Metastatic Prostate Cancer Clinical Trial
Official title:
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
This study is designed to evaluate the safety of biweekly cabazitaxel for the treatment of metastatic castration resistant prostate cancer (mCRPC) patients previously treated with docetaxel containing regimen. The primary endpoint is safety. Secondary endpoints include time to treatment failure, response rate, overall survival and quality of life.
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.
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Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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