The purpose of this study is to evaluate the objective response rate and safety in platinum-resistant epithelial ovarian/fallopian tube/primary peritoneal cancer patients treated with vinorelbine and gemcitabine combination chemotherapy.
Other objectives of this study are to evaluate Progression-free survival and measure CA-125 response rate.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
44
Gmcitabine 1000㎎/㎡ mix in normal saline 100ml iv for 30min andVinorelbine 25㎎/㎡ mix in normal saline 50 ml iv for 5-10min on D1 and 8 every 21 days cycle
Gyeonsang National University Hospital
Jinju, South Korea
Seoul St. Mary's hospital
Seoul, South Korea
Seoul St Mary's hospital
Seoul, South Korea
Severance hospital
Seoul, South Korea
Objective response rate (complete response and partial response)
radiologically assessed response every two cycles, according to RECIST ver 1.1 criteria and serologically assessed CA 125 response every two cycles, according to Rustin's criteria
Time frame: 16 weeks
Progression Free Survival
fom the date of enrollment until the date of confimed progressive disease or death
Time frame: 6months
overall survival
from the date of enrollment to death any cause
Time frame: 1year
Frequency and severity of adverse effects
assesed by the NCI-CTCAE ver 3.0
Time frame: every cycle , from enrollment until death
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