Neoadjuvant ABI-007, Carboplatin and Gemcitabine in Locally Advanced Bladder Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

29

Participants

Timeline

Start Date

December 31, 2007

Primary Completion Date

April 30, 2013

Study Completion Date

April 30, 2013

Conditions
Bladder Cancer
Interventions
DRUG

ABI-007

ABI-007 will be administered at a dose of 260 mg/m2 over a 30 min IV infusion on day 1 of each 21 day cycle.

DRUG

Carboplatin

Carboplatin will be administered at a dose of TARGET AUC=5 over a 15 min IV infusion of day 1 of each 21 day cycle.

DRUG

Gemcitabine

Gemcitabine will be administered at a dose of 800 mg/m2 over a 30 min IV infusion on days 1 and 8 of each 21 day cycle.

PROCEDURE

Radical Cystectomy

Trial Locations (1)

48109

University of Michigan, Ann Arbor

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Celgene Corporation

INDUSTRY

lead

University of Michigan Rogel Cancer Center

OTHER