Vinflunine in Patients With Locally Advanced or Metastatic Transitional Cell Carcinoma of the Urothelium

Bladder Cancer Clinical Trial

Official title:

A Phase II Study of Intravenous (IV) Vinflunine in Patients With Locally Advanced or Metastatic Transitional Cell Carcinoma (TCC) of the Urothelium

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00101608
• Other study ID #: CA183-001
• Status: Completed
• Phase: Phase 2
• First received: January 12, 2005
• Last updated: February 27, 2010
• Start date: January 2005
• Est. completion date: April 2007

Study information

• Verified date: August 2008
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this clinical research study is to learn if vinflunine can shrink or slow the growth of the cancer or increase survival in patients with transitional cell carcinoma of the urothelium. The safety of this treatment will also be studied.

Other known NCT identifiers

• NCT00268424

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: April 2007
• Est. primary completion date: April 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Clinical diagnosis of transitional cell carcinoma of the urothelium that is locally advanced or metastatic (i.e. patients cannot be candidates for local/regional control of disease).

• Relapse or progression within 12.5 months of prior cisplatin or carboplatin containing chemotherapy regimen.

• Adequate performance status (Karnofsky greater or equal to 80).

Exclusion Criteria:

• Receipt of more than 1 prior chemotherapy regimen in any setting.

• Prior discontinuation of platinum due solely to toxicity.

• Current neuropathy greater or equal to CTC grade 2.

• Prior radiation to greater or equal to 30% of bone marrow.

• Inadequate hematologic function: ANC <1,500 cells/mm3, Platelet<100,000 cells/mm3.

• Inadequate hepatic function: total bilirubin > 1.5 times ULN, ALT/AST > 2.5 times ULN or > 5 times ULN in case of liver metastasis.

• Inadequate renal function: creatinine clearance <20 ml/min.

• Prior allergy to any vinca-alkaloid.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bladder Cancer
• Bladder Neoplasms
• Carcinoma
• Carcinoma, Transitional Cell
• Kidney Neoplasms
• Neoplasm, Bladder
• Neoplasms
• Transitional Cell Carcinoma
• Ureter Neoplasms
• Ureteral Neoplasms
• Urinary Bladder Neoplasms

Intervention

Drug:
• vinflunine
solution for injection, IV, 280/320 mg/m2, every 3 wks, variable duration

Locations

Country	Name	City	State
Australia	Local Institution	Adelaide	South Australia
Australia	Local Institution	Liverpool	New South Wales
Australia	Local Institution	Sydney	New South Wales
Australia	Local Institution	Taree	New South Wales
Australia	Local Institution	Waratah	New South Wales
Australia	Local Institution	Westmead	New South Wales
Austria	Local Institution	Linz
Austria	Local Institution	Salzburg
Canada	Local Institution	Edmonton	Alberta
Canada	Local Institution	London	Ontario
Canada	Local Institution	Montreal	Quebec
Canada	Local Insitution	Toronto	Ontario
France	Local Institution	Caen
France	Local Institution	Le Mans Cedex 2
France	Local Institution	Nice
France	Local Institution	Paris
France	Local Institution	Toulouse
Greece	Local Institution	Ilion
Indonesia	Local Institution	Jakarta
Italy	Local Institution	Genova
Italy	Local Institution	Milan
Italy	Local Institution	Roma
Italy	Local Institution	Rome
Italy	Local Institution	Viterbo
Korea, Republic of	Local Institution	Seoul
Philippines	Local Institution	Cebu City
Philippines	Local Institution	Quezon
Philippines	Local Institution	Quezon City
Singapore	Local Institution	Singapore
Spain	Local Institution	Murcia
Spain	Local Institution	Palma De Mallorca
Spain	Local Institution	Santander
Spain	Local Institution	Sevilla
Sweden	Local Institution	Linkoping
Sweden	Local Institution	Uppsala
Switzerland	Local Institution	Aarau
Thailand	Local Institution	Bangkok
United States	Local Institution	Ann Arbor	Michigan
United States	Local Institution	Atlanta	Georgia
United States	Local Institution	Aurora	Colorado
United States	Local Institution	Baltimore	Maryland
United States	Local Institution	Beverly Hills	California
United States	Local Institution	Bronx	New York
United States	Local Institution	Buffalo	New York
United States	Local Institution	Burlington	Massachusetts
United States	Local Institution	Charlotte	North Carolina
United States	Local Institution	Chicago	Illinois
United States	Local Institution	Cincinnati	Ohio
United States	Local Institution	Dallas	Texas
United States	Local Institution	Detroit	Michigan
United States	Local Institution	Durham	North Carolina
United States	Local Institution	Honolulu	Hawaii
United States	Local Institution	Jacksonville	Florida
United States	Local Institution	Joliet	Illinois
United States	Local Institution	Kansas City	Missouri
United States	Local Institution	La Jolla	California
United States	Local Institution	Las Vegas	Nevada
United States	Local Institution	Lebanon	New Hampshire
United States	Local Institution	Los Angeles	California
United States	Local Institution	Louisville	Kentucky
United States	Local Institution	Miami	Florida
United States	Local Institution	Milwaukee	Wisconsin
United States	Local Institution	Nashville	Tennessee
United States	Local Institution	New Haven	Connecticut
United States	Local Institution	New York	New York
United States	Local Institution	Philadelphia	Pennsylvania
United States	Local Institution	Pittsburgh	Pennsylvania
United States	Local Institution	Providence	Rhode Island
United States	Local Institution	Santa Monica	California
United States	Local Institution	Seattle	Washington
United States	Local Institution	St. Louis	Missouri
United States	Local Institution	Stanford	California
United States	Local Institution	Urbana	Illinois
United States	Local Institution	Vallejo	California
United States	Local Institution	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Bristol-Myers Squibb	Pierre Fabre Medicament

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Canada,  France,  Greece,  Indonesia,  Italy,  Korea, Republic of,  Philippines,  Singapore,  Spain,  Sweden,  Switzerland,  Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To estimate the objective response rate in patients with TCC of the urothelium receiving vinflunine, who had evidence of documented progression at any time within 12 months after the last dose of platinum therapy and are not candidates of cystectomy.		10-Apr-2007	No
Secondary	To estimate duration of response, time to response disease control rate, progression free survival, and overall survival in this patient population, and evaluate the safety profile of vinflunine		10-April-2007	Yes

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm