - Michigan Cancer Research Consortium	Ann Arbor	Michigan	United States	48106
39	University of Michigan Comprehensive Cancer Center	Ann Arbor	Michigan	United States	48109-0942
40	Battle Creek Health System Cancer Care Center	Battle Creek	Michigan	United States	49017
41	Mecosta County Medical Center	Big Rapids	Michigan	United States	49307
42	Oakwood Cancer Center at Oakwood Hospital and Medical Center	Dearborn	Michigan	United States	48123-2500
43	Genesys Hurley Cancer Institute	Flint	Michigan	United States	48503
44	Hurley Medical Center	Flint	Michigan	United States	48503
45	Butterworth Hospital at Spectrum Health	Grand Rapids	Michigan	United States	49503
46	CCOP - Grand Rapids	Grand Rapids	Michigan	United States	49503
47	Lacks Cancer Center at Saint Mary's Health Care	Grand Rapids	Michigan	United States	49503
48	Metro Health Hospital	Grand Rapids	Michigan	United States	49506
49	Van Elslander Cancer Center at St. John Hospital and Medical Center	Grosse Pointe Woods	Michigan	United States	48236
50	Holland Community Hospital	Holland	Michigan	United States	49423
51	Foote Memorial Hospital	Jackson	Michigan	United States	49201
52	Sparrow Regional Cancer Center	Lansing	Michigan	United States	48912-1811
53	St. Mary Mercy Hospital	Livonia	Michigan	United States	48154
54	Ted B. Wahby Cancer Center at Mount Clemens General Hospital	Mount Clemens	Michigan	United States	48043
55	Hackley Hospital	Muskegon	Michigan	United States	49442
56	St. Joseph Mercy Oakland	Pontiac	Michigan	United States	48341-2985
57	Mercy Regional Cancer Center at Mercy Hospital	Port Huron	Michigan	United States	48060
58	Seton Cancer Institute at Saint Mary's - Saginaw	Saginaw	Michigan	United States	48601
59	Munson Medical Center	Traverse City	Michigan	United States	49684
60	St. John Macomb Hospital	Warren	Michigan	United States	48093
61	University of Mississippi Cancer Clinic	Jackson	Mississippi	United States	39216
62	CCOP - Cancer Research for the Ozarks	Springfield	Missouri	United States	65802
63	St. John's Regional Health Center	Springfield	Missouri	United States	65804
64	Hulston Cancer Center at Cox Medical Center South	Springfield	Missouri	United States	65807
65	CCOP - Montana Cancer Consortium	Billings	Montana	United States	59101
66	Hematology-Oncology Centers of the Northern Rockies - Billings	Billings	Montana	United States	59101
67	Northern Rockies Radiation Oncology Center	Billings	Montana	United States	59101
68	St. Vincent Healthcare Cancer Care Services	Billings	Montana	United States	59101
69	Billings Clinic - Downtown	Billings	Montana	United States	59107-7000
70	Bozeman Deaconess Cancer Center	Bozeman	Montana	United States	59715
71	St. James Healthcare Cancer Care	Butte	Montana	United States	59701
72	Big Sky Oncology	Great Falls	Montana	United States	59405-5309
73	Great Falls Clinic - Main Facility	Great Falls	Montana	United States	59405
74	Sletten Cancer Institute at Benefis Healthcare	Great Falls	Montana	United States	59405
75		Great Falls	Montana	United States	59405
76	St. Peter's Hospital	Helena	Montana	United States	59601
77	Glacier Oncology, PLLC	Kalispell	Montana	United States	59901
78	Kalispell Medical Oncology at KRMC	Kalispell	Montana	United States	59901
79	Kalispell Regional Medical Center	Kalispell	Montana	United States	59901
80	Community Medical Center	Missoula	Montana	United States	59801
81	Guardian Oncology and Center for Wellness	Missoula	Montana	United States	59804
82	Montana Cancer Specialists at Montana Cancer Center	Missoula	Montana	United States	59807-7877
