Open, Single-arm, Multicenter, Phase II Trial Investigating the Safety of Biweekly Cabazitaxel in Metastatic Castration Resistant Prostate Cancer Patients Previously Treated With a Docetaxel-containing Regimen
The objective of this study is to explore new, biweekly schedule of cabazitaxel in
metastatic castration resistant prostate cancer patients. A previous study has shown that
the biweekly administration of docetaxel in 1st line setting of mCRPC is better tolerated
than docetaxel administered every three weeks. Also, the efficacy of biweekly docetaxel was
better than three-weekly docetaxel and biweekly dosing presented a significant overall
survival benefit (ASCO 2011, Kellokumpu-Lehtinen et al. As the occurrence of neutropenia in
the TROPIC trial was rather high, the hypothesis is to reduce the incidence of severe
adverse events by administrating cabazitaxel more frequently, yet maintaining the same dose
intensity as in every three weeks´ dosing schedule.
This study is designed to evaluate the safety of biweekly cabazitaxel for the treatment of
60 patients with metastatic castration resistant prostate cancer (mCRPC) patients previously
treated with docetaxel containing regimen.
Interventional
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Safety and tolerabilty
NCI CTC-AE version 4 Adverse events in every organ systems and laborotory values (Grades from 0 to 5, 0=no adverse events, 5= dead)from baseline up to the end of the treatment
every 2 weeks
Yes
Pirkko-Liisa I kellokumpu-Lehtinen, MD, PhD
Principal Investigator
Tampere University Hospital
Finland: Finnish Medicines Agency
2011-003156-39
NCT01558219
November 2011
December 2014
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