Study of Genexol-PM in Patients With Advanced Urothelial Cancer Previously Treated With Gemcitabine and Platinum

Launched by ASAN MEDICAL CENTER · Aug 30, 2011

Keywords

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Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Histologically confirmed TCC of the urothelial tract (bladder, renal pelvis, or ureter)
• • 2. Prior exposure to gemcitabine-platinum regimen as either adjuvant or palliative chemotherapy.
• • 3. Unidimensionally measurable disease outside prior radiotherapy ports
• • 4. Age 18 years or older
• • 5. ECOG performance status of 0\~2
• • 6. Life expectancy of at least 3 months
• • 7. Adequate BM function (ANC \>1,500/mm3 \& Platelet \>100,000/mm3)
• • 8. Adequate hepatic function (Bilirubin no greater than 2 times upper limit of normal (ULN) \& AST or ALT no greater than 2.5 times ULN), and renal function (creatinine \<1.5 X times ULN)
• • 9. No pre-existing clinically significant grade 2 or greater neuropathy
• Exclusion Criteria:
• • 1. Pregnant or lactating patients
• • 2. Presence or history of CNS metastasis
• • 3. Patients with prior RT to the axial skeleton within 4 weeks of chemotherapy start to greater than 25% of bone marrow
• • 4. Any preexisting medical condition of sufficient severity to prevent full compliance with the study, including active infection, active cardiac symptoms