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

Prostate Cancer Clinical Trial

Official title:

A Phase II Study of CNTO 328, A Monoclonal Antibody Against Interleukin-6 (IL-6), in Patients With Hormone Refractory Prostate Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00433446
• Other study ID #: CDR0000526555
• Secondary ID: U10CA032102S0354
• Status: Completed
• Phase: Phase 2
• First received: February 8, 2007
• Last updated: January 2, 2013
• Start date: April 2007
• Est. completion date: July 2011

Study information

• Verified date: January 2013
• Source: Southwest Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: July 2011
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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)

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Biological:
• CNTO 328

Locations

Country	Name	City	State
United States	AnMed Cancer Center	Anderson	South Carolina
United States	CCOP - Michigan Cancer Research Consortium	Ann Arbor	Michigan
United States	Saint Joseph Mercy Cancer Center	Ann Arbor	Michigan
United States	University of Michigan Comprehensive Cancer Center	Ann Arbor	Michigan
United States	Regional Medical Center	Anniston	Alabama
United States	Mary Bird Perkins Cancer Center - Baton Rouge	Baton Rouge	Louisiana
United States	Pennington Cancer Center at Baton Rouge General	Baton Rouge	Louisiana
United States	Battle Creek Health System Cancer Care Center	Battle Creek	Michigan
United States	St. Joseph Cancer Center	Bellingham	Washington
United States	Alta Bates Summit Comprehensive Cancer Center	Berkeley	California
United States	Mecosta County Medical Center	Big Rapids	Michigan
United States	Billings Clinic - Downtown	Billings	Montana
United States	CCOP - Montana Cancer Consortium	Billings	Montana
United States	Hematology-Oncology Centers of the Northern Rockies - Billings	Billings	Montana
United States	Northern Rockies Radiation Oncology Center	Billings	Montana
United States	St. Vincent Healthcare Cancer Care Services	Billings	Montana
United States	Bozeman Deaconess Cancer Center	Bozeman	Montana
United States	Olympic Hematology and Oncology	Bremerton	Washington
United States	Peninsula Medical Center	Burlingame	California
United States	St. James Healthcare Cancer Care	Butte	Montana
United States	Cancer Center of Kansas, PA - Chanute	Chanute	Kansas
United States	Presbyterian Cancer Center at Presbyterian Hospital	Charlotte	North Carolina
United States	Danville Regional Medical Center	Danville	Virginia
United States	Genesis Regional Cancer Center at Genesis Medical Center	Davenport	Iowa
United States	Oakwood Cancer Center at Oakwood Hospital and Medical Center	Dearborn	Michigan
United States	Cancer Center of Kansas, PA - Dodge City	Dodge City	Kansas
United States	Cancer Center of Kansas, PA - El Dorado	El Dorado	Kansas
United States	Genesys Hurley Cancer Institute	Flint	Michigan
United States	Hurley Medical Center	Flint	Michigan
United States	Poudre Valley Hospital	Fort Collins	Colorado
United States	Glendale Memorial Hospital Comprehensive Cancer Center	Glendale	California
United States	Wayne Memorial Hospital, Incorporated	Goldsboro	North Carolina
United States	Butterworth Hospital at Spectrum Health	Grand Rapids	Michigan
United States	CCOP - Grand Rapids	Grand Rapids	Michigan
United States	Lacks Cancer Center at Saint Mary's Health Care	Grand Rapids	Michigan
United States	Metro Health Hospital	Grand Rapids	Michigan
United States	Big Sky Oncology	Great Falls	Montana
United States	Great Falls Clinic - Main Facility	Great Falls	Montana
United States	Sletten Cancer Institute at Benefis Healthcare	Great Falls	Montana
United States	Marin Cancer Institute at Marin General Hospital	Greenbrae	California
United States	Sutter Health - Western Division Cancer Research Group	Greenbrae	California
United States	Legacy Mount Hood Medical Center	Gresham	Oregon
United States	Van Elslander Cancer Center at St. John Hospital and Medical Center	Grosse Pointe Woods	Michigan
United States	St. Peter's Hospital	Helena	Montana
United States	Pardee Memorial Hospital	Hendersonville	North Carolina
United States	Veterans Affairs Medical Center - Hines	Hines	Illinois
United States	Holland Community Hospital	Holland	Michigan
United States	Foote Memorial Hospital	Jackson	Michigan
United States	University of Mississippi Cancer Clinic	Jackson	Mississippi
United States	Glacier Oncology, PLLC	Kalispell	Montana
United States	Kalispell Medical Oncology at KRMC	Kalispell	Montana
United States	Kalispell Regional Medical Center	Kalispell	Montana
United States	Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center	Kansas City	Kansas
United States	Good Samaritan Cancer Center at Good Samaritan Hospital	Kearney	Nebraska
United States	Columbia Basin Hematology	Kennewick	Washington
United States	Cancer Center of Kansas, PA - Kingman	Kingman	Kansas
United States	Sparrow Regional Cancer Center	Lansing	Michigan
United States	Southwest Medical Center	Liberal	Kansas
United States	St. Mary Mercy Hospital	Livonia	Michigan
United States	USC/Norris Comprehensive Cancer Center and Hospital	Los Angeles	California
United States	Ravenel Oncology Center at Memorial Hospital of Martinsville and Henry County	Martinsville	Virginia
United States	Tucker Center for Cancer Care at Orange Regional Medical Center	Middletown	New York
United States	Providence Milwaukie Hospital	Milwaukie	Oregon
United States	Community Medical Center	Missoula	Montana
United States	Guardian Oncology and Center for Wellness	Missoula	Montana
United States	Montana Cancer Center at St. Patrick Hospital and Health Sciences Center	Missoula	Montana