83	Montana Cancer Center at St. Patrick Hospital and Health Sciences Center	Missoula	Montana	United States	59807
84	Good Samaritan Cancer Center at Good Samaritan Hospital	Kearney	Nebraska	United States	68848-1990
85	Tucker Center for Cancer Care at Orange Regional Medical Center	Middletown	New York	United States	10940-4199
86	Interlakes Oncology/Hematology PC	Rochester	New York	United States	14623
87	James P. Wilmot Cancer Center at University of Rochester Medical Center	Rochester	New York	United States	14642
88	Presbyterian Cancer Center at Presbyterian Hospital	Charlotte	North Carolina	United States	28233-3549
89	Wayne Memorial Hospital, Incorporated	Goldsboro	North Carolina	United States	27534
90	Pardee Memorial Hospital	Hendersonville	North Carolina	United States	28791
91	Rutherford Hospital	Rutherfordton	North Carolina	United States	28139
92	Legacy Mount Hood Medical Center	Gresham	Oregon	United States	97030
93	Providence Milwaukie Hospital	Milwaukie	Oregon	United States	97222
94	Legacy Good Samaritan Hospital & Comprehensive Cancer Center	Portland	Oregon	United States	97210
95	Providence Cancer Center at Providence Portland Medical Center	Portland	Oregon	United States	97213-2967
96	Adventist Medical Center	Portland	Oregon	United States	97216
97	CCOP - Columbia River Oncology Program	Portland	Oregon	United States	97225
98	Providence St. Vincent Medical Center	Portland	Oregon	United States	97225
99	Legacy Emanuel Hospital and Health Center and Children's Hospital	Portland	Oregon	United States	97227
100	Legacy Meridian Park Hospital	Tualatin	Oregon	United States	97062
101	AnMed Cancer Center	Anderson	South Carolina	United States	29621
102	CCOP - Upstate Carolina	Spartanburg	South Carolina	United States	29303
103	Gibbs Regional Cancer Center at Spartanburg Regional Medical Center	Spartanburg	South Carolina	United States	29303
104	Veterans Affairs Medical Center - San Antonio (Murphy)	San Antonio	Texas	United States	78209
105	University of Texas Health Science Center at San Antonio	San Antonio	Texas	United States	78229-3900
106	Cancer Therapy and Research Center	San Antonio	Texas	United States	78229
107	University Hospital - San Antonio	San Antonio	Texas	United States	78229
108	Danville Regional Medical Center	Danville	Virginia	United States	24541
109	Ravenel Oncology Center at Memorial Hospital of Martinsville and Henry County	Martinsville	Virginia	United States	24115
110	St. Joseph Cancer Center	Bellingham	Washington	United States	98225
111	Olympic Hematology and Oncology	Bremerton	Washington	United States	98310
112	Columbia Basin Hematology	Kennewick	Washington	United States	99336
113	Fred Hutchinson Cancer Research Center	Seattle	Washington	United States	98104
114	Harborview Medical Center	Seattle	Washington	United States	98104
115	Minor and James Medical, PLLC	Seattle	Washington	United States	98104
116	Group Health Central Hospital	Seattle	Washington	United States	98112
117	Swedish Cancer Institute at Swedish Medical Center - First Hill Campus	Seattle	Washington	United States	98122-4307
118	Polyclinic First Hill	Seattle	Washington	United States	98122
119	University Cancer Center at University of Washington Medical Center	Seattle	Washington	United States	98195-6043
120	Cancer Care Northwest - Spokane South	Spokane	Washington	United States	99202
121	Southwest Washington Medical Center Cancer Center	Vancouver	Washington	United States	98668
122	Wenatchee Valley Medical Center	Wenatchee	Washington	United States	98801-2028
123	Welch Cancer Center at Sheridan Memorial Hospital	Sheridan	Wyoming	United States	82801

