A single center phase 1b/2 trail to identified suitable dosage and its efficacy of modified FLOT regime in Chinese gastric cancer patients. This trial is designed to identified recommended phase II dose (RP2D) of modified FLOT in Chinese patients, and to evaluate the efficacy of modified FLOT regime as first-line for advanced or metastatic gastric cancer. This trial is in 2 stages: the first stage will establish the maximum tolerated dose (MTD) and RP2D of docetaxel and oxaliplatin in FLOT regime. In the second stage, the efficacy of modified FLOT will be assessed by response rate.
The RP2D of FLOT regime will be established with a standard 3+3 design, starting with the dose of 40mg/m2 docetaxel (dose level 1) and 65mg/m2 oxaliplatin (dose level 1). The plan of dose escalation will be found in following table. Chemotherapy will be administered two-weekly (maximum 12 cycles) until progression of disease, intolerable toxicity or withdraw of patients.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
This is a single-arm study with all patients receiving mFLOT chemotherapy.
Department of Oncology, Ruijin Hospital
Shanghai, China
Maximum tolerated dose and recommended phase II dose of modified FLOT regime
Time frame: 36 months
Objective response rate
Time frame: 36 months
Overall survival
Time frame: 36 months
Progression free survival
Time frame: 36 months
Safety: adverse events as assessed by CTCAE v4.0
Time frame: 36 months
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