A Randomized, Double-blind, Multicenter, Phase 2 Study of a Human Monoclonal Antibody to Human aV Integrins (CNTO 95) in Combination With Docetaxel and Prednisone for the First-Line Treatment of Subjects With Metastatic Hormone Refractory prostate Cancer
- Conditions
- 1/ Metastatic Hormono-resistant Prostate Cancer 2/ Metastatic HRPC10038588
- Registration Number
- NL-OMON31063
- Lead Sponsor
- Janssen-Cilag
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 20
1. Are male >= 18 years of age.
2. Have histologically or cytologically confirmed adenocarcinoma of the prostate.
3. Have radiologic or clinical evidence of metastatic disease.
4. Have progressive hormone-refractory disease after orchiectomy or gonadotropinreleasing
hormone analog and/or antiandrogen treatment within 6 months prior to
the first study agent administration, documented by at least 1 of the following:
a. Transaxial imaging (CT or MRI) tumor progression
b. Rise in 2 consecutive PSA values obtained at least 14 days apart
c. Radionucleotide bone scan with at least 2 new lesions
5. Have an ECOG score <= 2.
6. Have adequate bone marrow, liver, and renal function, defined as follows:
a. Absolute neutrophil count (ANC) >= 1.5 × 109/L
b. Hemoglobin >= 10 g/dL (without transfusion)
c. Platelets >= 100 × 109/L
d. AST and ALT < 2.5 × ULN
e. Alkaline phosphatase < 5 × ULN
f. Total bilirubin within normal limits
g. Creatinine <= 1.5 mg/dL
h. Activated partial thromboplastin time (aPTT) and prothrombin time (PT)
<= 1.5 × ULN
7. Have testosterone < 50 ng/mL for subjects without surgical castration.
Testosterone level will not be documented for subjects who have been surgically
castrated.
8. Have serum PSA >= 5.0 ng/mL.
9. Have a life expectancy > 12 weeks.
10. Have at least 4 weeks from previous major surgery to date of first study agent
administration. Subjects must have recovered or stabilized from previous surgery.
11. Have discontinued flutamide > 4 weeks prior to the first study agent
administration, or have discontinued nilutamide or bicalutamide > 6 weeks prior
to the first study agent administration.
12. Use appropriate contraception (eg, condom) for the duration of the study and for 3 months after the last study treatment.
13. Provide signed and dated informed consent(s) prior to any study-specific
procedures and agree to comply with all protocol-specified procedures.
1. Have known CNS metastases.
2. Had prior systemic nonhormonal therapy for HRPC.
3. Received any investigational drug/agent within 30 days or 5 half-lives, whichever
is longer.
4. Had a prior malignancy (other than prostate cancer) except for adequately treated
superficial bladder cancer, basal cell or squamous cell carcinoma of the skin, or
other cancer for which the subject has been disease-free for >= 5 years.
5. Have known HIV seropositivity or known hepatitis B or C infection.
6. Have planned major surgery during the study.
7. Had prior radiotherapy to > 25% of the marrow-containing skeleton.
8. Have peripheral neuropathy > Grade 1.
9. Have a history of uveitis.
10. Have taken any over-the-counter or herbal treatment for prostate cancer within
4 weeks prior to the first study agent administration.
11. Have a serious concurrent illness or significant cardiac disease characterized by
significant ischemic coronary disease, significant arrhythmias (requiring active
treatment), or congestive heart failure New York Heart Association (>= NYHA II)
or myocardial infarction within the previous 6 months.
12. Have any uncontrolled medical condition, serious infection, or the presence of
clinically significant laboratory abnormalities that places the subject at
unacceptable risk by participating in the study or confounds the ability to interpret
data from the study.
13. Requires hematopoietic growth factors or transfusion of blood products to meet
eligibility criteria.
14. Had prior use of radionucleotide therapy (eg, Strontium89, Samarium).
15. Undergoing concurrent immunotherapy, biotherapy, radiotherapy, investigational
therapy, or steroid therapy other than that included in this protocol (except for
topical or inhaled steroids, or unless clinically indicated [eg, for reactions to IV
contrast, allergic reactions that develop during the study, severe nausea,
vomiting]).
16. Requires concurrent anticoagulation therapy (except for low-dose prophylaxis).
17. Have known hypersensitivity to docetaxel or its components.
18. Have a history of anaphylaxis or severe allergic reaction(s) to human Ig therapy
or polysorbate 80 (formulation components of CNTO 95).
19. Has history of bleeding diathesis.
20. Had recurrent arterial or venous thromboembolism within 6 months preceding
enrollment.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary endpoint is progression-free survival (PFS), defined as the time from<br /><br>the date of randomization until the first documented sign of disease<br /><br>progression (radiographic, clinical, or both) or death due to any cause,<br /><br>whichever occurs sooner.</p><br>
- Secondary Outcome Measures
Name Time Method <p>• Tumor response rate<br /><br>• PSA response rate<br /><br>• Overall survival<br /><br>• Change from baseline in ECOG performance status</p><br>