A Study of CNTO 328 in Patients With Metastatic Hormone-Refractory Prostate Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Centocor, Inc.
ClinicalTrials.gov Identifier:
NCT00401765
First received: November 17, 2006
Last updated: May 23, 2014
Last verified: May 2014
  Purpose

The purpose of this study is to determine the safety of docetaxel and CNTO 328 when given together as a treatment. The second goal of this study is to determine if a combination of docetaxel and CNTO 328 has an effect on prostate cancer.


Condition Intervention Phase
Prostatic Neoplasms
Drug: CNTO 328
Drug: Docetaxel
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Study of a Chimeric Antibody Against Interleukin-6 (CNTO 328) Combined With Docetaxel in Subjects With Metastatic Hormone-Refractory Prostate Cancer

Resource links provided by NLM:


Further study details as provided by Centocor, Inc.:

Primary Outcome Measures:
  • Number of Patients With Adverse Events as a Measure of Safety and Tolerability [ Time Frame: Up to 1 year after the last study medication administration ] [ Designated as safety issue: Yes ]
  • Plasma Concentration of Docetaxel [ Time Frame: predose, post dose (up to 6 hours), and Week 4 (end of treatment visit) ] [ Designated as safety issue: No ]
  • Serum Concentration of Docetaxel in Combination With CNTO 328 [ Time Frame: predose, post dose (up to 6 hours), and up to Week 4 (end of treatment visit) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of Patients with Prostate-Specific Antigen (PSA) Response [ Time Frame: Screening phase (within 4 weeks before administration), every 3 weeks up to 14 cycles or progressive disease, whichever comes first ] [ Designated as safety issue: No ]
    PSA response is defined as number of patients with 50% or more reduction in serum PSA below the baseline value.

  • Number of Patients With PSA Reduced Within 3 Months [ Time Frame: Screening phase (within 4 weeks before administration), every 3 weeks up to 14 cycles or progressive disease, whichever comes first ] [ Designated as safety issue: No ]
    PSA reduced within 3 months is defined as number of patients with 50% or more reduction in serum PSA below the screening value within 3 months after the first administration of study medication.

  • PSA Progression in Patients [ Time Frame: Screening phase (within 4 weeks before administration), every 3 weeks up to 14 cycles or progressive disease, whichever comes first ] [ Designated as safety issue: No ]
  • Duration of Tumor Response [ Time Frame: Screening phase (within 4 weeks before administration); every 3 weeks up to 14 cycles; and every 3 months up to 1 year after the last study medication administration ] [ Designated as safety issue: No ]
    Duration of tumor response is defines as the time from first documented evidence of response (complete response [Total disappearance of a disease] or partial response [50% or more decrease from baseline in the sum of products of perpendicular diameters of all measurable lesions]) to documented disease progression or death, whichever is earlier.

  • Duration of PSA response [ Time Frame: Screening phase (within 4 weeks before administration), every 3 weeks up to 14 cycles or progressive disease, whichever comes first ] [ Designated as safety issue: No ]
    Duration of PSA response is defined as the time from first observation of serum PSA response until PSA progression, disease progression, or death, if sooner.

  • Objective Tumor Response [ Time Frame: Screening phase (within 4 weeks before administration); every 3 weeks up to 14 cycles; and every 3 months up to 1 year after the last study medication administration ] [ Designated as safety issue: No ]
    Tumor response will be evaluated as Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD). CR is defined as complete disappearance of all measurable and evaluable disease; PR is defined as 50 percentage or more decrease from baseline in the sum of products of diameters of all measurable lesions; SD is defined as 25 percentage or less decrease from baseline in the sum of products of diameters of all measurable lesions; and PD is defined as 25 percentage or more increase in the sum of products of diameters of measurable lesions over the smallest sum observed, or reappearance of any lesion which had disappeared, or appearance of any new lesion, or failure to return for evaluation due to death or deteriorating condition.

  • Pharmacodynamics of CNTO 328 administered in combination with docetaxel [ Time Frame: predose, post dose (up to Day 14), and up to Week 4 (end of treatment visit) ] [ Designated as safety issue: No ]
    Pharmacodymanics parameters: C reactive protein, Interleukin-6 (IL-6), serum amyloid-A, serum prostate-specific antigen, IL-6 bioactivity, vascular endothelial growth factor, fibroblast growth factor, and circulating tumor cells will be measured.

