A Phase I/II Trial of RAD001/Capecitabine in Refractory Gastric Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 1
- 主要终点
- To determine maximum tolerated dose (MTD) in phase I
研究概览
简要总结
Capecitabine is an oral fluoropyrimidine that has been shown to be effective in the treatment of metastatic gastric and colorectal cancer patients. On the basis of capecitabine-based chemotherapy which is accepted as a standard regimen in gastric cancer, we will perform the phase I/II study with all-oral regimen of RAD001 with capecitabine for these refractory gastric cancer patients.
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 or cytologically proven gastric cancer patients
- •Adequate organ function as defined by the following criteria:
- •A. Serum aspartate transaminase (AST; serum glutamic oxaloacetic transaminase (SGOT)) and serum alanine transaminase (ALT; serum glutamic pyruvic transaminase (SGPT)) ≤ 2.5 x local laboratory upper limit of normal (ULN), or AST and ALT less than or equal to 5 x ULN if liver function abnormalities are due to underlying malignancy B. Total serum bilirubin ≤ 3.0 mg/dL C. Absolute neutrophil count (ANC) ≥1500/µL D. Platelets ≥100,000/µL E. Hemoglobin ≥9.0 g/dL (may be transfused or erythropoietin treated) F. Serum calcium ≤12.0 mg/dL G. Serum creatinine ≤1.5 x ULN
- •Patients with CNS metastasis must have stable neurologic function without evidence of CNS progression within 8 weeks
- •Patients who have failed to at least two previous cytotoxic chemotherapy for advanced gastric cancer (adjuvant treatment will be counted as one regimen if received < 12 months from the start of experimental treatment)
- •At least one measurable lesion by RECIST criteria
- •ECOG PS 0-2
- •Patients with informed consent
排除标准
- •Major surgery or radiation therapy within 4 weeks of starting the study treatment.
- •History of or known carcinomatous meningitis, or evidence of symptomatic leptomeningeal disease on screening CT or MRI scan.
- •Ongoing cardiac dysrhythmias of NCI CTCAE grade ≥
- •Pregnancy or breastfeeding.
- •Prior exposure to the study drug.
- •Patients unable to swallow oral medications.
研究组 & 干预措施
Everolimus
Everolimus (RAD001) dose escalation of capecitabine, everolimus
Capecitabine dose escalation of capecitabine, everolimus
干预措施: Everolimus (RAD001) (Drug)
Everolimus
Everolimus (RAD001) dose escalation of capecitabine, everolimus
Capecitabine dose escalation of capecitabine, everolimus
干预措施: Capecitabine (Drug)
结局指标
主要结局
To determine maximum tolerated dose (MTD) in phase I
时间窗: 1 year
To assess response rate in phase II
时间窗: 1 year
次要结局
未报告次要终点
研究者
Jeeyun Lee
Samsung Medical center
Samsung Medical Center