Phase I/II Study of Oral S-1 Plus Docetaxel in Elderly Patients With Advanced Gastric Cancer
试验速览
- 阶段
- 1 期
- 状态
- 暂停
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
To assess the usefulness of Docetaxel plus S-1 combination chemotherapy based on the antitumor effect and survival period by performing a phase I/II study of this combination in Elderly patients with inoperable or with postoperative gastric cancer.
详细描述
A multicenter Open-label, single-arm, phase I/II clinical trial is conducted on Elderly patients with histological stage IV gastric cancer given Docetaxel plus S-1. The usefulness of this regimens as 1st line therapy for gastric cancer was evaluated by the disease-free survival rate (DFR), overall survival rate (OS), 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
- 76 Years 至 80 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histological diagnosis of gastric adenocarcinoma.
- •Measurable or assessable lesions(Except for Phase I).
- •Age: 76 ~ 80 years.
- •Performance Status (ECOG): 0 ~
- •No prior chemotherapy or only one regimen of previous chemotherapy (with a washout period >4 weeks after the final day of the previous therapy). Adjuvant chemotherapy is not defined as previous therapy.
- •No history of treatment with Docetaxel 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 12,000/mm
- •Hb 10.0 g/dl. Platelet count 100,000/mm
- •GOT and GPT 2.5 times the upper limit of normal (excluding liver metastasis). T-Bil 2.0mg/dl. Creatinine <1.5 mg/dl (but if it is 1.0 ~ 1.5 mg/dl, the dose of S-1 can be decreased according to the dose reduction criteria to allow registration in the trial). 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.
- •Diarrhea (watery stools).
- •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.
研究组 & 干预措施
1
Docetaxel plus S-1
干预措施: Taxotere (Drug)
1
Docetaxel plus S-1
干预措施: TS-1 (Drug)
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.
时间窗: 1-year
次要结局
- Determine the clinical response rate of patients in Phase I setting.(1-year)
- Determine the OS(Overall Survival) and DFS(Disease Free Survival).(2-years)