Prostatic Neoplasms Clinical Trial
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
Verified date | May 2014 |
Source | Centocor, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 40 |
Est. completion date | November 2009 |
Est. primary completion date | November 2009 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility |
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. |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Centocor, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Patients With Adverse Events as a Measure of Safety and Tolerability | Up to 1 year after the last study medication administration | Yes | |
Primary | Plasma Concentration of Docetaxel | predose, post dose (up to 6 hours), and Week 4 (end of treatment visit) | No | |
Primary | Serum Concentration of Docetaxel in Combination With CNTO 328 | predose, post dose (up to 6 hours), and up to Week 4 (end of treatment visit) | No | |
Secondary | Number of Patients with Prostate-Specific Antigen (PSA) Response | PSA response is defined as number of patients with 50% or more reduction in serum PSA below the baseline value. | Screening phase (within 4 weeks before administration), every 3 weeks up to 14 cycles or progressive disease, whichever comes first | No |
Secondary | Number of Patients With PSA Reduced Within 3 Months | 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. | Screening phase (within 4 weeks before administration), every 3 weeks up to 14 cycles or progressive disease, whichever comes first | No |
Secondary | PSA Progression in Patients | Screening phase (within 4 weeks before administration), every 3 weeks up to 14 cycles or progressive disease, whichever comes first | No | |
Secondary | Duration of Tumor Response | 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. | 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 | No |
Secondary | Duration of PSA response | 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. | Screening phase (within 4 weeks before administration), every 3 weeks up to 14 cycles or progressive disease, whichever comes first | No |
Secondary | Objective Tumor Response | 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. | 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 | No |
Secondary | Pharmacodynamics of CNTO 328 administered in combination with docetaxel | 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. | predose, post dose (up to Day 14), and up to Week 4 (end of treatment visit) | No |
Secondary | Serum concentration of CNTO 328 | predose, post dose (up to Day 14), and up to Week 4 (end of treatment visit) | No | |
Secondary | Serum concentration of CNTO 328 in combination with docetaxel | predose, post dose (up to Day 14), and up to Week 4 (end of treatment visit) | No |
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