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A Randomized, Open Label, Multicenter, Phase II Trial Comparing The Conventional 3 Weekly Schedule Of Cabazitaxel With A Weekly Regimen In Patients With Metastatic Castration Resistant Prostate Cancer
Cabazitaxel has shown significant efficacy as second line chemotherapy after Docetaxel in men with metastatic castration resistant prostate cancer. This was demonstrated in the Tropic Study where Cabazitaxel showed survival superiority compared to mitoxantrone. Almost one in 4 patients treated with Cabazitaxel in this study required dose reductions or dose delays or stopped treatment due to toxicity. ConCab examines another scheduling for cabazitaxel to see if we can improve tolerability so that patients will receive a higher percentage of the treatment as planned.
ConCab compares the standard treatment of cabazitaxel 25 mg/m2 every three weeks with an experimental scheduling of 10 mg/m2 for 5 consecutive weeks of a 6 week cycle. In both study arms the planned cumulative dose of cabazitaxel at week 18 is 150 mg/m2. Our study aims to evaluate differences in the total received dose in relation to the planned dose as a measure of which of the 2 treatment schedules is superior.
Age
18 - No limit years
Sex
MALE
Healthy Volunteers
No
Deapartment of Oncology Karolinska University Hospital
Stockholm, Sweden
Start Date
April 1, 2012
Primary Completion Date
October 1, 2015
Completion Date
October 1, 2015
Last Updated
November 2, 2015
100
ACTUAL participants
Cabazitaxel
DRUG
weekly cabazitaxel
DRUG
Lead Sponsor
Jeffrey Yachnin M.D., PhD.
Collaborators
NCT07285694
NCT06830850
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT06517719