  • Serum concentration of CNTO 328 [ Time Frame: predose, post dose (up to Day 14), and up to Week 4 (end of treatment visit) ] [ Designated as safety issue: No ]
  • Serum concentration of CNTO 328 in combination with docetaxel [ Time Frame: predose, post dose (up to Day 14), and up to Week 4 (end of treatment visit) ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: September 2005
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort 1A (Docetaxel and CNTO 328)
In cohort 1A, 75 mg/m2 docetaxel will be administered in run-in phase and 75 mg/m2 docetaxel every 3 weeks and 6 mg/kg CNTO 328 every 2 weeks will be administered in the treatment phase.
Drug: CNTO 328
Patients will receive 6 mg/kg CNTO 328 in treatment phase of cohort 1A and cohort 1B; 9 mg/kg CNTO 328 in treatment phase of cohort 2; and 12 mg/kg CNTO 328 in treatment phase of cohort 3.
Drug: Docetaxel
Patients will receive 75 mg/m2 docetaxel in run-in phase of cohort 1A, cohort 2, and cohort 3; and in treatment phase of cohort 1A, cohort 1B, cohort 2, and cohort 3.
Experimental: Cohort 1B (Docetaxel and CNTO 328)
In cohort 1B, 6 mg/kg CNTO 328 will be administered in run-in phase and 75 mg/m2 docetaxel will be administered every 3 weeks plus 6 mg/kg CNTO 328 will be administered every 2 weeks in the treatment phase.
Drug: CNTO 328
Patients will receive 6 mg/kg CNTO 328 in treatment phase of cohort 1A and cohort 1B; 9 mg/kg CNTO 328 in treatment phase of cohort 2; and 12 mg/kg CNTO 328 in treatment phase of cohort 3.
Drug: Docetaxel
Patients will receive 75 mg/m2 docetaxel in run-in phase of cohort 1A, cohort 2, and cohort 3; and in treatment phase of cohort 1A, cohort 1B, cohort 2, and cohort 3.
Experimental: Cohort 2 (Docetaxel and CNTO 328)
In cohort 2, 75 mg/m2 docetaxel will be administered in run-in phase and 75 mg/m2 docetaxel plus 9 mg/kg CNTO 328 will be administered every 3 weeks in treatment phase.
Drug: CNTO 328
Patients will receive 6 mg/kg CNTO 328 in treatment phase of cohort 1A and cohort 1B; 9 mg/kg CNTO 328 in treatment phase of cohort 2; and 12 mg/kg CNTO 328 in treatment phase of cohort 3.
Drug: Docetaxel
Patients will receive 75 mg/m2 docetaxel in run-in phase of cohort 1A, cohort 2, and cohort 3; and in treatment phase of cohort 1A, cohort 1B, cohort 2, and cohort 3.
Experimental: Cohort 3 (Doctaxel and CNTO 328)
In cohort 3, 75 mg/m2 docetaxel will be administered in the run-in phase and 75 mg/m2 docetaxel plus 12 mg/kg CNTO 328 will be administered every 3 weeks in treatment phase.
Drug: CNTO 328
Patients will receive 6 mg/kg CNTO 328 in treatment phase of cohort 1A and cohort 1B; 9 mg/kg CNTO 328 in treatment phase of cohort 2; and 12 mg/kg CNTO 328 in treatment phase of cohort 3.
Drug: Docetaxel
Patients will receive 75 mg/m2 docetaxel in run-in phase of cohort 1A, cohort 2, and cohort 3; and in treatment phase of cohort 1A, cohort 1B, cohort 2, and cohort 3.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically or cytologically confirmed adenocarcinoma of the prostate
  • Radiologically documented metastatic disease
  • No prior systemic chemotherapy for metastatic hormone refractory prostate cancer
  • Progressive hormone-refractory disease after orchiectomy or gonadotropin-releasing hormone analog and/or anti-androgen treatment within 12 months of screening based on 1 of the following: Transaxial imaging tumor progression, Rise in 2 consecutive prostate-specifec antigen (PSA) values obtained at least 7 days apart or Radionucleotide bone scan progression
  • Karnofsky performance status of greater than or equal to 60

Exclusion Criteria:

  • Prostate cancer that does not express serum PSA or is less than 5.0 ng/mL at screening
  • Received any investigational drug/agent within 30 days or 5 half-lives, whichever is longer
  • Prior malignancy (other than prostate cancer) except adequately treated basal cell or squamous cell carcinoma of the skin or other cancer for which the subject has been disease-free for greater than or equal to 3 years
  • Known central nervous system metastases
  • Received any over-the-counter or herbal treatment for prostate cancer (eg, PC SPES [an herbal refined powder]) within 4 weeks prior to screening.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00401765

Locations
United States, Maryland
Baltimore, Maryland, United States
United States, New York
New York, New York, United States
United States, North Carolina
Chapel Hill, North Carolina, United States
United States, Pennsylvania
Philadelphia, Pennsylvania, United States
United States, Tennessee
Nashville, Tennessee, United States
Sponsors and Collaborators
Centocor, Inc.
Investigators
Study Director: Centocor, Inc. Clinical Trial Centocor, Inc.
  More Information

Additional Information:
No publications provided

Responsible Party: Centocor, Inc.
ClinicalTrials.gov Identifier: NCT00401765     History of Changes
Other Study ID Numbers: CR005275, C0328T04
Study First Received: November 17, 2006
Last Updated: May 23, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Centocor, Inc.:
Prostatic neoplasm
intravenous
docetaxel
monoclonal antibody

Additional relevant MeSH terms:
Neoplasms
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms
Docetaxel
Antimitotic Agents
Antineoplastic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on October 23, 2014