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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.


- candidate number10793
- NTR NumberNTR3233
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR28-dec-2011
- Secondary IDsR-11-46M VCMO
- Public TitleA 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.
- Scientific TitleA 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.
- ACRONYMReCab study
- hypothesisIn 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.
- Healt Condition(s) or Problem(s) studiedPatients with castration resistant metastatic prostate cancer to the bone
- Inclusion criteria1. 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 criteria1. 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.
- mec approval receivedno
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-feb-2012
- planned closingdate1-feb-2014
- Target number of participants90
- InterventionsIn 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.
- Primary outcomeProgression 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 outcomeQoL score every (EORTC QlQ 30), pain score (VAS score), skeletal related events, Toxicity (NCI-CTC version 3) every three weeks.
- TimepointsThe study will take about 2 years starting approximately at 01-02-2012.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESMD. PhD. H.J. Bloemendal
- CONTACT for SCIENTIFIC QUERIESMD. PhD. H.J. Bloemendal
- Sponsor/Initiator Meander Medical Center Amersfoort
- Funding
(Source(s) of Monetary or Material Support)
Meander Medical Center Amersfoort
- PublicationsEur J Nucl Med Mol Imaging. 2011 Nov;38(11):1990-8. Epub 2011 Jul 27. 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).
van Dodewaard-de Jong JM, de Klerk JM, Bloemendal HJ, van Bezooijen BP, de Haas MJ, Wilson RH, O'Sullivan JM.
- Brief summaryProstate 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.
- Main changes (audit trail)
- RECORD28-dec-2011 - 29-jan-2012


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