Status:
COMPLETED
Study of Genexol-PM in Patients With Advanced Urothelial Cancer Previously Treated With Gemcitabine and Platinum
Lead Sponsor:
Asan Medical Center
Collaborating Sponsors:
Samsung Medical Center
Kangdong Sacred Heart Hospital
Conditions:
Bladder Cancer
Ureter Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Taxane-based chemotherapy is currently one of the most commonly used regimen for salvage chemotherapy in advanced urothelial carcinoma. In previously untreated patients, single-agent paclitaxel, admin...
Eligibility Criteria
Inclusion
- Histologically confirmed TCC of the urothelial tract (bladder, renal pelvis, or ureter)
- Prior exposure to gemcitabine-platinum regimen as either adjuvant or palliative chemotherapy.
- Unidimensionally measurable disease outside prior radiotherapy ports
- Age 18 years or older
- ECOG performance status of 0\~2
- Life expectancy of at least 3 months
- Adequate BM function (ANC \>1,500/mm3 \& Platelet \>100,000/mm3)
- 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)
- No pre-existing clinically significant grade 2 or greater neuropathy
Exclusion
- Pregnant or lactating patients
- Presence or history of CNS metastasis
- Patients with prior RT to the axial skeleton within 4 weeks of chemotherapy start to greater than 25% of bone marrow
- Any preexisting medical condition of sufficient severity to prevent full compliance with the study, including active infection, active cardiac symptoms
Key Trial Info
Start Date :
December 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT01426126
Start Date
December 1 2007
End Date
August 1 2011
Last Update
December 7 2011
Active Locations (1)
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1
Asan Medical Center
Seoul, South Korea, 138-736