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

Bristol-Myers Squibb (BMS)

Status and phase

Completed

Phase 2

Conditions

Bladder Cancer

Ureter Neoplasms

Transitional Cell Carcinoma

Kidney Neoplasms

Neoplasm, Bladder

Bladder Neoplasms

Treatments

Drug: vinflunine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00101608

CA183-001

Details and patient eligibility

About

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.

Enrollment

150 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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.