This study aims to assess objective response rate of modified FOLFIRINOX in advanced urachaus cancer. Patients with locally advanced, recurrent, or metastatic urachal carcinoma of bladder, urachal will be enrolled this study. Modified version of FOLFIRINOX(Oxaliplatin 85 mg/m 2, Leucovorin 400mg/m2 , irinotecan 150mg/m2 and 5-FU 2400mg/m2) with prophylactic pegateograstim will be continued till progression, unacceptable toxicity, or till 12 cycles (24 weeks). Study drugs can be administered after 12 cycles to the subjects with benefit from study medication. Response evaluation will be done every 6 weeks.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
35
oxaliplatin 85 mg/m2 IV over 2 hours leucovorin 400 mg/m2 over 2 hours irinotecan 150 mg/m2 over 90 min, 5-FU continuous infusion 2400 mg/m2 continuous infusion over 46 hours
Asan Medical Center
Seoul, South Korea
RECRUITINGObjective response rate
Objective response rate
Time frame: up to 2 years
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: every 2 weeks up to 30 weeks.
Progression-free survival (PFS)
Progression-free survival (PFS)
Time frame: up to 2years.
Overall survival (OS),
Overall survival (OS),
Time frame: up to 5 years.
Incidence of febrile neutropenia
Incidence of febrile neutropenia
Time frame: After study completion (an average of 2 year)
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