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

Study Overview
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Brief Summary
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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.

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

Conditions
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Transitional Cell Carcinoma, Bladder Neoplasms, Kidney Neoplasms, Ureter Neoplasms, Bladder Cancer, Neoplasm, Bladder

Intervention / Treatment
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* Drug: vinflunine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: vinflunine<br>* solution for injection, IV, 280/320 mg/m2, every 3 wks, variable duration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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urothelium