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A Phase II Study of Cabazitaxel in Patients With Urothelial Carcinoma Who Have Disease Progression Following Platinum-Based Chemotherapy

Phase 2
18 Years
Open (Enrolling)
Urothelial Carcinoma

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Trial Information

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and patients will be withdrawn from study in the event of progression or drug intolerance as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.

Inclusion Criteria:

- Patients must have histologically confirmed urothelial carcinoma

- Patients must have measurable disease

- Patients must have been previously treated with a platinum-based regimen, either in
the neoadjuvant, adjuvant or first line setting

- Patients can have had disease progression while on platinum chemotherapy, or
progression within 12 months of completion of therapy

- At least 4 weeks must have passed since the last dose of previous chemotherapy

- Age > 18 years

- ECOG performance status < 2 (Karnofsky > 60%)

- Life expectancy of greater than 6 months

- Patients must have adequate organ and marrow function as defined below:

- absolute neutrophil count > 1,500/mcL

- hemoglobin > 9.0 g/dl

- platelets > 100,000/mm3

- total bilirubin < normal institutional limits (ULN)

- AST(SGOT)/ALT(SGPT) < 1.5 X institutional upper limit of normal

- creatinine <1.5 x ULN OR creatinine clearance measured > 50 mL/min/1.73 m2for
patients with creatinine levels above institutional normal or calculated clearance <
60 by 24 hour urine

- Peripheral neuropathy: must be < grade 1

- Women of childbearing potential must have a negative pregnancy test, and patients
must use adequate contraception during study and for 3 months thereafter

- Ability to understand and the willingness to sign a written informed consent

Exclusion Criteria:

- Patients with any component of small cell carcinoma

- Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for
nitrosoureas or mitomycin C) prior to entering the study or those who have not
recovered from adverse events due to agents administered more than 4 weeks earlier

- Patients who are receiving any other investigational agents

- Patients with known brain metastases

- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to taxane chemotherapy

- Patients with a history of severe hypersensitivity reaction to Cabazitaxel or other
drugs formulated with polysorbate 80

- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
study requirements

- Pregnant and breastfeeding women

- HIV-positive patients on combination antiretroviral therapy

- Patients who have previously been treated with taxane regimens for bladder cancer or
other malignancies

- Patients who have had more than one platinum based chemotherapy regimen

- Patients whose cancer has progressed more than 12 months following abstinence from
platinum based chemotherapy can be included on study at the discretion of the
investigator, however should first be considered for platinum re-challenge

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall Response Rate

Outcome Description:

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)

Outcome Time Frame:

Pre-treatment and then every 3 cycles or 63 days

Safety Issue:


Principal Investigator

Jean Hoffman-Censits, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Thomas Jefferson University


United States: Food and Drug Administration

Study ID:




Start Date:

February 2012

Completion Date:

September 2017

Related Keywords:

  • Urothelial Carcinoma
  • Urothelial carcinoma
  • Urothelial cancer
  • Carcinoma
  • Carcinoma, Transitional Cell
  • Disease Progression



University of Pennsylvania Philadelphia, Pennsylvania  19104
Thomas Jefferson University Philadelphia, Pennsylvania  19107-6541
National Cancer Institute Bethesda, Maryland  20892-1922