Advanced Prostate Cancer MedDRA version: 14.0 Level: LLT Classification code 10062904 Term: Hormone-refractory prostate cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 14.0 Level: PT Classification code 10036920 Term: Prostate cancer stage IV System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: JEVTANA
Pharmaceutical Form: Solution for infusion
CAS Number: 183133-96-2
Other descriptive name: CABAZITAXEL
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
C
Sponsors
SOGUG - Spanish Oncology Genitourinary Group
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Patients who have given written informed consent. 2. Age ? 18 years. 3. ECOG 0-2. 4. Patients with a histologic or cytologic diagnosis of advanced prostate cancer (any Gleason grade). 5. Previous and ongoing castration by orchiectomy or LHRH agonists. Antiandrogen must be discontinued prior to study start. 6. Disease progression, clinically or radiologically documented, during or after treatment with docetaxel, with a minimum cumulative dose of 225 mg/m2. 7. ?Unfit? patients defined as patients who satisfy at least one of the following criteria: - Age ? 75 years - Dose reduction due to febrile neutropenia during the previous treatment with docetaxel - Radiation therapy affecting more than 25% of bone marrow reserve - ECOG 2 8. Documented metastatic disease and progressing after docetaxel treatment. Progression criteria is considered any of the following three or more than one at once: - Progressive elevation of PSA measured in three successive determinations one week difference between them at least; - Should be considered progression of measurable disease by RECIST criteria; - Bone progression as evidenced by the appearance of two or more new lesions on bone scan. 9. Patients who have received a maximum of two prior chemotherapy for metastatic disease. 10. Prior anticancer therapy should have been interrupted 28 days before the start of study treatment (the patient may have continued treatment with prednisone 5 mg bid). 11. Adequate blood, liver and kidney function: - Hemoglobin > 9.0 g/dl - ANC > 1.5 x 10E9/L - Platelets > 100 x 10E9/L - AST/SGOT and ALT/SGPT =65 years) yes F.1.3.1 Number of subjects for this age range 34
Exclusion criteria
Exclusion criteria: 1. Patients who received radiation therapy that exceeded 40% of the bone marrow reserve or that ended within the last 3 weeks prior to inclusion. 2. If being treated with radiation therapy, should be completed before the three weeks prior to initiation of treatment research. 3. Previous treatment with two or more chemotherapy regimens for metastatic disease. A new line of treatment is also when a patient receives again docetaxel after clinical, radiological or PSA progression to a prior regimen with docetaxel. 4. Previous treatment with chemotherapy or surgery in the last 4 weeks. 5. Peripheral neuropathy or stomatitis ? 2 (National Cancer Institute Common Terminology Criteria - NCI CTCAE vs. 4.03). 6. Any other type of cancer in the last 5 years, except for basal cell skin carcinoma. 7. Cerebral or leptomeningeal metastasis. 8. Myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass, congestive heart failure (NYHA class III or IV), stroke or transitory ischemic episodes. 9. Patients who present any severe or uncontrolled medical condition (including uncontrolled diabetes mellitus) or any other condition that may affect the patient?s participation and study compliance. 10. Previous treatment with cabazitaxel. 11. Known hypersensitivity (? grade 3)to cabazitaxel, polysorbate 80, prednisone or prednisolone, or docetaxel or paclitaxel. 12. Known history of active infection that requires systemic antibiotic or antifungal treatment. 13. Patients who are receiving or expect to receive treatment with strong inhibitors or strong inducers of cytochrome CYP450 3A4/5 (a one week wash-out period is necessary for patients who are already on these treatments) (see Annexes 5 and 6). 14. Patients being treated with any investigational product.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluate the activity of the weekly administration of cabazitaxel as time to PSA progression according to the PCCTWG II criteria.;Primary end point(s): Time to PSA progression, according to the PCCTWG II criteria.;Timepoint(s) of evaluation of this end point: Until PSA progression;Secondary Objective: Evaluate the rate of biochemical response by means of PSA determination and defined as the percentage of patients with a reduction of 30%, 50% and 80% with respect to baseline. Evaluate the overall response rate of the disease according to modified RECIST criteria. Evaluate overall survival. Evaluate the safety and tolerability profile of cabazitaxel. Determine the pain response in patients with stable pain at baseline by means of the MPQ-sf (McGill Pain Questionnaire - short form). Evaluate the correlation between Charlson co-morbidity index and the ADL/IADL dependence indexes in predicting survival and toxicity in patients with hormone-refractory prostate cancer previously treated with docetaxel. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1-Evaluate the rate of biochemical response by PSA determination defined as the percentage of patients with 30%, 50% and 80% reduction respect to baseline. 2-The proportion of patients with an objective tumoral response according to modified RECIST criteria. The response in measurable soft tissue lesions is determined by RECIST criteria. Progression of bone metastasis diagnosed by bone scan is defined by the appearance of two or more new confirmed lesions one month later. 3-Overall survival is calculated since the date of patient study enrolment till death. 4-Evaluate the safety and tolerability profile of cabazitaxel. 5-Determine the pain response in patients with stable pain at baseline by means of the McGill-Melzack MPQ-sf questionnaire, defined as >= 2 points with respect to baseline on the PPI scale without increase in the analgesic scale, or with a decrease of >= 50% in the use of analgesics without an increase in pain that is maintained for more than 3 weeks. 6-Evaluation of the correlation of the Charlson co-morbidity index and ADL/IADL dependency indexes with survival and toxicity in patients with hormone-refractory prostate cancer previously treated with docetaxel.;Timepoint(s) of evaluation of this end point: 1-Until PSA progression 2-Until end of treatment 3-Until death 4-Until end of treatment 5-Until end of treatment 6-Until death | — |
Countries
Spain
Contacts
Public ContactJuan Luis Sanz
APICES SOLUCIONES, S.L.
Outcome results
None listed