Randomized, Open Label, Multi-Center Study Comparing Cabazitaxel at 25 mg/m2 and at 20 mg/mē in Combination With Prednisone Every 3 Weeks to Docetaxel in Combination With Prednisone in Patients With Metastatic Castration Resistant Prostate Cancer Not Pretreated With Chemotherapy
Treatment Plan
Arm/Group Label
Arm/Group Type
Arm/Group Description
Arm A
Experimental
Cabazitaxel 25 mg/mē intravenously (Day 1) every 3 weeks. Prednisone 10 mg PO daily, from day 1 continuously
Arm B
Experimental
Cabazitaxel 20 mg/mē intravenously (Day 1) every 3 weeks. Prednisone 10 mg PO daily, from day 1 continuously
Arm C
Active Comparator
Docetaxel 75 mg/mē intravenously (Day 1) every 3 weeks. Prednisone 10 mg PO daily, from day 1 continuously
Inclusion criteria:
- Histologically or cytologically-confirmed prostate adenocarcinoma.
- Metastatic disease.
- Progressive disease while receiving hormonal therapy or after surgical castration.
Exclusion criteria:
- Prior chemotherapy for prostate cancer,
- Less than 28 days elapsed from prior treatment with estramustine, radiotherapy or
surgery to the time of randomization. Patients may be on biphosphonates prior to
study entry.
- Prior isotope therapy, whole pelvic radiotherapy, or radiotherapy to > 30% of bone
marrow.
- Adverse events (excluding alopecia and those listed in the specific exclusion
criteria) from any prior anticancer therapy of grade > 1(National Cancer Institute
Common Terminology Criteria [NCI CTCAE] v4.03) at the time of randomization.
- Less than 18 years old.
- Eastern Cooperative Oncology Group (ECOG) performance status > 2.
- History of brain metastases, uncontrolled spinal cord compression, or carcinomatous
meningitis or new evidence of brain or leptomeningeal disease.
- Prior malignancy.
- Participation in another clinical trial and any concurrent treatment with any
investigational drug within 30 days prior to randomization.
- Any of the following within 6 months prior to study enrollment: myocardial
infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft,
NYHA class III or IV congestive heart failure, stroke or transient ischemic attack.
- Any of the following within 3 months prior to randomization: treatment resistant
peptic ulcer disease, erosive esophagitis or gastritis, infectious or inflammatory
bowel disease, diverticulitis, pulmonary embolism, or other uncontrolled
thromboembolic event.
- Acquired immunodeficiency syndrome (AIDS-related illnesses) or known HIV disease
requiring antiretroviral treatment.
- Any severe acute or chronic medical condition which could impair the ability of the
patient to participate to the study or interfere with interpretation of study
results, or patient unable to comply with the study procedures.
- Absence of signed and dated Institutional Review Board (IRB)-approved patient
informed consent form prior to enrollment into the study.
- Patients with reproductive potential who do not agree to use accepted and effective
method of contraception during the study treatment period.
- History of hypersensitivity to docetaxel, or polysorbate 80.
- Inadequate organ and bone marrow function
- Contraindications to the use of corticosteroid treatment.
- Symptomatic peripheral neuropathy grade > 2 (National Cancer Institute Common
Terminology Criteria [NCI CTCAE] v.4.03).
The above information is not intended to contain all considerations relevant to a
patient's potential participation in a clinical trial.
For detailed patient eligibility criteria for this clinical trial, please click here to show/hide
