Randomized, Open Label Multi-Center Study Comparing Cabazitaxel at 20 mg/mē and at 25 mg/mē Every 3 Weeks in Combination With Prednisone for the Treatment of Metastatic Castration Resistant Prostate Cancer Previously Treated With a Docetaxel-Containing Regimen
Treatment Plan
Arm/Group Label
Arm/Group Type
Arm/Group Description
Arm A
Experimental
cabazitaxel 20 mg/mē intravenously (Day 1) every 3 weeks Prednisone or prednisolone (if prednisone is not commercially available), 10 mg PO daily, from day 1 continuously
Arm B
Experimental
cabazitaxel 25 mg/mē intravenously (Day 1) every 3 weeks Prednisone or prednisolone (if prednisone is not commercially available), 10 mg PO daily, from day 1 continuously
Intervention(s)
cabazitaxel (XRP6258), Prednisone,
Patient eligibility
Inclusion criteria:
- Diagnosis of histologically or cytologically proven prostate adenocarcinoma, that is
resistant to hormone therapy and previously treated with a docetaxel-containing
regimen.
- Patient must have either measurable or non-measurable disease.
- Received prior castration by orchiectomy and/or Luteinizing Hormone-Releasing Hormone
(LH-RH) agonist with or without antiandrogen, antiandrogen withdrawal, monotherapy
with estramustine, or other hormonal agents.
- Life expectancy > 6 months.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 - 2 (ie, patient
must be ambulatory, capable of all self-care, and up and about more than 50% of
waking hours).
- Age >=18 years old.
Exclusion criteria:
- Previous treatment with mitoxantrone or cabazitaxel.
- Prior isotope therapy or radiotherapy to >= 30% of bone marrow. In case of prior
isotope therapy 12 weeks must have elapsed prior to first study drug administration.
- 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.
- Prior surgery, radiation, chemotherapy, or other anti-cancer therapy within 4 weeks
prior to enrollment in the study.
- Prior malignancy. Adequately treated basal cell or squamous cell skin or superficial
(pTis, pTa, and pT1) bladder cancer are allowed, as well as any other cancer for
which chemotherapy has been completed >= 5 years ago and from which the patient has
been disease-free for >= 5 years.
- Participation in another clinical trial and any concurrent treatment with any
investigational drug within 30 days prior to randomization.
- Known brain or leptomeningeal involvement.
- Other concurrent serious illness or medical conditions
- Uncontrolled cardiac arrhythmias, angina pectoris, and/or hypertension. History of
congestive heart failure or myocardial infarction within last 6 months is also not
allowed.
- Any severe acute or chronic medical condition which could impair the ability of the
patient to participate to the study or to comply with the study procedures or
interfere with interpretation of study results.
- 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. The definition of
"effective method of contraception" will be based on the Investigator's judgment.
Patients' Partners of childbearing potential (unless surgically sterile, post
menopausal or for another reason have no chance of becoming pregnant) not protected
by highly effective contraceptive method of birth control as defined for
contraception in the Informed Consent Form and /or in a local protocol addendum.
- 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
