A phase I/II trial of Cabazitaxel +/- Rhenium-188 HEDP in patients with metastatic castration resistant prostate cancer who progressed on or after a docetaxel containing treatment.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON22536

Enrollment

Registered

2011-12-28

Start date

2012-02-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with castration resistant metastatic prostate cancer to the bone. Ossaal gemetastaseerd prostaatkanker patienten.

Interventions

In the phase I part patients will recieve Rhenium-188 HEDP in combination with a dose finding schedule of Cabazitaxel (20 mg/m2 or 25 mg/m2). The feasible combination will be used in the following ran

Eligibility

Inclusion criteria

Inclusion criteria: 1. mCRPC patients with documented disease progression: A. If measureable: (RECIST) progression; B. 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. 2. Previous treatment with a docetaxel-containing regimen; 3. WHO performance status 0 or 1; 4. Life expectancy of at least 3 months; 5. Age > 18years; 6. Adequate renal function defined as serum creatinin ≤ 1.5 x ULN and/or calculated creatinin clearance 50ml/min; 7. Absolute neutrophil count (ANC) ≥ 1.5 x 109/L, platelet count ≥ 100 x 109/L; 8. Total bilirubin ≤ 1 x ULN, ALT, AST ≤ 2.5 x ULN; 9. Alkaline phosphatase 9 g/dl; Total White cell count >4.0 x 109/l; Platelet count >100 x 109/l; 14. Patients under LH-RH agonists must continue their treatment; 15. Prior hormonal therapy for prostate cancer, resulting in serum testosterone < 50ng/dl.

Exclusion criteria

Exclusion criteria: 1. Previous exposure to Rhenium -188- HEDP within 2 months; 2. Active uncontrolled bacterial, viral or fungal infection; 3. History of another malignancy within the last five years except adequately treated basal cell carcinoma of skin; 4. Organ allografts requiring immunosuppressive therapy; 5. Serious uncontrolled concomitant disease.

Design outcomes

Primary

Measure	Time frame
Progression free survival. Progression is defined according to the recommendations of the Prostate Cancer Clinical Trials Working Group (Scher et al, JCO 2008, 26(7), 1148-59)	—

Secondary

Measure	Time frame
QoL score every (EORTC QlQ 30), pain score (VAS score), skeletal related events, Toxicity (NCI-CTC version 3) every three weeks.	—

Contacts

Public ContactH.J. Bloemendal

Meander Meander Center Utrechtseweg 160

h.bloemendal@meandermc.nl+31 (0)33 8502444

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)