Sponsors and Collaborators

• Southwest Oncology Group
• National Cancer Institute (NCI)

Investigators

• Study Chair: Jacek Pinski, MD, University of Southern California

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Southwest Oncology Group
• ClinicalTrials.gov Identifier: NCT00433446
• Other Study ID Numbers: CDR0000526555; U10CA032102; S0354
• First Posted: Feb 12, 2007
• Last Update Posted: Feb 5, 2013
• Last Verified: Jan 1, 2013

• Keywords provided by Southwest Oncology Group: adenocarcinoma of the prostate; stage IV prostate cancer; recurrent prostate cancer
• Additional relevant MeSH terms: Prostatic Neoplasms; Siltuximab

Study Results

Participant Flow

Arm/Group Title	CNTO 328
Arm/Group Description	CNTO 328 will be given 6 mg/kg through intravenous (IV) once per cycle ( 1 cycle= 14 days) for 12 cycles
Period Title: Overall Study
STARTED	62
Eligible	53
Eligible and Began Protocol Therapy	53
COMPLETED	1
NOT COMPLETED	61

Baseline Characteristics

Arm/Group Title	CNTO 328
Arm/Group Description	CNTO 328 will be given 6 mg/kg through intravenous (IV) once per cycle ( 1 cycle= 14 days) for 12 cycles
Overall Participants	53
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	71
Sex: Female, Male (Count of Participants)
Female	0 0%
Male	53 100%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	1 1.9%
Not Hispanic or Latino	48 90.6%
Unknown or Not Reported	4 7.5%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	1 1.9%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	3 5.7%
White	49 92.5%
More than one race	0 0%
Unknown or Not Reported	0 0%
Baseline PSA (ng/dL) (ng/dL) [Median (Full Range) ]
Median (Full Range) [ng/dL]	75.1
Performance Status (participants) [Number]
0	19 35.8%
1	28 52.8%
2	6 11.3%
Prior Taxane Therapy (participants) [Number]
Yes	53 100%
No	0 0%

Outcome Measures

1. Secondary Outcome

Title	Progression-free Survival (PFS)
Description	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.
Time Frame	Assessed every 3 cycles (1 cycle = 14 days) until progression

Outcome Measure Data

Analysis Population Description

All eligible patients who started treatment were included in the analysis

Arm/Group Title	CNTO 328
Arm/Group Description	CNTO 328 will be given 6 mg/kg through intravenous (IV) once per cycle ( 1 cycle= 14 days) for 12 cycles
Measure Participants	53
Median (95% Confidence Interval) [months]	1.6

2. Primary Outcome

Title	Confirmed Prostate-Specific Antigen (PSA) Response
Description	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.
Time Frame	Assessed every 3 cycles (1 cycle = 14 days) until progression

Outcome Measure Data

Analysis Population Description

All eligible patients who started treatment were included in the analysis

Arm/Group Title	CNTO 328
Arm/Group Description	CNTO 328 will be given 6 mg/kg through intravenous (IV) once per cycle ( 1 cycle= 14 days) for 12 cycles
Measure Participants	53
Number (95% Confidence Interval) [percentage of participants]	3.8 7.2%

3. Secondary Outcome

Title	Overall Survival (OS)
Description	Measured from date of registration to date of death due to any cause or last contact
Time Frame	0-3 yeas after registration

Outcome Measure Data

Analysis Population Description

All eligible patients who started treatment were included in the analysis

Arm/Group Title	CNTO 328
Arm/Group Description	CNTO 328 will be given 6 mg/kg through intravenous (IV) once per cycle ( 1 cycle= 14 days) for 12 cycles
Measure Participants	53
Median (95% Confidence Interval) [months]	11.6

4. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

All eligible patients with measurable disease who started treatment were included in the analysis

Arm/Group Title	CNTO 328
Arm/Group Description	CNTO 328 will be given 6 mg/kg through intravenous (IV) once per cycle ( 1 cycle= 14 days) for 12 cycles
Measure Participants	31
Complete Repsonse (CR)	0 0%
Partial Response (PR)	0 0%
Unconfirmed Complete Response	0 0%
Unconfirmed Partial Response	0 0%
Stable Disease	7 13.2%
No response	24 45.3%

5. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	CNTO 328
Arm/Group Description	CNTO 328 will be given 6 mg/kg through intravenous (IV) once per cycle ( 1 cycle= 14 days) for 12 cycles
Measure Participants	53
AST, SGOT	1 1.9%
Alkaline phosphatase	1 1.9%
CNS cerebrovascular ischemia	1 1.9%
DIC (disseminated intravascular coagulation)	1 1.9%
Esophagitis	1 1.9%
Gastritis (including bile reflux gastritis)	1 1.9%
Leukocytes (total WBC)	1 1.9%
Neuropathy: motor	1 1.9%
Neutrophils/granulocytes (ANC/AGC)	1 1.9%
Pain - Muscle	1 1.9%
Pain-Other (Specify: hip and back)	1 1.9%
Platelets	2 3.8%

