Trial Information

Summary: SWOG S0306: A Phase II Study of Irinotecan in Patients with Advanced Transitional Cell Carcinoma of the Urothelium

Participants will receive the drug Irinotecan IV once every 3 weeks.

Patient Inclusion Criteria:

• Transitional cell cancer, Stage T2-4, N0-3, M1, of the urothelial tract not curable by surgery or radiation therapy.
• Stage T2-4, N+, M0 with inoperable disease are also eligible.
• Must have measurable disease
• Must have failed or recurred after a regimen containing a platinum based drug.

Patient Exclusion Criteria:

• No prior treatment with irinotecan or topotecan.
• Use of St. John's Wort within 14 days before registration.
• Anti-convulsant use within 7 days before registration.
• Pregnant or nursing females.
• Uncontrolled CNS metastasis or life-threatening concurrent medical condition.
• No prior cancer except skin or cervical cancer or cancer from which pt. has been disease free for 5 years.

Intervention Type: Drug

Condition: Transitional cell cancer of the urothelial tract (bladder, renal pelvis, ureter, urethra)

If you would like to learn more about participating in this study, please send an e-mail message using the form below.