The 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…
ID
Bron
Verkorte titel
Aandoening
cabazitaxel; budesonide; diarrhea; prostate cancer
cabazitaxel; budesonide; diarree; prostaatkanker
Ondersteuning
Erasmus MC Rotterdam – Daniel den Hoed Cancer Center
Groene Hilledijk 301
3075 EA Rotterdam
The Netherlands
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The effects of budesonide on the incidence of cabazitaxel induced diarrhea.
Achtergrond van het onderzoek
Cabazitaxel 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.
Doel van het onderzoek
The 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%.
Onderzoeksopzet
3 weekly during 10 cycles of cabazitaxel of 3 weeks.
Onderzoeksproduct en/of interventie
All 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.
Publiek
Ron H.J. Mathijssen
Groene Hilledijk 301
Rotterdam 3075 EA
The Netherlands
+31 (0)10 7041338, buzzer 229
a.mathijssen@erasmusmc.nl
Wetenschappelijk
Ron H.J. Mathijssen
Groene Hilledijk 301
Rotterdam 3075 EA
The Netherlands
+31 (0)10 7041338, buzzer 229
a.mathijssen@erasmusmc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. 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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. 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.
Opzet
Deelname
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL2849 |
| NTR-old | NTR2991 |
| CCMO | NL37676.078.11 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |
| OMON | NL-OMON41486 |