No registrations found.
ID
Source
Brief title
Health condition
Patients with castration resistant metastatic prostate cancer to the bone.
Ossaal gemetastaseerd prostaatkanker patienten.
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
QoL score every (EORTC QlQ 30), pain score (VAS score), skeletal related events, Toxicity (NCI-CTC version 3) every three weeks.
Background summary
Prostate cancer is very common and often leads to bone metastases. Although initially most patients respond to androgen deprivation, after approximately 18 months the cancer will become hormone refractory leading to progressive disease. Since 2004 docetaxel became standard chemotherapy for men with metastatic CRPC leading to survival benefit. Several trials have shown evidence of the disease modifying potential of bone seeking radionuclides. Recent studies have shown an improvement of survival and quality of life when Rhenium-186 HEDP was given in high dosage or repeatedly. Recently results of our dose finding trial (XRP6976J/6213) shows that combined therapy with docetaxel and Rhenium-186 HEDP is generally well tolerated in patients with metastatic bone disease from prostate cancer. A phase II study (DOCET_L_04935) will be conducted using 3 cycles of docetaxel 75mg/m2 followed by Rhenium-188 HEDP , followed by another 3 cycles of docetaxel, followed by Rhenium-188 HEDP. Cabazitaxel is a promising new drug to be used for the treatment of metastatic castrate resistant prostate cancer (mCRPC) after progression on docetaxel therapy.
In this study, we build upon previous results and we aim to test whether the combination of cabazitaxel with repeated Rhenium-188 HEDP is feasible and leads to better PFS, OS and pain control compared to cabazitaxel alone in patients with mCRPC after progression of disease after first line docetaxel. We start with a phase I dose finding trial, immediately followed by a phase II trial if the envisaged schedule is feasible.
Study objective
In this study, we build upon previous results and we aim to test whether the combination of cabazitaxel with repeated Rhenium-188 HEDP is feasible and leads to better PFS, OS and pain control compared to cabazitaxel alone in patients with mCRPC after progression of disease after first line docetaxel. We start with a phase I dose finding trial, immediately followed by a phase II trial if the envisaged schedule is feasible.
Study design
The study will take about 2 years starting approximately at 01-02-2012.
Intervention
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 randomized phase II part of the study. Patients will be randomised between treatment with Cabazitaxel monotherapie or combination therapy with Cabazitaxel and Rhenium-188 HEDP.
Utrechtseweg 160
H.J. Bloemendal
Amersfoort 3818 ES
The Netherlands
+31 (0)33 8502444
h.bloemendal@meandermc.nl
Utrechtseweg 160
H.J. Bloemendal
Amersfoort 3818 ES
The Netherlands
+31 (0)33 8502444
h.bloemendal@meandermc.nl
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 < 10 x ULN;
10. Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial;
11. Written informed consent;
12. Bone metastases must show uptake of Tc-99m-HDP on bone scintigraphy;
13. Adequate hematological function defined as: Haemoglobin > 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
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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL3085 |
| NTR-old | NTR3233 |
| Other | VCMO : R-11-46M |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |
Summary results
A phase I study of combined docetaxel and repeated high activity 186Re-HEDP in castration-resistant prostate cancer (CRPC) metastatic to bone (the TAXIUM trial).<br>
van Dodewaard-de Jong JM, de Klerk JM, Bloemendal HJ, van Bezooijen BP, de Haas MJ, Wilson RH, O'Sullivan JM.