UCSF Helen Diller Family Comprehensive Cancer Center
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Protocol No.11951Principal InvestigatorAggarwal, Rahul
PhaseI (Cancer Control)
Age GroupAdultScopeNational
Secondary Protocol No.N/A
TitleA Phase I Study of Cabazitaxel, Mitoxantrone, and Prednisone (CAMP) for Patients with Metastatic Castration-Resistant Prostate Cancer and no Prior Chemotherapy
ObjectivePrimary Objective: To determine the MTD and dose-limiting toxicities of the combination of cabazitaxel and mitoxantrone/prednisone as chemotherapy for patients with metastatic CRPC who have not received prior chemotherapy for metastatic disease.
Key Eligibility1. Histologically confirmed adenocarcinoma of the prostate. 2. Progressive metastatic prostate cancer (positive bone scan or measurable disease) despite castrate levels of testosterone (either from orchiectomy or LHRH agonist therapy). 3. Patients may have either non-measurable disease OR measurable disease 4. All patients must have a PSA >/= 2 ng/mL. 5. Progressive disease based on any one of the following: transaxial imaging; a rise in PSA; radionuclide bone scan *Patients whose sole manifestation of progression is an increase in disease-related symptoms are not eligible.
Applicable Disease SitesProstate
Therapies InvolvedChemotherapy multiple agents systemic
Drugs InvolvedCabazitaxel
Immunex (Mitoxantrone)
Jevtana (Cabazitaxel)
Mitoxantrone dihydrochloride (Mitoxantrone)
Mitoxantrone hydrochloride (Mitoxantrone)
Novantron (Mitoxantrone)
XRP6258 (Cabazitaxel)
Participating InstitutionsCTSI CRC Mt. Zion
Mayo Clinic-Arizona
University of California San Francisco
Vanderbilt University
Vanderbilt-Ingram Cancer Center
Eligibility Document11951_CTGovEligibility_NCT01594918.doc