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
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 |
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.
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. |
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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 |
Lead Sponsor | Collaborator |
---|---|
Bristol-Myers Squibb | Pierre Fabre Medicament |
United States, Australia, Austria, Canada, France, Greece, Indonesia, Italy, Korea, Republic of, Philippines, Singapore, Spain, Sweden, Switzerland, Thailand,
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 |
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