NCT00209677暂停1 期
Phase I/II Study of Oral S-1 Plus Gemcitabine in Patients With Metastatic Pancreatic Cancer
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 暂停
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Determine the DLT(Dose Limiting Toxicity) and MTD(Maximum Tolerated Dose) in Phase I setting.
研究概览
简要总结
To assess the usefulness of Gemcitabine plus S-1 therapy based on the antitumor effect and survival period. By performing a phase I/II study of this combination in patients with inoperable or with postoperative pancreatic cancer.
详细描述
A multicenter Open-label, single-arm, phase I/II clinical trial is conducted on patients with histological stage IV Pancreatic cancer given gemcitabine plus S-1. The usefulness of this regimens as 1st line therapy for pancreatic cancer was evaluated by the disease-free survival(DFS), median survival time (MST), incidence and severity of adverse event.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histological diagnosis of pancreatic adenocarcinoma.
- •Measurable or assessable lesions(Except for Phase I).
- •Age: 20 ~ 75 years.
- •Kar-nofsky Performance Status (KPS) >
- •No prior chemotherapy
- •No history of treatment with gemcitabine or S-
- •No history of radiotherapy to the abdomen.
- •Oral intake of S-1 is possible.
- •Adequate function of major organs (bone marrow, heart, lungs, liver etc.). WBC 3,500/mm3 and Neutrophil 2,000/mm
- •Hb 9.0 g/dl. Platelet count 100,000/mm
- •GOT and GPT 2.5 times the upper limit of normal (excluding liver metastasis). T-Bil 2.0 mg/dl. Creatinine within the upper limit of normal). Normal ECG (not considering clinically unimportant arrhythmias and ischemic changes).
- •Predicted survival for >3 months.
- •Able to give written informed consent.
排除标准
- •Severe pleural effusion or ascites.
- •Metastasis to the central nervous system (CNS).
- •Active gastrointestinal bleeding.
- •Active infection.
- •Liver cirrhosis
- •Uncontrolled ischemic heart disease.
- •Serious complications (such as intestinal paralysis, intestinal obstruction, interstitial pneumonia or pulmonary fibrosis, uncontrolled diabetes mellitus, heart failure, renal failure, or hepatic failure).
- •Active multiple cancer.
- •Severe mental disorder.
- •Pregnancy, possible pregnancy, or breast-feeding.
- •Flucytosine treatment
- •Judged to be ineligible for this protocol by the attending physician.
结局指标
主要结局
Determine the DLT(Dose Limiting Toxicity) and MTD(Maximum Tolerated Dose) in Phase I setting.
Determine the clinical response rate with Recommended dose in Phase II setting.
次要结局
- Determine the clinical response rate of patients in Phase I setting.
- Determine the MST(Median Survival Time) and DFS(Disease Free Survival) in Phase II setting.
研究者
研究点 (1)
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