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

NCT01437488 | Completed Phase 2 Results DMC

• 3 other identifiers: 11D.3922011-52JT 2205
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Urothelial Carcinoma

Keywords

Urothelial carcinoma; Urothelial cancer

Outcome Measures

Primary Outcomes (1)

• 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)

  Every 3 cycles or 63 days

Secondary Outcomes (3)

• Overall Survival

  At 12 months

• Progression Free Survival

  Every 3 cycles or 63 days

• Number of Participants Who Tolerated Cabazitaxel

  Up to 30 days after completion of study treatment

Study Arms (1)

Cabazitaxel

EXPERIMENTAL

Cabazitaxel following platinum-based chemotherapy

Drug: Cabazitaxel; Drug: Neulasta; Procedure: CT Scan; Biological: Blood Draw

Interventions

Cabazitaxel DRUG

* 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

Also known as: XRP-6258, Jevtana

Cabazitaxel

Neulasta DRUG

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

Also known as: Pegfilgrastim

Cabazitaxel

CT Scan PROCEDURE

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

Also known as: X-ray computed tomography

Cabazitaxel

Blood Draw BIOLOGICAL

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

Also known as: Venipuncture

Cabazitaxel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sidney Kimmel Cancer Center at Thomas Jefferson University: lead
• Sanofi: collaborator

Study Sites (3)

National Cancer Institute

Bethesda, Maryland, 20892, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Related Links

• Thomas Jefferson University Hospital
• Center for Cancer Research, National Cancer Institute
• Abramson Cancer Center of the University of Pennsylvania

MeSH Terms

Conditions

Carcinoma, Transitional Cell

Interventions

cabazitaxel; XRP6258; pegfilgrastim; Tomography Scanners, X-Ray Computed; Blood Specimen Collection; Phlebotomy

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Equipment and Supplies; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Therapeutics

Results Point of Contact

• Title: Dr. Jean Hoffman-Censits
• Organization: Sidney Kimmel Cancer Center at Thomas Jefferson University

jean.hoffman-censits@jefferson.edu

215 955-8874

Study Officials

• Jean Hoffman-Censits, MD

  Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2011
• First Posted: September 21, 2011
• Study Start: February 16, 2012
• Primary Completion: August 4, 2014
• Study Completion: March 30, 2017
• Last Updated: May 4, 2025
• Results First Posted: August 9, 2017

Record last verified: 2025-05

Locations

US (3)