Neoadjuvant Cisplatin, Gemcitabine, Sunitinib Malate + Radical Cystectomy for TCC

PHASE2TerminatedINTERVENTIONAL
Enrollment

9

Participants

Timeline

Start Date

March 31, 2009

Primary Completion Date

April 30, 2011

Study Completion Date

April 30, 2011

Conditions
Transitional Cell Carcinoma of the Bladder
Interventions
DRUG

Gemcitabine

Gemcitabine ( 1000 mg/m2) IV days 1 and 8

DRUG

Cisplatin

Cisplatin (70 mg/m2) IV day 1

DRUG

Sunitinib Malate

Sunitinib malate (37.5 mg) oral daily for days 1-14

PROCEDURE

Radical Cystectomy

Radical cystectomy performed no sooner than 2 weeks but within 6 weeks of the last dose of sunitinib malate.

Trial Locations (5)

32610

University of Florida, Gainesville

46202

Indiana University Simon Cancer Center, Indianapolis

46601

Northern Indiana Cancer Research Consortium, South Bend

77030

Baylor College of Medicine, Houston

EC1A 7BE

St. Bartholomew's Hospital (Barts), London

Sponsors
All Listed Sponsors
collaborator

Pfizer

INDUSTRY

collaborator

Hoosier Cancer Research Network

OTHER

lead

Noah Hahn, M.D.

OTHER