Gemcitabine-Carboplatin Versus Gemcitabine-Oxaliplatin in Cisplatin Un-fit Advanced Urothelial Carcinoma: Randomized Phase II Study
Phase 2
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
Advanced Urothelial Carcinoma
Both
Advanced Urothelial Carcinoma
Trial Information
Gemcitabine-Carboplatin Versus Gemcitabine-Oxaliplatin in Cisplatin Un-fit Advanced Urothelial Carcinoma: Randomized Phase II Study
Inclusion Criteria:
- 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 Criteria:
- 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Response rate
Outcome Description:
Response rate based on RECIST 1.1
Outcome Time Frame:
12 weeks
Safety Issue:
No
Authority:
Korea: Food and Drug Administration
Study ID:
UOSG-AMC-1001
NCT ID:
NCT01487915
Start Date:
October 2010
Completion Date:
Related Keywords:
- Advanced Urothelial Carcinoma
- Cisplatin-unfit condition
- Carcinoma
- Carcinoma, Transitional Cell
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