Second-line Chemotherapy in Castration Resistant Prostate Cancer (ProstyII)
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.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Safety and tolerabilty [ Time Frame: every 2 weeks ] [ Designated as safety issue: Yes ]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
- Response rate [ Time Frame: PSA every 6 week, tumor assesment every 12 week ] [ Designated as safety issue: No ]Recist version 1.1 (response evaluation of solid solid tumors; Eisenhauer et al. JCO 2009;45:228-247)
|Study Start Date:||November 2011|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Experimental: acitive anticancer drug
single cytostatic agent, cabazitaxel every second week in the treatment of castration resistant metastatic prostate cancer after docetaxel
Jevtana® (cabazitaxel) 16 mg/m2 IV in 1 hour on day 1 given every second week
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.
|Contact: Pirkko-Liisa I Kellokumpu-Lehtinen, MD,Phdfirstname.lastname@example.org|
|Tampere University Hospital||Recruiting|
|Tampere, Finland, 33520|
|Principal Investigator: Pirkko-Liisa I Kellokumpu-Lehtinen, MD, PhD|
|Principal Investigator:||Pirkko-Liisa I kellokumpu-Lehtinen, MD, PhD||Tampere University Hospital|