Metastatic prostate cancer/bone metastases
Conditions
Interventions
Trade Name: Cabazitaxel
Product Name: Cabazitaxel
Product Code: XRP6258
Pharmaceutical Form: Infusion
INN or Proposed INN: Jevtana
CAS Number: 183133-96-2
Current Sponsor code: XRP6258
Other descripti
Sponsors
None listed
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: • mCRPC patients with documented disease progression; - If measureable: (RECIST) progression - If non-measurable: documented rising PSA levels (at least 2 consecutive rises in PSA over a reference value taken at least 1 week apart) or appearance of new lesion • Previous treatment with a docetaxel-containing regimen • WHO performance status 0 or 1. • Life expectancy of at least 3 months. • Age > 18years. • Adequate renal function defined as serum creatinin = 1.5 x ULN and/or calculated creatinin clearance 50ml/min • Absolute neutrophil count (ANC) = 1.5 x 109/L, platelet count = 100 x 109/L • Total bilirubin = 1 x ULN, ALT, AST = 2.5 x ULN • Alkaline phosphatase 9 g/dl; Total White cell count >4.0 x 109/l; Platelet count >100 x 109/l. • Patients under LH-RH agonists must continue their treatment. • Prior hormonal therapy for prostate cancer, resulting in serum testosterone =65 years) yes F.1.3.1 Number of subjects for this age range 65
Exclusion criteria
Exclusion criteria: • Previous exposure to combined Rhenium -188- HEDP and docetaxel treatment. • Active uncontrolled bacterial, viral or fungal infection. • History of another malignancy within the last five years except adequately treated basal cell carcinoma of skin. • Organ allografts requiring immunosuppressive therapy. • Serious uncontrolled concomitant disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: Secondary objectives: Evaluate time to progression, clinical benefit response and toxicity ;Timepoint(s) of evaluation of this end point: end of studie;Main Objective: Primary objectives: To establish a safe and effective dosing schedule for repeated administration of Rhenium-188 HEDP combined with cabazitaxel in order to proceed with a Randomized Phase 2 trial designed to determine the clinical value of Rhenium-188 HEDP/cabazitaxel using overall survival as the primary endpoint. Patients included in the phase1 part with the dose schedule selected for the phase 2 part will be integrated in the final phase 2 analysis. ;Primary end point(s): Phase I: Dose Limiting Toxicity (DLT) is defined as any grade 4 toxicity lasting >7 days, or any grade 3 toxicity which does not recover within 10 days. If a DLT occurs in 1 of the 3 patients in a particular treatment level, the group will be expanded to 6 patients. If 2 or more of the group experience a DLT, we will treat the next 3 patients at the previous dose level (i.e. If DLT in >2/6 at dose level 2, 3 patients will be treated at dose level 1. If none of the group of 3 or <1/6 experience DLT, 3 patients will be treated at the next dose level. The final group of 3 patients will be treated at a planned dose of 6 cycles of cabazitaxel 25mg/m2 and 2 cycles of Rhenium-188 HEDP (40 MBq/kg). Phase II: Efficacy Parameters TTP (time to progression ) will be the primary efficacy endpoint. Furthermore, PSA, and clinical benefit response (Skeletal Related Events, Qol, Pain and Palliative Medication). . Safety Parameters: Adverse events and clinical laboratory parameters including hematology (complete blood counts including differential and platelets), survival. NCI toxicity criteria will be followed. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): toxicity and progression of disease;Timepoint(s) of evaluation of this end point: during the study | — |
Countries
Netherlands
Outcome results
None listed