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

A phase II study in mCRPC on the pharmacodynamic effects of budesonide on cabazitaxel (Jevtana®): A randomised, open-label multicenter study: CABARESC.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON27669

Enrollment

250

Registered

2011-07-20

Start date

2011-09-15

Completion date

Unknown

Last updated

2024-06-11

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

Conditions

cabazitaxel

Interventions

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

Eligibility

Inclusion criteria

Inclusion criteria: 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 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 criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
The effects of budesonide on the incidence of cabazitaxel induced diarrhea.	—

Secondary

Measure	Time frame
1. The effects of budesonide on other side effects of cabazitaxel (e.g. myelotoxicity); 2. Pharmacogenetics of cabazitaxel.	—

Contacts

Public ContactRon H.J. Mathijssen

Erasmus MC Rotterdam – Daniel den Hoed Cancer Center Department of Medical Oncology Room G4-80

a.mathijssen@erasmusmc.nl+31 (0)10 7041338, buzzer 229

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)