Study of Irofulven in Patients With Hormone-refractory Prostate Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

135

Participants

Timeline

Start Date

June 30, 2004

Primary Completion Date

January 31, 2006

Study Completion Date

December 31, 2009

Conditions
Prostate Cancer
Interventions
DRUG

Irofulven

Subjects will receive irofulven in a 30 minute intravenous (IV) infusion at a dose of 0.45 mg/kg on Days 1 and 8 every 3 weeks.

DRUG

Prednisone

Subjects will also receive oral prednisone at a dose of 10 mg per day in the morning.

DRUG

Mitoxantrone

Subjects will receive mitoxantrone in an intravenous (IV) infusion (5 to 15 minutes) at a dose of 12 mg/m\^2 per day, once every 3 weeks.

DRUG

Capecitabine

Subjects will receive oral capecitabine at a dose of 1000 mg/m\^2 twice daily for 15 days every 28 days.

DRUG

Irofulven

Subjects will receive irofulven in a 30 minute intravenous (IV) infusion at a dose of 0.4 mg/kg on Days 1 and 15 every 4 weeks.

Trial Locations (50)

Unknown

Hot Springs

Jonesboro

Greenbrae

Colorado Springs

Bonita Springs

Bradenton

Cape Coral

Fort Meyers

Naples

Port Charlotte

Sarasota

Venice

Atlanta

Augusta

Macon

Marietta

Chicago

Minneapolis

Billings

Albany

East Setauket

Kettering

Greenville

Nashville

Dallas

Fort Worth

Tyler

Spokane

Marshfield

Belo Horizonte

Porto Alegre

Rio de Janeiro

Calgary

Vancouver

Winnipeg

London

Montreal

Santiago

Zagreb

Avignon

Orléans

Paris

Saint-Brieuc

Saint-Grégoire

Lima

Bucharest

Cluj-Napoca

Arkhangelsk

Chelyabinsk

Moscow

All Listed Sponsors
lead

Eisai Inc.

INDUSTRY

NCT00124566 - Study of Irofulven in Patients With Hormone-refractory Prostate Cancer | Biotech Hunter | Biotech Hunter