Status:
UNKNOWN
Gemcitabine-Carboplatin Versus Gemcitabine-Oxaliplatin in Cisplatin-unfit Urothelial Carcinoma
Lead Sponsor:
Asan Medical Center
Conditions:
Advanced Urothelial Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Cisplatin-based chemotherapy is the standard regimen for advanced urothelial carcinoma. But cisplatin-unfit patients account for up to 30-40% of patients in clinical practice. Recently reported phas...
Eligibility Criteria
Inclusion
- Cytologically of histologically confirmed urothelial carcinoma
- Locally advanced or metastatic disease
- Measurable disease according to RECIST v.1.1
- ECOG PS 0-2
- Cisplatin-unfit condition (any of the followings: NYHA functional class 3, creatinine clearance 30-60 ml/min, and ECOG PS=2)
- Adequate organ function
- Chemotherapy-naive
Exclusion
- Histology other than urothelial carcinoma, but squamous cell carcinoma or adenocarcinoma mixed with urothelial carcinoma are allowed
- CNS metastases
- Peripheral neuropathy grade 2 or worse
- Serious medical or surgical conditions
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT01487915
Start Date
October 1 2010
Last Update
September 25 2014
Active Locations (5)
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1
Keimyeong University Dongsan Medical Center
Daegu, South Korea, 700-712
2
Chungnam University Hospital
Daejeon, South Korea, 301-721
3
Korea University Anam Hospital
Seoul, South Korea, 136-705
4
Asan Medical Center
Seoul, South Korea, 138-736