First-Line Treatment of Advanced Bladder Cancer Randomized vs. Gemcitabine ± Vinflunine in Patients Ineligible to Receive Cisplatin-Based Therapy

Inclusion Criteria:

• Clinical diagnosis of transitional cell carcinoma of the urothelium that is locallyadvanced or metastatic

• Ineligible for cisplatin-based therapy because of at least one of the following twomedical conditions:

• Calculated creatinine clearance ≤60 mL/min: OR

• New York Heart Association Classification Stage III-IV Congestive Heart Failure

• Measurable disease documented by imaging with at least one uni-dimensional lesion

• Adequate performance status (ECOG 0, 1, or 2)

• Men and women ≥18 years of age

Exclusion Criteria:

• Patients in whom radiation or surgery is indicated

• Current neuropathy ≥ CTCAE grade 3

• Prior radiation to ≥ 30% of bone marrow

• Inadequate renal function: serum creatinine clearance ≤ 20 mL/min

• Prior allergy to any vinca alkaloid