NCT01525771已完成1 期
A Phase I-II Study of Systemic Capecitabine, Cisplatin and Intraperitoneal Docetaxel (XPID) in Patients With Advanced Stomach Cancer With Peritoneal Seeding
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 2
- 主要终点
- Maximum tolerated dose
研究概览
简要总结
A maximum of 8 cycles of chemotherapy will be administered. Depending on patients' tolerability, 8 cycles of chemotherapy will be given to the patients.
详细描述
Single-center, open-label, prospective, single-arm, phase I-II study
About 37 patients (Phase I 18, Phase II 31 (including 12 patients from Phase I)
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
- •Unresectable or metastatic advanced gastric adenocarcinoma confirmed by histology
- •Peritoneal seeding proven by histology or cytology
- •Completion of adjuvant chemotherapy 6 months before the study, or no previous chemotherapy (But, patients who received docetaxel or cisplatin as adjuvant chemotherapy should be excluded)
- •Age 18 to 70 years old
- •Eastern Cooperative Oncology Group performance status <_ 2
- •Estimated life expectancy of more than 3 months
- •Adequate bone marrow function (WBCs>3,000/µL and absolute neutrophil count (ANC) >1,500/µL and platelets>100,000/µL),
- •Adequate renal function: creatinine < 1 x upper normal limit (UNL) or creatinine clearance _> 60ml/min
- •Adequate hepatic function: bilirubin < 1.5 x UNL, AST/ALT levels < 2.5 x UNL, alkaline phosphatase < 5 x UNL (except in case of bone metastasis without any liver disease)
- •Written informed consent
排除标准
- •Contraindication to any drug contained in the chemotherapy regimen
- •Other tumor type than adenocarcinoma
- •Presence or history of 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
- •Other serious illness or medical conditions
结局指标
主要结局
Maximum tolerated dose
时间窗: 1 year
Phase I Study \- Maximum tolerated dose of Intraperitoneal Docetaxel Phase II Study * Progression-free survival rate at 6 months * response rate, time to progression, overall survival
次要结局
- Safety profile(1 year)
- Overall survival(1 year)
- Progression free survival(1 year)
- efficacy(1 year)
研究者
Min-Hee Ryu
Associate Professor
Asan Medical Center
研究点 (2)
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