NCT01045538已完成1 期
A Phase I/II Study of Vorinostat (Zolinza®) in Combination With Capecitabine (X) and Cisplatin (P) for 1st Line Treatment of Metastatic or Recurrent Gastric Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Phase 1 - maximum tolerated dose, Phase 2 - response rate
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed unresectable or metastatic advanced gastric adenocarcinoma
- •Completion of adjuvant chemotherapy 6 months before the study, or no previous chemotherapy
- •Age 18 to 70 years old
- •Eastern Cooperative Oncology Group (ECOG) performance status 2 or less
- •Estimated life expectancy of more than 3 months
- •Presence of measurable or evaluable disease
- •Adequate bone marrow function (ANC >1,500/µL and platelets>100,000/µL),
- •Adequate renal function: creatinine < 1 x upper normal limit (UNL) or creatinine clearance 60ml/min or less
- •Adequate hepatic function: bilirubin < 1.5 x UNL, aspartate aminotransferase (AST)/alanine aminotransferase (ALT) levels < 2.5 x UNL (< 5 x upper limit of normal for patients with liver involvement of their cancer), alkaline phosphatase < 5 x UNL (except in case of bone metastasis without any liver disease)
- •Written informed consent
排除标准
- •Prior exposure to any histone deacetylase (HDAC) inhibitor (however, valproic acid would be allowed if a 30-day wash-off period is provided.)
- •Previous adjuvant treatment with capecitabine or platinums
- •Contraindication to any drug contained in the chemotherapy regimen
- •Other tumor type than adenocarcinoma
- •Presence or history of central nervous system (CNS) metastasis
- •Gastric outlet or bowel obstruction
- •Evidence of serious gastrointestinal bleeding
- •Peripheral neuropathy > grade 2
- •History of significant neurologic or psychiatric disorders
- •History of another malignancy within the last five years except cured basal cell carcinoma of skin and cured carcinoma in-situ of uterine cervix
- •Pregnant or lactating women, women of childbearing potential not employing adequate contraception
- •Active human immunodeficiency virus (HIV) infection
- •Viral hepatitis infections
- •Other serious illness or medical conditions
研究组 & 干预措施
Vorinostat plus XP
Experimental
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
干预措施: Vorinostat, capecitabine, and cisplatin (Drug)
结局指标
主要结局
Phase 1 - maximum tolerated dose, Phase 2 - response rate
时间窗: 3 weeks for maximum tolerated dose, and 6 months for response rate
次要结局
- Progression-free survival(1 year)
- Overall survival(1 year)
- Toxicity profile(toxicity for each cycle)
研究者
Yoon-Koo Kang
Professor
Asan Medical Center
研究点 (1)
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