Urinary Tract Treatment Trials

XRP988 plus Cisplatin, or Gemcitabine plus Cisplatin (SLHN 2007-99; EFC 6668 Bladder)

Purpose

This is a study in which the participants are randomly assigned either, XRP988 plus cisplatin, or gemcitabine plus cisplatin. The purpose is to compare the results and safety of the drug XRP9881 plus cisplatin to the drug gemcitabine plus cisplatin in the initial treatment of an advanced stage or metastatic (spreading) urothelial tract or bladder cancer. The primary purpose is to compare overall survival between the two groups. Patients are treated until disease progression, death, or unacceptable side effects occur.

Eligibility Criteria

• Patients with confirmed advanced stage (T4b) or metastatic urothelial tract or bladder cancer of the Transitional Cell Carcinoma (TCC) type.
• No prior chemotherapy given only to relieve symptoms.
• Patients may not participate if their (neo)adjuvant (prior to surgery) chemotherapy ended less than 6 months before relapse.
• It has been more than 6 weeks from prior radiotherapy and more than 3 weeks from surgery to the time that the patient has been randomly assigned their drug.
• Patients may not participate if they have had prior cisplatin as (neo)adjuvant chemotherapy at certain doses. You will have to check with your doctor about how much you have received.

Final eligibility is determined by the research staff.