Adverse Events

Time Frame	Patients were assessed for adverse events after every cycle (1 cycle = 14 days) of protocol treatment
Arm/Group Title	CNTO 328
Arm/Group Description	CNTO 328 will be given 6 mg/kg through intravenous (IV) once per cycle ( 1 cycle= 14 days) for 12 cycles
All Cause Mortality
	CNTO 328
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	CNTO 328
	Affected / at Risk (%)	# Events
Total	9/53 (17%)
Blood and lymphatic system disorders
DIC (disseminated intravascular coagulation)	1/53 (1.9%)
Hemoglobin	1/53 (1.9%)
Gastrointestinal disorders
Esophagitis	1/53 (1.9%)
Gastritis (including bile reflux gastritis)	1/53 (1.9%)
General disorders
Extremity-lower (gait/walking)	1/53 (1.9%)
Sudden death	1/53 (1.9%)
Musculoskeletal and connective tissue disorders
Pain - Back	1/53 (1.9%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Death - Disease progression NOS	1/53 (1.9%)
Nervous system disorders
CNS cerebrovascular ischemia	1/53 (1.9%)
Encephalopathy	1/53 (1.9%)
Neuropathy: motor	1/53 (1.9%)
Renal and urinary disorders
Stricture/stenosis (incl anastomotic), GU - Ureter	1/53 (1.9%)
Respiratory, thoracic and mediastinal disorders
Aspiration	1/53 (1.9%)
Chylothorax	1/53 (1.9%)
Vascular disorders
Hematoma	1/53 (1.9%)
Vascular-Other (Specify)	1/53 (1.9%)
Other (Not Including Serious) Adverse Events
	CNTO 328
	Affected / at Risk (%)	# Events
Total	47/53 (88.7%)
Blood and lymphatic system disorders
Hemoglobin	18/53 (34%)
Gastrointestinal disorders
Constipation	12/53 (22.6%)
Diarrhea	10/53 (18.9%)
Nausea	22/53 (41.5%)
Pain - Abdomen NOS	6/53 (11.3%)
Vomiting	10/53 (18.9%)
General disorders
Edema: limb	4/53 (7.5%)
Fatigue (asthenia, lethargy, malaise)	28/53 (52.8%)
Pain-Other (Specify)	7/53 (13.2%)
Investigations
ALT, SGPT (serum glutamic pyruvic transaminase)	4/53 (7.5%)
AST, SGOT	10/53 (18.9%)
Alkaline phosphatase	11/53 (20.8%)
Bilirubin (hyperbilirubinemia)	3/53 (5.7%)
INR (of prothrombin time)	3/53 (5.7%)
Leukocytes (total WBC)	15/53 (28.3%)
Lymphopenia	7/53 (13.2%)
Metabolic/Laboratory-Other (Specify)	3/53 (5.7%)
Neutrophils/granulocytes (ANC/AGC)	6/53 (11.3%)
Platelets	9/53 (17%)
Weight loss	3/53 (5.7%)
Metabolism and nutrition disorders
Anorexia	8/53 (15.1%)
Calcium, serum-low (hypocalcemia)	5/53 (9.4%)
Glucose, serum-high (hyperglycemia)	13/53 (24.5%)
Musculoskeletal and connective tissue disorders
Pain - Back	12/53 (22.6%)
Pain - Bone	3/53 (5.7%)
Pain - Extremity-limb	5/53 (9.4%)
Pain - Joint	7/53 (13.2%)
Nervous system disorders
Dizziness	9/53 (17%)
Neuropathy: sensory	11/53 (20.8%)
Pain - Head/headache	4/53 (7.5%)
Psychiatric disorders
Insomnia	5/53 (9.4%)
Renal and urinary disorders
Urinary retention (including neurogenic bladder)	3/53 (5.7%)
Reproductive system and breast disorders
Erectile dysfunction	3/53 (5.7%)
Respiratory, thoracic and mediastinal disorders
Cough	3/53 (5.7%)
Dyspnea (shortness of breath)	11/53 (20.8%)
Pleural effusion (non-malignant)	3/53 (5.7%)
Skin and subcutaneous tissue disorders
Rash/desquamation	4/53 (7.5%)
Vascular disorders
Hot flashes/flushes	4/53 (7.5%)
Hypotension	4/53 (7.5%)

Limitations/Caveats

[Not Specified]

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.