Cabazitaxel in Patients With Urothelial Carcinoma Who Have Disease Progression Following Platinum-Based Chemotherapy
There is no accepted standard chemotherapy approved for use in the second line for patients with advanced urothelial carcinoma whose cancer has progressed on combination chemotherapy including either cisplatin or carboplatin. The chemotherapy class called taxanes, either as single agents or in combination, have demonstrated modest efficacy in small studies. Cabazitaxel is an agent in the taxane family designed to be active in the setting of acquired multi-drug resistance that arises in some tumors. The objective of this study is to evaluate the safety and efficacy of this agent in patients with urothelial carcinoma refractory compared to combination platinum based chemotherapy.
Procedure: CT Scan
Biological: Blood Draw
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Cabazitaxel in Patients With Urothelial Carcinoma Who Have Disease Progression Following Platinum-Based Chemotherapy|
- Overall Response Rate [ Time Frame: Pre-treatment and then every 3 cycles or 63 days ] [ Designated as safety issue: Yes ]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)
- Overall Survival [ Time Frame: At 12 months ] [ Designated as safety issue: No ]To determine the percentage of patients alive at 12 months from trial entry. Overall survival will be measured from date of randomization to date of death due to any cause.
- Progression Free Survival [ Time Frame: Every 3 cycles or 63 days ] [ Designated as safety issue: No ]To determine the progression free survival (PFS) of patients with advanced or recurrent urothelial carcinoma who have previously been treated with a platinum based regimen while on treatment with cabazitaxel. Defined as a 20% increase in the largest diameter of the largest lesion by CT scan.
- Safety and Tolerability of Cabazitaxel [ Time Frame: Every 1 cycle or 21 days ] [ Designated as safety issue: Yes ]Determined through dose modifications according to patient's toxicity levels. For example, if after Cycle 1 the patient shows no residual toxicity, the dose level will be increased.
|Study Start Date:||February 2012|
|Estimated Study Completion Date:||September 2017|
|Estimated Primary Completion Date:||September 2015 (Final data collection date for primary outcome measure)|
Cabazitaxel following platinum-based chemotherapy
Other Names:Drug: Neulasta
6 mg via SQ on Day 2 (24-48 hours post-cabazitaxel) every 21 days
Other Name: PegfilgrastimProcedure: CT Scan
CT scan of chest, abdomen, and pelvis to assess disease following every 3rd cycle of treatment (approximately every 9 weeks)
Other Names: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
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.
|Contact: Jean Hoffman-Censits, MD||215-955-8874|
|Contact: Clinical Research Management Office||215-955-1661|
|United States, Maryland|
|National Cancer Institute||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: Andrea Apolo, MD|
|Contact: Laura Otten, RN, BSN, OCN 301-451-1228|
|Principal Investigator: Andrea Apolo, MD|
|Sub-Investigator: William Douglas Figg, PharmD|
|United States, Pennsylvania|
|Thomas Jefferson University||Recruiting|
|Philadelphia, Pennsylvania, United States, 19107|
|Contact: Jean Hoffman-Censits, MD 215-955-8874|
|Contact: Clinical Research Management Office 215-955-1661|
|Principal Investigator: Jean Hoffman-Censits, MD|
|Sub-Investigator: Wm. Kevin Kelly, DO|
|Sub-Investigator: Jianqing Lin, MD|
|Sub-Investigator: Andrew Chapman, DO|
|Sub-Investigator: Edouard Trabulsi, MD|
|Sub-Investigator: Leonard Gomella, MD|
|University of Pennsylvania||Recruiting|
|Philadelphia, Pennsylvania, United States, 19104|
|Contact: David Vaughn, MD 215-349-8140|
|Principal Investigator: David Vaughn, MD|
|Principal Investigator:||Jean Hoffman-Censits, MD||Thomas Jefferson University|