Trial of Paclitaxel Plus Gemcitabine and Cisplatin in Bladder Cancer

Inclusion Criteria

• •All patients must have adequate physiologic reserves as evidenced by:
• •Life expectancy of at least 12 weeks.
• •Eastern Cooperative Oncology Group (ECOG) performance status of ≤2.
• •No clinical history of heart disease and a normal EKG or an ejection fraction measured by echocardiogram or MUGA scan of at least 45%.
• •Transaminase less than twice the upper limit of normal. Bilirubin \<1.5 mg%.
• •Absolute neutrophil count ≥1500; platelet count ≥100,000.
• •Patients must not have had any previous systemic chemotherapy for bladder cancer, including neoadjuvant or adjuvant treatment given remotely. Gemcitabine/cisplatin is the standard of care for metastatic urothelial cancer. Patients who have received treatment would be either resistant or refractory to additional doses. In addition, they would have residual adverse effects from treatment and would be particularly susceptible to further neuropathic adverse events. Any prior intravesicular therapy is allowed.
• •Women of childbearing potential must have a negative pregnancy test prior to starting therapy. Men and women of childbearing potential must be willing to consent using effective contraceptive while on treatment and for a reasonable period thereafter.
• •Patients must not have an active, or likely to become active, second malignancy.
• •Patients must be at least 6 weeks out from pelvic irradiation, and must not have had more than 10% of the bone marrow irradiated.