A maximum of 8 cycles of chemotherapy will be administered. Depending on patients' tolerability, 8 cycles of chemotherapy will be given to the patients.
Single-center, open-label, prospective, single-arm, phase I-II study About 37 patients (Phase I 18, Phase II 31 (including 12 patients from Phase I)
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
37
The study medication will be administered every 3 weeks for a maximum of 8cycles. A study medication will be given to the patients. * Docetaxel (-1 to 3 level)mg/m2 IV(D1) every 21 days (-1 level: 40, 1 level: 60, 2 level: 80, 3 level: 100) * Xeloda 937.5 mg/m2/ day PO, twice a day(D1-D14) every 21 days * Cisplatin 60mg/m2 IV (D1) every 21 days
Asan Medical Center
Seoul, South Korea
Maximum tolerated dose
Phase I Study \- Maximum tolerated dose of Intraperitoneal Docetaxel Phase II Study * Progression-free survival rate at 6 months * response rate, time to progression, overall survival
Time frame: 1 year
Safety profile
Time frame: 1 year
Overall survival
Time frame: 1 year
Progression free survival
Time frame: 1 year
efficacy
Time frame: 1 year
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