Primary objective: To study the effects of budesonide on the incidence of cabazitaxel induced diarrhea Secondary objectives: To study the effects of budesonide on other side effects of cabazitaxel (e.g. myelotoxicity), To study the pharmacogenetics…
ID
Source
Brief title
Condition
- Reproductive neoplasms male malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Incidence of cabazitaxel-induced diarrhea.
Secondary outcome
Incidence of other side effects of cabazitaxel. Pharmacogenetics of
cabazitaxel.
Background summary
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.
Study objective
Primary objective: To study the effects of budesonide on the incidence of
cabazitaxel induced diarrhea
Secondary objectives: To study the effects of budesonide on other side effects
of cabazitaxel (e.g. myelotoxicity), To study the pharmacogenetics of
cabazitaxel.
Study design
Multicenter randomized open phase II parallel group study.
Patient will be randomly allocated to either:
• Budesonide 9 mg daily starting 2 days prior to cycle 1 until 2 weeks, for a
maximum of 44 consecutive days.
• No budesonide.
All patiënts will be treated with cabazitaxel 25 mg/m2 via i.v. infusion of
approx. 1 h, once every 3 weeks. Max. 10 cycles. No dose capping. Premature
discontinuation in case of disease progression or unacceptable toxocity.
250 patients to be included.
Interim-analysis (safety) after 50 % inclusion.
Substudies:
- counting and characterization of circulating tumor cells.
- development of a biomarker prophyle for future prediction of positive
response to cabazitaxel.
Intervention
Treatment with or without budesonide.
Study burden and risks
Risk: adverse events of study medication.
Burden:
Visits, investigations similar to standard treatment with cabazitaxel.
Diary (diarrhea) from 7 days prior to 1st cycle until start 3rd cycle.
Optional blood draw for pharmacogenetic research (20 ml) and research for
circulating tumor cells (20 ml). Rest: storage for future research.
Substudy circulating tumor cells(optional): 20 ml. blood on 2 occasions.
Substudy biomarker prophyle (optional): 2x tumor biopsy.
Groene Hilledijk 301
Rotterdam 3075 EA
NL
Groene Hilledijk 301
Rotterdam 3075 EA
NL
Listed location countries
Age
Inclusion criteria
• Metastatic castrate resistant prostate cancer patients with documented disease progression (Resist criteria (measurable disease) or PSA (non-measurable disease))
• Previous treatment with a docetaxel-containing regimen
• Age 18 years and above
• WHO performance status 0-1
• Castration, either surgically or by continued LHRH agonist therapy.
Exclusion criteria
• CYP3A inducers or inhibitors
• Systemic or local bacterial, viral, fungal or yeast infection
• Portal hypertension (grade 1-4 CTC-NCI criteria)
• Ulcerative colitis, Crohn*s disease or celiac disease
• Simultaneous yellow fever vaccine.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2011-003346-40-NL |
| CCMO | NL37676.078.11 |
| Other | www.trialregister.nl, registratienummer NTR2991 |