Phase I/II Study of Docetaxel, Cisplatin and 5-fluorouracil(TPF) as 1st-line Chemotherapy in Patients With Metastatic Esophageal Cancer.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 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
A phase I/II study is conducted to determine the maximum-tolerated dose (MTD), dose-limiting toxicity (DLT), and efficacy of a combination chemotherapy using docetaxel, cisplatin and 5-fluorouracil (TPF) in untreated patients with metastatic esophageal cancer. The usefulness of the this regimen is evaluated by response rate, median survival time, and progression free survival.
详细描述
Patients with untreated measurable metastatic esophageal cancer were included in this trial. Patients received this combination chemotherapy repeated every 28 days until progression disease. Starting dose (dose level 1) were docetaxel 50 mg/m2 on day 1, fixed dose intravenously cisplatin (15 mg/m2/day) and continuous infusion 5-FU (800 mg/m2/day) on day 1-4. DLT was defined as follows (according to NCI-CTC version 2.0); Grade 4 neutropenia lasting for more than 4days, Grade 4 anemia and thrombocytopenia, Grade 3 neutropenia accompanied fever (>38℃) , and Grade 3 non-hematological toxicity (except for nausea, appetite loss , general fatigue). Maximal Tolerated Dose (MTD) is determined when the incidence of critical toxicity exceeds 50% at a certain dose level. Response rate will be calculated according to RECIST criteria.
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
- •Histologically confirmed metastatic or recurrent esophageal tumors with no previous treatment for advanced disease.(Except for small cell carcinoma)
- •At least one measurable lesion according to the RECIST criteria. Minimum indicator lesion size: > 10 mm measured by spiral CT or >20mm measured by conventional techniques(Except for Phase I setting).
- •Patients aged between 20 and 75 years, inclusive, at the time of acquisition of informed consent
- •Patients with performance status(ECOG) 0 to 2
- •Abnormal hematologic values (WBC ≥ 3.0 x 109/L, Hemoglobin ≥ 9.5g/dl, platelet count ≥ 100 x 109/L)
- •Creatinine clearance ≥ 60 ml/min, Serum cleatinine ≤ 1.5mg/dl
- •Serum bilirubin ≤ 1.5mg/dl. ALT, AST ≤ 2.5 x upper normal limit (or ≤ 3 x upper normal limit in the case of liver metastases)
- •Patients who have not received cancer therapy (radiotherapy, chemotherapy or immunotherapy)
- •Life expectancy ≥ 3 months
- •Patients who have given written informed consent to participate in this study
排除标准
- •Patients with active multiple cancers; or even if the multiple cancers are metachronous, have a disease-free period of less than 5 years (but excluding cancer in situ and skin cancer) (Except for Phase I setting)
- •Serious, uncontrolled, concurrent infection(s) or illness(es)
- •Patients with no serious concurrent complications (such as heart disease, Intestinal pneumonia)
- •Patients with brain metastasis
- •Patients receiving continuous administration of steroids
- •Patients who have experienced serious drug allergy in the past
- •Patients with retention of body fluid(pleural effusion, ascites, pericardial effusion) necessitating treatment
- •Patients who are pregnant and lactating or hope to become pregnant during the study period
- •Patients with prior Taxan treatment (Paclitaxel, Docetaxel)
- •Patients with edema ≥ grade 2
- •Others, patients judged by the investigator or subinvestigator to be inappropriate as subject
研究组 & 干预措施
1
干预措施: Taxotere (Drug)
1
干预措施: 5-FU (Drug)
1
干预措施: Briplatin (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: one year
次要结局
- Determine the MST(Median Survival Time) and PFS(Progression Free Survival) in Phase II setting.(one year)