Docetaxel is currently one of standard second-line therapy in patients with gastric cancer. As angiogenesis and FGFR pathway has been suggested to be associated with gastric cancer, dovitinib, dual VEGFR and FGFR inhibitor, may have the potential to improve the outcomes of patients with gastric cancer. Therefore, we investigated the combination regimen of docetaxel and dovitinib.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
14
In phase I portion of the study Docetaxel 45-75 mg/m2, intravenous, every 3 weeks Dovitinib 200-500 mg, oral, 5 days on/2 days off In phase II portion of the study Recommended dose of docetaxel and dovitinib in phase I portion will be used.
Asan Medical Center
Seoul, South Korea
Maximum tolerated dose
If dose limiting toxicities are experienced in two or more out of six patients in the cohort (more than 33% of patient cohort), that dose will be defined as the maximum tolerated dose.
Time frame: 6 months
Progression-free survival
Progression-free survival is defined as the time from the first treatment to the onset of progressive disease or to the date of death whichever comes first.
Time frame: 2 year
Response rate
Proportion of patients with complete and partial response according to the Response Evaluation Criteria in Solid Tumors version 1.1
Time frame: 2 year
Toxicity
Adverse events caused by study drugs according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
Time frame: 2 years
Overall survival
Time from start of study treatment to any cause of death
Time frame: 2 years
Biomarker
FGFR2 copy number will be evaluated in blood and tumor tissue. Treatment efficacy including overall response rate, progression-free survival, and overall survival will be compared according to FGFR2 copy number determined by both FISH and real time PCR using TaqMan probe.
Time frame: Baseline and 2 weeks after study treatment
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