There is scientific rationale for exploring the role of vorinostat, histone deacetylase inhibitor with capecitabine (X) and cisplatin (P), one of standard chemotherapy in patients with advanced gastric cancer. XP is a new standard of care in advanced gastric cancer (AGC) and vorinostat is a novel targeted agent that prevents tumor cell proliferation, survival and angiogenesis through histone deacetylase inhibition.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
45
Vorinostat 200\~400mg per day on day1-day14 combined with capecitabine 800-1,000mg/m2/dose, BID on day1-day14, and cisplatin 60-80mg/m2 on day 1
Asan Medical Center
Seoul, South Korea
Phase 1 - maximum tolerated dose, Phase 2 - response rate
Time frame: 3 weeks for maximum tolerated dose, and 6 months for response rate
Toxicity profile
Time frame: toxicity for each cycle
Progression-free survival
Time from first administration of study drug to disease progression or any cause of death
Time frame: 1 year
Overall survival
Time from first administration of study drug to any cause of death
Time frame: 1 year
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