First-line Everolimus +/- Paclitaxel for Cisplatin-ineligible Patients With Advanced Urothelial Carcinoma

PHASE2TerminatedINTERVENTIONAL
Enrollment

36

Participants

Timeline

Start Date

December 31, 2010

Primary Completion Date

April 24, 2017

Study Completion Date

April 24, 2018

Conditions
Transitional Cell CarcinomaBladder CarcinomaUrothelial Carcinoma
Interventions
DRUG

Everolimus

10 mg PO daily (continuously, without scheduled treatment interruptions). The cycle length will last 28 days. Everolimus will be dispensed on Day 1 of each cycle by the study center personnel on an outpatient basis.

DRUG

Everolimus

10 mg PO daily (continuously, without scheduled treatment interruptions). The cycle length will last 28 days. Everolimus will be dispensed on Day 1 of each cycle by the study center personnel on an outpatient basis.

DRUG

Paclitaxel

Paclitaxel 80 mg/m2 IV as a 1 hour infusion on days 1, 8, and 15, of a 28-day cycle.

Trial Locations (11)

10029

Icahn School of Medicine: Tisch Cancer Institute at Mount Sinai Medical Center, New York

23502

Virginia Oncology Associates, Norfolk

29425

MUSC Hollings Cancer Center, Charleston

35294

University of Alabama Hematology Oncology Clinic at Medical West, Birmingham

46202

Indiana University Melvin and Bren Simon Cancer Center, Indianapolis

46219

IU Health Central Indiana Cancer Centers, Indianapolis

47403

Cancer Care Center of Southern Indiana, Bloomington

49519

Metro Health Cancer Care, Wyoming

60611

Northwestern University, Robert H. Lurie Comprehensive Cancer Center, Chicago

68114

Nebraska Cancer Specialists, Omaha

77555

University of Texas Medical Branch, Galveston

All Listed Sponsors
collaborator

Hoosier Cancer Research Network

OTHER

collaborator

Novartis Pharmaceuticals

INDUSTRY

lead

Matthew Galsky

OTHER