NCT01541007

A Study Looking at Novel Scheduling of Cabazitaxel for Patients With Metastatic Prostate Cancer

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Jeffrey Yachnin M.D., PhD. · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Metastatic Castration Resistant Prostate Cancer

Interventions

Type	Name	Description
DRUG	Cabazitaxel	25 mg/m2 every three weeks
DRUG	weekly cabazitaxel	10 mg/m2 dag 1,8,15,22. Cycle length is 6 weeks

Timeline

• Start date: 2012-04-01
• Primary completion: 2015-10-01
• Completion: 2015-10-01
• First posted: 2012-02-29
• Last updated: 2015-11-02

Locations

1 site across 1 country: Sweden