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Sponsors and Collaborators: |
Accelerated Community Oncology Research Network Bayer |
Information provided by: | Accelerated Community Oncology Research Network |
ClinicalTrials.gov Identifier: | NCT00452387 |
The purpose of this research study is to determine if the combination of mitoxantrone, prednisone and sorafenib will improve the time to progression of advanced stage metastatic hormone-refractory prostate cancer.
Condition | Intervention | Phase |
Metastatic Prostate Cancer |
Drug: Mitoxantrone Drug: Prednisone Drug: Sorafenib |
Phase II |
MedlinePlus related topics: | Cancer Prostate Cancer |
ChemIDplus related topics: | Mitoxantrone hydrochloride Mitoxantrone Prednisone Sorafenib Sorafenib tosylate |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Mitoxantrone, Prednisone Plus Sorafenib in Taxane-Refractory Metastatic Hormone Refractory Prostate Cancer (HRPC) |
Estimated Enrollment: | 42 |
Study Start Date: | May 2007 |
Study Completion Date: | July 2008 |
Estimated Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Experimental
Once six patients are accrued at dose level 1, MTD will be assessed by following them through one cycle of treatment. If 2/6 patients experience dose limiting toxicity (DLT) at the 400 mg bid level then the MTD will be defined as 400 mg QD. Additional patients will be enrolled at the MTD for the phase II portion. Dose Level -2, Mitoxantrone 9mg/m2 + Prednisone 5mg bid Sorafenib 400 mg QD Dose Level -1 Mitoxantrone 12mg/m2 + Prednisone 5mg bid Sorafenib 400 mg QD Dose Level 1 Mitoxantrone 12mg/m2 + Prednisone 5mg bid Sorafenib 400 mg bid |
Drug: Mitoxantrone
Once six patients are accrued at dose level 1, MTD will be assessed by following them through one cycle of treatment. If 2/6 patients experience dose limiting toxicity (DLT) at the 400 mg bid level then the MTD will be defined as 400 mg QD. Additional patients will be enrolled at the MTD for the phase II portion. Dose Level -2, Mitoxantrone 9mg/m2 Dose Level -1 Mitoxantrone 12mg/m2 Dose Level 1 Mitoxantrone 12mg/m2 Once six patients are accrued at dose level 1, MTD will be assessed by following them through one cycle of treatment. If 2/6 patients experience dose limiting toxicity (DLT) at the 400 mg bid level then the MTD will be defined as 400 mg QD. Additional patients will be enrolled at the MTD for the phase II portion. Dose Level -2, Prednisone 5mg bid Dose Level -1 Prednisone 5mg bid Dose Level 1 Prednisone 5mg bid Once six patients are accrued at dose level 1, MTD will be assessed by following them through one cycle of treatment. If 2/6 patients experience dose limiting toxicity (DLT) at the 400 mg bid level then the MTD will be defined as 400 mg QD. Additional patients will be enrolled at the MTD for the phase II portion. Dose Level -2, Sorafenib 400 mg QD Dose Level -1 Sorafenib 400 mg QD Dose Level 1 Sorafenib 400 mg bid |
The primary objective of this study is to test the hypothesis that the combination of Mitoxantrone, Prednisone and Sorafenib in taxane-refractory patients with 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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Adequate bone marrow, liver and renal function as assessed by the following:
Exclusion Criteria:
United States, California | |||||
Wilshire Oncology Medical Group, Inc. | |||||
La Verne, California, United States, 91750 | |||||
United States, Georgia | |||||
Central Georgia Cancer Care | |||||
Macon, Georgia, United States, 31201 | |||||
Northwest Georgia Oncology Centers | |||||
Marietta, Georgia, United States, 30060 | |||||
Peachtree Hematology Oncology Consultants | |||||
Atlanta, Georgia, United States, 30309 | |||||
United States, Montana | |||||
Hematology Oncology Centers of the Northern Rockies, PC | |||||
Billings, Montana, United States, 59101 | |||||
United States, Ohio | |||||
Mid-Ohio Oncology/Hematology, Inc. | |||||
Columbus, Ohio, United States, 43213 | |||||
United States, Pennsylvania | |||||
Lancaster Cancer Center | |||||
Lancaster, Pennsylvania, United States, 17605 | |||||
Pennsylvania Oncology Hematmology Associates | |||||
Philadelphia, Pennsylvania, United States, 19106 | |||||
United States, Tennessee | |||||
The West Clinic | |||||
Memphis, Tennessee, United States, 38120 | |||||
United States, Virginia | |||||
Cancer Specialists of Tidewater | |||||
Chesapeake, Virginia, United States, 23320 |
Accelerated Community Oncology Research Network |
Bayer |
Principal Investigator: | Vasily Assikis, MD | Peachtree Hematology Oncology Consultants |
Responsible Party: | Accelerated Community Oncology Research Network ( Amanda Johns, RHIA, CCRP ) |
Study ID Numbers: | ACORN AVAHRPC0607 |
First Received: | March 26, 2007 |
Last Updated: | July 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00452387 |
Health Authority: | United States: Institutional Review Board |
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