A Phase II Study of Cabazitaxel in Patients With Urothelial Carcinoma Who Have Disease Progression Following Platinum-Based Chemotherapy
This is a single-arm, open-label study, meaning all patients will be treated in the same
fashion with the investigational agent. Scans will be performed every 3 cycles of treatment,
and patients will be withdrawn from study in the event of progression or drug intolerance as
defined within the protocol.
Treatment will be administered on an outpatient basis. No investigational or commercial
agents or therapies other than those described below may be administered with the intent to
treat the patient's malignancy.
The length of each cycle is 21 days. For the first cycle of treatment, cabazitaxel will be
dosed at 20 mg/m2. During cycle 1, complete blood counts will be performed on days 8 and 15,
and dosing on Day 1 cycle 2 will depend upon the nadir counts on those days. If, on toxicity
assessment on day 1 of cycle 2, the patient has no residual >grade 2 toxicity, and all other
laboratory parameters are within acceptable limits (see below),at the investigator's
discretion the dose can be escalated to 25 mg/m2. 25 mg/m2 is the FDA (Food and Drug
Administration)-approved dose for prostate cancer. Neulasta will be given with each dose of
cabazitaxel to decrease the risk of febrile neutropenic complication.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall Response Rate
To determine the overall response rate of patients who have disease response while on treatment with Cabazitaxel. CT scan will be used to measure tumor pre-treatment and then every 3 cycles (every 63 days)
Pre-treatment and then every 3 cycles or 63 days
Yes
Jean Hoffman-Censits, MD
Principal Investigator
Thomas Jefferson University
United States: Food and Drug Administration
11D.392
NCT01437488
February 2012
September 2017
Name | Location |
---|---|
University of Pennsylvania | Philadelphia, Pennsylvania 19104 |
Thomas Jefferson University | Philadelphia, Pennsylvania 19107-6541 |
National Cancer Institute | Bethesda, Maryland 20892-1922 |