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.
A Phase II Study of Intravenous (IV) Vinflunine in Patients With Locally Advanced or Metastatic Transitional Cell Carcinoma (TCC) of the Urothelium
Transitional Cell Carcinoma, Bladder Cancer, Bladder, Kidney and Ureter Neoplasms
Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
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 doese 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
Eligibility & Criteria
- Ages Eligible for Study: 18 Years and above
- Genders Eligible for Study: Both
- 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).
- 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.
- Local Institution, Sydney, New South Wales, Australia
- Local Institution, Westmead, New South Wales, Australia
- Local Institution, Liverpool, New South Wales, Australia
- Local Institution, Waratah, New South Wales, Australia
- Local Institution, Taree, New South Wales, Australia
- Local Institution, Adelaide, South Australia, Australia
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