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van CCT (UK)

van CCT (UK)

Effects of budesonide on the toxicity of cabazitaxel in metastatic castrate-resistant prostate cancer.

- candidate number10168
- NTR NumberNTR2991
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR20-jul-2011
- Secondary IDsNL37676.078.11 CCMO
- Public TitleEffects of budesonide on the toxicity of cabazitaxel in metastatic castrate-resistant prostate cancer.
- Scientific TitleA phase II study in mCRPC on the pharmacodynamic effects of budesonide on cabazitaxel (Jevtana®): A randomised, open-label multicenter study: CABARESC.
- hypothesisThe primary aim of this trial is to evaluate whether the addition of budesonide to cabazitaxel results in a lower proportion of patients with grade 2-4 diarrhea during the 1st and/or 2nd cycle. It is assumed that the incidence of grade 2-4 diarrhea in the control group will be 25%.
- Healt Condition(s) or Problem(s) studiedProstate cancer, Diarrhea, Cabazitaxel, Budesonide
- Inclusion criteria1. Metastatic castrate resistant prostate cancer (mCRPC) patients with documented disease progression;
2. If measureable disease: documented disease progression as defined in RECIST criteria v 1.1;
3. If non-measurable disease: 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 lesions;
4. Previous treatment with a docetaxel-containing regimen;
5. Age ≥ 18 years;
6. WHO performance status ≥ 1 (see appendix B);
7. Adequate renal and hepatic functions defined as (serum creatinin <150µmol/l (<1.7mg/dl), total bilirubin < 1.0 xULN; alanine aminotransferase (ALAT) and aspartate aminotransferase (ASAT) <1.5x ULN, in case of liver metastasis < 5 ULN; alkaline phosphatase (AF) < 5x ULN) In case of bone metastasis, AF < 10x ULN is accepted;
8. Adequate hematological blood counts defined as (absolute neutrophil count (ANC) > 1.5 x 109/L and platelets > 100 x 109/L);
9. Castration, either surgically or by continued LHRH agonist therapy;
10. Written informed consent according to ICH-GCP.
- Exclusion criteria1. Impossibility or unwillingness to take oral drugs;
2. Serious illness or medical unstable condition requiring treatment, symptomatic CNS-metastases or history of psychiatric disorder that would prohibit the understanding and giving of informed consent;
3. Use of medications or dietary supplements known to induce or inhibit CYP3A (see section 5.11);
4. Use of hormonal agents other than Gn-RH agonists;
5. Chemotherapy within the last 4 weeks before randomization;
6. Radiotherapy within the last 4 weeks before randomization;
7. Known hypersensitiveness to corticosteroids;
8. Systemic or local bacterial, viral, fungal - or yeast infection;
9. Hepatic impairment (Child-Pugh score B-C);
10. Portal hypertension (grade 1-4 CTC-NCI criteria);
11. Ulcerative colitis, Crohn’s disease or celiac disease;
12. Simultaneous yellow fever vaccine.
- mec approval receivedno
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 15-sep-2011
- planned closingdate1-sep-2014
- Target number of participants250
- InterventionsAll patients are treated with cabazitaxel chemotherapy. The intervention group will receive budesonide oral 9 mg a day from 2 days before the first chemotherapy cyclus untill 2 weeks after the second cycle. The control group will not receive budesonide.
- Primary outcomeThe effects of budesonide on the incidence of cabazitaxel induced diarrhea.
- Secondary outcome1. The effects of budesonide on other side effects of cabazitaxel (e.g. myelotoxicity);
2. Pharmacogenetics of cabazitaxel.
- Timepoints3 weekly during 10 cycles of cabazitaxel of 3 weeks.
- Trial web siteN/A
- statusstopped: trial finished
- Sponsor/Initiator Erasmus Medical Center, Department of Medical Oncology, Daniel den Hoed Cancer Center
- Funding
(Source(s) of Monetary or Material Support)
Erasmus Medical Center, Department of Medical Oncology
- PublicationsNieuweboer et al. Effects of budesonide on cabazitaxel pharmacokinetics and cabazitaxel-induced diarrhea: A randomized open-label multicenter phase II study. Clin Cancer Res. 2016 Oct 4 [Epub ahead of print]
- Brief summaryCabazitaxel is a new drug to be used for the treatment of metastatic castrate resistant prostate cancer after progression on docetaxel therapy. Unfortunately, a relatively high incidence of diarrhea (50%, mainly during the 1st two cycles, median onset after 7 days of therapy) is limiting its dose/use.
The aim of this study is to assess the prophylactic effect of budesonide on cabazitaxel induced diarrhea. The hypothesis is that the local anti-inflammatory effects of budesonide will have a favorable effect on the incidence of diarrhea in cabazitaxel treatment. In a previous pharmacokinetic safety study no clear interaction between cabazitaxel and budesonide was shown.
- Main changes (audit trail)
- RECORD20-jul-2011 - 12-okt-2016

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