United States	Montana Cancer Specialists at Montana Cancer Center	Missoula	Montana
United States	Ted B. Wahby Cancer Center at Mount Clemens General Hospital	Mount Clemens	Michigan
United States	Hackley Hospital	Muskegon	Michigan
United States	MBCCOP - LSU Health Sciences Center	New Orleans	Louisiana
United States	Medical Center of Louisiana - New Orleans	New Orleans	Louisiana
United States	Cancer Center of Kansas, PA - Newton	Newton	Kansas
United States	M.D. Anderson Cancer Center at Orlando	Orlando	Florida
United States	Cancer Center of Kansas, PA - Parsons	Parsons	Kansas
United States	St. Joseph Mercy Oakland	Pontiac	Michigan
United States	Mercy Regional Cancer Center at Mercy Hospital	Port Huron	Michigan
United States	Adventist Medical Center	Portland	Oregon
United States	CCOP - Columbia River Oncology Program	Portland	Oregon
United States	Legacy Emanuel Hospital and Health Center and Children's Hospital	Portland	Oregon
United States	Legacy Good Samaritan Hospital & Comprehensive Cancer Center	Portland	Oregon
United States	Providence Cancer Center at Providence Portland Medical Center	Portland	Oregon
United States	Providence St. Vincent Medical Center	Portland	Oregon
United States	Cancer Center of Kansas, PA - Pratt	Pratt	Kansas
United States	Interlakes Oncology/Hematology PC	Rochester	New York
United States	James P. Wilmot Cancer Center at University of Rochester Medical Center	Rochester	New York
United States	Rutherford Hospital	Rutherfordton	North Carolina
United States	University of California Davis Cancer Center	Sacramento	California
United States	Seton Cancer Institute at Saint Mary's - Saginaw	Saginaw	Michigan
United States	Cancer Center of Kansas, PA - Salina	Salina	Kansas
United States	Cancer Therapy and Research Center	San Antonio	Texas
United States	University Hospital - San Antonio	San Antonio	Texas
United States	University of Texas Health Science Center at San Antonio	San Antonio	Texas
United States	Veterans Affairs Medical Center - San Antonio (Murphy)	San Antonio	Texas
United States	California Pacific Medical Center - California Campus	San Francisco	California
United States	Fred Hutchinson Cancer Research Center	Seattle	Washington
United States	Group Health Central Hospital	Seattle	Washington
United States	Harborview Medical Center	Seattle	Washington
United States	Minor and James Medical, PLLC	Seattle	Washington
United States	Polyclinic First Hill	Seattle	Washington
United States	Swedish Cancer Institute at Swedish Medical Center - First Hill Campus	Seattle	Washington
United States	University Cancer Center at University of Washington Medical Center	Seattle	Washington
United States	Welch Cancer Center at Sheridan Memorial Hospital	Sheridan	Wyoming
United States	CCOP - Upstate Carolina	Spartanburg	South Carolina
United States	Gibbs Regional Cancer Center at Spartanburg Regional Medical Center	Spartanburg	South Carolina
United States	Cancer Care Northwest - Spokane South	Spokane	Washington
United States	Highlands Oncology Group - Springdale	Springdale	Arkansas
United States	CCOP - Cancer Research for the Ozarks	Springfield	Missouri
United States	Hulston Cancer Center at Cox Medical Center South	Springfield	Missouri
United States	St. John's Regional Health Center	Springfield	Missouri
United States	Munson Medical Center	Traverse City	Michigan
United States	Legacy Meridian Park Hospital	Tualatin	Oregon
United States	Sutter Solano Medical Center	Vallejo	California
United States	Southwest Washington Medical Center Cancer Center	Vancouver	Washington
United States	St. John Macomb Hospital	Warren	Michigan
United States	Cancer Center of Kansas, PA - Wellington	Wellington	Kansas
United States	Wenatchee Valley Medical Center	Wenatchee	Washington
United States	Associates in Womens Health, PA - North Review	Wichita	Kansas
United States	Cancer Center of Kansas, PA - Medical Arts Tower	Wichita	Kansas
United States	Cancer Center of Kansas, PA - Wichita	Wichita	Kansas
United States	CCOP - Wichita	Wichita	Kansas
United States	Via Christi Cancer Center at Via Christi Regional Medical Center	Wichita	Kansas
United States	Cancer Center of Kansas, PA - Winfield	Winfield	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
Southwest Oncology Group	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Dorff TB, Goldman B, Pinski JK, Mack PC, Lara PN Jr, Van Veldhuizen PJ Jr, Quinn DI, Vogelzang NJ, Thompson IM Jr, Hussain MH. Clinical and correlative results of SWOG S0354: a phase II trial of CNTO328 (siltuximab), a monoclonal antibody against interleu — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Confirmed Prostate-Specific Antigen (PSA) Response	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.	Assessed every 3 cycles (1 cycle = 14 days) until progression	No
Secondary	Progression-free Survival (PFS)	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.	Assessed every 3 cycles (1 cycle = 14 days) until progression	No
Secondary	Overall Survival (OS)	Measured from date of registration to date of death due to any cause or last contact	0-3 yeas after registration	No
Secondary	Objective Response (Confirmed and Unconfirmed Complete and Partial Response) Among Those Patients With Measurable Disease	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.	Assessed every 3 cycles (1 cycle= 14 days) of treatment until progression	No
Secondary	Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug	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.	Patients were assessed for adverse events after every cycle (1 cycle = 14 days) of protocol treatment	Yes