Clinical trial NCT00101608: Vinflunine in Patients With Locally Advanced or Metastatic Transitional Cell Carcinoma of the Urothelium
Official title: A Phase II Study of Intravenous (IV) Vinflunine in Patients With Locally Advanced or Metastatic Transitional Cell Carcinoma (TCC) of the Urothelium
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Transitional Cell Carcinoma
Bladder Neoplasms
Kidney Neoplasms
Ureter Neoplasms
Bladder Cancer
Neoplasm, Bladder
Keywords: urothelium
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
Collaborators: name: Pierre Fabre Medicament
First posted: 2005-01-13
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: 10-Apr-2007
Secondary outcomes:
measure: 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
timeFrame: 10-April-2007
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: Local Institution
state: California
city: La Jolla
country: United States
facility: Local Institution
state: California
city: Los Angeles
country: United States
facility: Local Institution
state: California
city: Santa Monica
country: United States
facility: Local Institution
state: California
city: Stanford
country: United States
facility: Local Institution
state: California
city: Vallejo
country: United States
facility: Local Institution
state: California
city: Aurora
country: United States
facility: Local Institution
state: Colorado
city: New Haven
country: United States
facility: Local Institution
state: Connecticut
city: Washington
country: United States
facility: Local Institution
state: District of Columbia
city: Jacksonville
country: United States
facility: Local Institution
state: Florida
city: Miami
country: United States
facility: Local Institution
state: Florida
city: Atlanta
country: United States
facility: Local Institution
state: Georgia
city: Honolulu
country: United States
facility: Local Institution
state: Hawaii
city: Chicago
country: United States
facility: Local Institution
state: Illinois
city: Joliet
country: United States
facility: Local Institution
state: Illinois
city: Urbana
country: United States
facility: Local Institution
state: Illinois
city: Louisville
country: United States
facility: Local Institution
state: Kentucky
city: Baltimore
country: United States
facility: Local Institution
state: Maryland
city: Burlington
country: United States
facility: Local Institution
state: Massachusetts
city: Ann Arbor
country: United States
facility: Local Institution
state: Michigan
city: Detroit
country: United States
facility: Local Institution
state: Michigan
city: Kansas City
country: United States
facility: Local Institution
state: Missouri
city: St. Louis
country: United States
facility: Local Institution
state: Missouri
city: Las Vegas
country: United States
facility: Local Institution
state: Nevada
city: Lebanon
country: United States
facility: Local Institution
state: New Hampshire
city: Bronx
country: United States
facility: Local Institution
state: New York
city: Buffalo
country: United States
facility: Local Institution
state: New York
city: New York
country: United States
facility: Local Institution
state: New York
city: Charlotte
country: United States
facility: Local Institution
state: North Carolina
city: Durham
country: United States
facility: Local Institution
state: North Carolina
city: Cincinnati
country: United States
facility: Local Institution
state: Ohio
city: Philadelphia
country: United States
facility: Local Institution
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Local Institution
state: Pennsylvania
city: Providence
country: United States
facility: Local Institution
state: Rhode Island
city: Nashville
country: United States
facility: Local Institution
state: Tennessee
city: Dallas
country: United States
facility: Local Institution
state: Texas
city: Seattle
country: United States
facility: Local Institution
state: Washington
city: Milwaukee
country: United States
facility: Local Institution
state: Wisconsin
city: Liverpool
country: Australia
facility: Local Institution
state: New South Wales
city: Sydney
country: Australia
facility: Local Institution
state: New South Wales
city: Taree
country: Australia
facility: Local Institution
state: New South Wales
city: Waratah
country: Australia
facility: Local Institution
state: New South Wales
city: Westmead
country: Australia
facility: Local Institution
state: New South Wales
city: Adelaide
country: Australia
facility: Local Institution
state: South Australia
city: Linz
country: Austria
facility: Local Institution
city: Salzburg
country: Austria
facility: Local Institution
city: Edmonton
country: Canada
facility: Local Institution
state: Alberta
city: London
country: Canada
facility: Local Institution
state: Ontario
city: Toronto
country: Canada
facility: Local Insitution
state: Ontario
city: Montreal
country: Canada
facility: Local Institution
state: Quebec
city: Caen
country: France
facility: Local Institution
city: Le Mans Cedex 2
country: France
facility: Local Institution
city: Nice
country: France
facility: Local Institution
city: Paris
country: France
facility: Local Institution
city: Toulouse
country: France
facility: Local Institution
city: Ilion
country: Greece
facility: Local Institution
city: Jakarta
country: Indonesia
facility: Local Institution
city: Genova
country: Italy
facility: Local Institution
city: Milan
country: Italy
facility: Local Institution
city: Roma
country: Italy
facility: Local Institution
city: Rome
country: Italy
facility: Local Institution
city: Viterbo
country: Italy
facility: Local Institution
city: Seoul
country: Korea, Republic of
facility: Local Institution
city: Cebu City
country: Philippines
facility: Local Institution
city: Quezon City
country: Philippines
facility: Local Institution
city: Quezon
country: Philippines
facility: Local Institution
city: Singapore
country: Singapore
facility: Local Institution
city: Murcia
country: Spain
facility: Local Institution
city: Palma De Mallorca
country: Spain
facility: Local Institution
city: Santander
country: Spain
facility: Local Institution
city: Sevilla
country: Spain
facility: Local Institution
city: Linkoping
country: Sweden
facility: Local Institution
city: Uppsala
country: Sweden
facility: Local Institution
city: Aarau
country: Switzerland
facility: Local Institution
city: Bangkok
country: Thailand
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: