Subjects affected by metastatic castration refractory prostate cancer progressed or intolerant to a previous docetaxel-based chemotherapy.
Conditions
Interventions
Trade Name: JEVTANA*EV 1FL 60MG 1,5ML+1FL
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: CABAZITAXEL
CAS Number: 183133-96-2
Concentration unit: mg/ml milligram(s)/mil
Sponsors
AZIENDA UNIVERSITARIA POLICLINICO UMBERTO I DI ROMA
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Diagnosis of histologically or cytologically proven prostate adenocarcinoma that is resistant to hormone therapy and previously treated with a docetaxel-containing regimen. 2. Age =18 years old. 3. Patient must have either radiologically measurable or non-measurable disease. 4. 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. 5. Life expectancy > 6 months. 6. 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). 7. Written informed consent. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 15
Exclusion criteria
Exclusion criteria: 1. Previous treatment with cabazitaxel. 2. 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. 3. 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. 4. Prior surgery, radiation, chemotherapy, or other anti-cancer therapy within 4 weeks prior to enrollment in the study. 5. 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. 6. Participation in another clinical trial and any concurrent treatment with any investigational drug within 30 days prior to randomization. 7. Known brain or leptomeningeal involvement. 8. Other concurrent serious illness or medical conditions. 9. Uncontrolled cardiac arrhythmias, angina pectoris, and/or hypertension. History of congestive heart failure or myocardial infarction within last 6 months is also not allowed. 10. 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. 11. Absence of signed and dated Institutional Review Board (IRB)-approved patient informed consent form prior to enrollment into the study. 12. 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. 13. Inadequate organ and bone marrow function. 14. Contraindications to the use of corticosteroid treatment. 15. Symptomatic peripheral neuropathy grade > 2 (National Cancer Institute Common Terminology Criteria [NCI CTCAE] v.4.03).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The incidence of grade 3 or 4 neutropenia in phase III trial was 83%, in this study patients were treated with cabazitaxel 25 mg/mq every three weeks. We hypothesized that treatment with cabazitaxel at dosage of 15 mg/mq every two weeks may reduce the incidence of grade 3 or 4 neutropenia from 83% to 50%.;Secondary Objective: - Safety and tolerability - Progression-Free Survival (PFS) - Overall survival (OS) - PSA response rate (PSA-RR) - Explore circulating tumor cells (CTC) in whole blood and their associations with efficacy endpoints - Evaluation of patient-reported outcomes (PRO), including pain intensity (BPI-sf worst pain), and health state utilities (EQ-5D) will be examined.;Primary end point(s): The incidence of grade 3 or 4 neutropenia in phase III trial was 83%, in this study patients were treated with cabazitaxel 25 mg/mq every three weeks. We hypothesized that treatment with cabazitaxel at dosage of 15 mg/mq every two weeks may reduce the incidence of grade 3 or 4 neutropenia from 83% to 50%.;Timepoint(s) of evaluation of this end point: 2 years. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Safety and tolerability - Progression-Free Survival (PFS) - Overall survival (OS) - PSA response rate (PSA-RR) - Explore circulating tumor cells (CTC) in whole blood and their associations with efficacy endpoints - Evaluation of patient-reported outcomes (PRO), including pain intensity (BPI-sf worst pain), and health state utilities (EQ-5D) will be examined.;Timepoint(s) of evaluation of this end point: 3 anni. | — |
Countries
Italy
Contacts
Public ContactONCOLOGIA B
DIP. DI SCIENZE RADIOLOGICHE, ONCOLOGICHE ED ANATOMO PATOLOGICHE - UNIVERSITA' LA SAPIENZA - AZ. POLICLINICO UMBERTO I
Outcome results
None listed