In previous studies, we found that POF (A combination of oxaliplatin, fluorouracil and Paclitaxel) regimen appears to be of good efficacy and is well tolerated in patients with advanced gastric cancer. Apatinib is an orally antiangiogenic agent. It was approved and launched in China in 2014 as a 3rd-line treatment for patients with advanced gastric cancer. Therefore, investigators initialize this dose escalation phase I study to explore the safety of combination of apatinib and POF as first-line treatment for advanced gastric cancer. Investigators will analyze the maximum tolerated dose (MDT) and dose-limiting toxicity (DLT) of apatinib in this study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
Apatinib 250mg p.o. qd in first cohort (3 subjects). 375mg p.o. qd in second cohort (3 subjects). 500mg p.o. qd in third cohort (3 subjects). 625mg p.o. qd in forth cohort (3 subjects); 750mg p.o. qd in fifth cohort (3 subjects). Other Name:
The POF regimen consisted of a 3-hour infusion of paclitaxel (135 mg/m2) followed by oxaliplatin (85 mg/m2) and Calcium Levofolinate (200 mg/m2).Subsequently, a 46-hour infusion of fluorouracil (2400 mg/m2) was administered using an ambulatory pump, repeating the cycle every 14 days.
Rongbo Lin
Fuzhou, Fujian, China
RECRUITINGDose limiting toxicity
Dose limiting toxicity (DLT) is referred to grade 3 non-hematological toxicity or grade 4 hematological toxicity according to NCI CTCAE 4.03 criteria
Time frame: From enrollment to completion of study. Estimated about 12 months.
Maximum tolerance dose
Maximum tolerance dose (MTD) is the dose of treatment in the cohort where there are 2 cases of DTL reported.
Time frame: From enrollment to completion of study. Estimated about 12 months.
Objective response rate
Clinical response of treatment according to RESIST v1.1 criteria (ORR, objective response rate).
Time frame: From enrollment to 3 months after treatment
Progression-free survival
The length of time from enrollment until the time of progression of disease (PFS, progression-free survival).
Time frame: From enrollment to progression of disease. Estimated about 6 months.
Overall survival
The length of time from enrollment until the time of death (OS, overall survival).
Time frame: From enrollment to death of patients. Estimated about 1 year.
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