Mitoxantrone, Prednisone Plus Sorafenib in Taxane-Refractory Metastatic Hormone Refractory Prostate Cancer (HRPC)
The primary objective of this study is to test the hypothesis that the combination of
Mitoxantrone, Prednisone and Sorafenib in taxane-refractory patients with metastatic hormone
refractory prostate cancer (mHRPC) will result in an improvement of the median time to
progression (TTP). Since the median (i.e 50% of patients) TTP for Mitoxantrone/Prednisone is
3 months, our hypothesis is that 70% will have not progressed at 3 months with this
investigational combination. Progression will be assessed by radiologic imaging criteria.
The early stopping point is 21 subjects. If 10 or fewer subjects with tumor favorable
response are observed when 21 subjects are accrued then the null hypothesis is accepted and
the trial is terminated. If 16 or more subjects with tumor favorable response are observed
when 21 subjects are accrued then the alternative hypothesis is accepted and the trial is
terminated. The probability of early stopping under the null is 0.51, and under the
alternative is 0.39. If the trial progresses until 42 subjects are evaluated and 24 or more
subjects with favorable response are observed then the null hypothesis is rejected. This
design minimizes the average sample number under the null, which is 31.2.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Median Time to Progression (TTP) by Imaging
Time to progression is defined as the time from treatment start until objective tumor progression. The median time to progression is the parameter used to describe TTP.
Radiologic imaging was repeated after every 4 cycles (approximately every 12 weeks) during study treatment.
Vasily Assikis, MD
Peachtree Hematology Oncology Consultants
United States: Institutional Review Board
|Wilshire Oncology Medical Group, Inc.||Rancho Cucamonga, California 91730|
|Mid-Ohio Oncology/Hematology, Inc.||Columbus, Ohio 43222|
|Lancaster Cancer Center||Lancaster, Pennsylvania 17604|
|The West Clinic||Memphis, Tennessee 38120|
|Northwest Georgia Oncology Centers||Marietta, Georgia 30060|
|Hematology Oncology Centers of the Northern Rockies, PC||Billings, Montana 59101|
|Cancer Specialists of Tidewater||Chesapeake, Virginia|
|Central Georgia Cancer Care||Macon, Georgia 31201|
|Peachtree Hematology Oncology Consultants||Atlanta, Georgia 30309|
|Pennsylvania Oncology Hematmology Associates||Philadelphia, Pennsylvania 19106|