Trial Information

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

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 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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Trial listings updated: June 1, 2008 at 5:45:54 AM