Cabazitaxel in Patients With Urothelial Carcinoma Who Have Disease Progression Following Platinum-Based Chemotherapy

PHASE2CompletedINTERVENTIONAL
Enrollment

14

Participants

Timeline

Start Date

February 16, 2012

Primary Completion Date

August 4, 2014

Study Completion Date

March 30, 2017

Conditions
Urothelial Carcinoma
Interventions
DRUG

Cabazitaxel

"* Cycle 1: 20 mg/m2 in 250cc NS via IV on Day 1 every 21 days~* Following cycles: 20 mg/m2 or escalated to 25 mg/m2 or reduced by 5 mg/m2 in 250cc NS via IV on Day 1 every 21 days at investigator's discretion~* Treatment continues until disease progression, intercurrent illness preventing further treatment, unacceptable adverse event(s), patient withdraws from the study, or changes in the patient's condition which render further treatment unacceptable in the judgment of the investigator"

DRUG

Neulasta

6 mg via SQ on Day 2 (24-48 hours post-cabazitaxel) every 21 days

PROCEDURE

CT Scan

CT scan of chest, abdomen, and pelvis to assess disease following every 3rd cycle of treatment (approximately every 9 weeks)

BIOLOGICAL

Blood Draw

Approximately 2 tablespoons of blood will be taken to test complete blood count, glucose, hematology, electrolytes, liver function, creatinine clearance, and a chemistry profile. This week be done weekly during the first cycle of treatment

Trial Locations (3)

19104

University of Pennsylvania, Philadelphia

19107

Thomas Jefferson University, Philadelphia

20892

National Cancer Institute, Bethesda

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Sanofi

INDUSTRY

lead

Sidney Kimmel Cancer Center at Thomas Jefferson University

OTHER

NCT01437488 - Cabazitaxel in Patients With Urothelial Carcinoma Who Have Disease Progression Following Platinum-Based Chemotherapy | Biotech Hunter | Biotech Hunter