Mitoxantrone, Prednisone Plus Sorafenib in Taxane-Refractory Metastatic Hormone Refractory Prostate Cancer (HRPC)

PHASE2TerminatedINTERVENTIONAL
Enrollment

22

Participants

Timeline

Start Date

May 31, 2007

Primary Completion Date

July 31, 2008

Study Completion Date

January 31, 2009

Conditions
Metastatic Prostate Cancer
Interventions
DRUG

Mitoxantrone

"Once six patients are accrued at dose level 1, the maximum tolerated dose (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 twice a day (bid) level then the MTD will be defined as 400 mg daily (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"

DRUG

Prednisone

"Once six patients are accrued at dose level 1, the maximum tolerated dose (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 twice a day (bid) level then the MTD will be defined as 400 mg daily (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"

DRUG

Sorafenib

"Once six patients are accrued at dose level 1, the maximum tolerated dose (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 twice a day (bid) level then the MTD will be defined as 400 mg daily (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"

Trial Locations (10)

17605

Lancaster Cancer Center, Lancaster

19106

Pennsylvania Oncology Hematmology Associates, Philadelphia

23320

Cancer Specialists of Tidewater, Chesapeake

30060

Northwest Georgia Oncology Centers, Marietta

30309

Peachtree Hematology Oncology Consultants, Atlanta

31201

Central Georgia Cancer Care, Macon

38120

The West Clinic, Memphis

43213

Mid-Ohio Oncology/Hematology, Inc., Columbus

59101

Hematology Oncology Centers of the Northern Rockies, PC, Billings

91750

Wilshire Oncology Medical Group, Inc., La Verne

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Bayer

INDUSTRY

lead

Accelerated Community Oncology Research Network

OTHER