22
Participants
Start Date
May 31, 2007
Primary Completion Date
July 31, 2008
Study Completion Date
January 31, 2009
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"
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"
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"
Lancaster Cancer Center, Lancaster
Pennsylvania Oncology Hematmology Associates, Philadelphia
Cancer Specialists of Tidewater, Chesapeake
Northwest Georgia Oncology Centers, Marietta
Peachtree Hematology Oncology Consultants, Atlanta
Central Georgia Cancer Care, Macon
The West Clinic, Memphis
Mid-Ohio Oncology/Hematology, Inc., Columbus
Hematology Oncology Centers of the Northern Rockies, PC, Billings
Wilshire Oncology Medical Group, Inc., La Verne
Collaborators (1)
Bayer
INDUSTRY
Accelerated Community Oncology Research Network
OTHER