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

Primary Purpose

Transitional Cell Carcinoma, Bladder Neoplasms, Kidney Neoplasms

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
vinflunine
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Transitional Cell Carcinoma focused on measuring urothelium

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

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Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
January 12, 2005
Last Updated
February 27, 2010
Sponsor
Bristol-Myers Squibb
Collaborators
Pierre Fabre Medicament
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1. Study Identification

Unique Protocol Identification Number
NCT00101608
Brief Title
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

2. Study Status

Record Verification Date
August 2008
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
April 2007 (Actual)
Study Completion Date
April 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Bristol-Myers Squibb
Collaborators
Pierre Fabre Medicament

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Transitional Cell Carcinoma, Bladder Neoplasms, Kidney Neoplasms, Ureter Neoplasms, Bladder Cancer, Neoplasm, Bladder
Keywords
urothelium

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
vinflunine
Intervention Description
solution for injection, IV, 280/320 mg/m2, every 3 wks, variable duration
Primary Outcome Measure Information:
Title
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.
Time Frame
10-Apr-2007
Secondary Outcome Measure Information:
Title
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
Time Frame
10-April-2007

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
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Local Institution
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Beverly Hills
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California
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United States
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Local Institution
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La Jolla
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California
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United States
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Local Institution
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Los Angeles
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California
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United States
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Santa Monica
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California
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United States
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Stanford
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California
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United States
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Vallejo
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California
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United States
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Aurora
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Colorado
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United States
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New Haven
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Connecticut
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United States
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Washington
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District of Columbia
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United States
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Jacksonville
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Florida
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United States
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Miami
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Florida
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United States
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Atlanta
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Georgia
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United States
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Honolulu
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Hawaii
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Chicago
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United States
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Joliet
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Illinois
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United States
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Urbana
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Illinois
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United States
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Louisville
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Baltimore
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Burlington
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Ann Arbor
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Detroit
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Lebanon
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Bronx
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Buffalo
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Charlotte
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Durham
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Providence
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Milwaukee
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Liverpool
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Australia
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Sydney
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Australia
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Taree
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Australia
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Waratah
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Australia
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Westmead
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Australia
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Adelaide
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Australia
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Linz
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Austria
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Salzburg
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Austria
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Edmonton
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Canada
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London
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Toronto
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Montreal
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Canada
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Caen
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France
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Le Mans Cedex 2
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France
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Nice
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France
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Paris
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France
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Toulouse
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France
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Ilion
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Greece
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Jakarta
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Indonesia
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Genova
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Italy
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Milan
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Italy
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Roma
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Italy
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Rome
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Italy
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Viterbo
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Italy
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Seoul
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Korea, Republic of
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Cebu City
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Philippines
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Quezon City
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Philippines
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Quezon
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Philippines
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Singapore
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Singapore
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Murcia
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Spain
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Palma De Mallorca
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Spain
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Santander
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Spain
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Sevilla
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Spain
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Linkoping
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Sweden
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Uppsala
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Sweden
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Aarau
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Switzerland
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Bangkok
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Thailand

12. IPD Sharing Statement

Learn more about this trial

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

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