Phase I/II Study of Biweekly Administration Regimen of Paclitaxel Combined With CPT-11 in Patients With Second Line Chemotherapy of Inoperable or Recurrent Gastric Cancer(GC).
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 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. 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 CPT-11 and Paclitaxel in pre-treated patients with metastatic gastric 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 pre-treated measurable metastatic gastric cancer were included in this trial. Patients received this combination chemotherapy repeated every 28 days until progression disease. Starting dose (dose level 1) were CPT-11 80 mg/m2 on day 1 and 15, Paclitaxel 60 mg/m2 on day 1 and 15. DLT was defined as follows (according to NCI-CTC version 2.0); Grade 4 neutropenia, thrombocytopenia(≥25000), Grade 3 neutropenia accompanied fever (>38℃) , and Grade 3 non-hematological toxicity (except for nausea, vomit, appetite loss , general fatigue, alopecia). 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
- — 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed metastatic or recurrent gastric cancer with prior treatment for advanced disease.
- •Patients who have received 1cycle cancer therapy (radiotherapy, chemotherapy or chemoradiotherapy) given > 4 weeks prior to the beginning of study therapy
- •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 ≥ 3.5 x 109/L, Hemoglobin ≥ 9.0g/dl, platelet count ≥ 100 x 109/L)
- •Serum cleatinine ≤ 1.5mg/dl
- •Serum bilirubin ≤ 1.5mg/dl. ALT, AST ≤ 2.0 x upper normal limit (or ≤ 3 x upper normal limit in the case of liver metastases)
- •Normal ECG
- •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 Liver cirrhosis
- •Patients with fresh hemorrhage from the gastrointestinal tract
- •Patients with poorly controlled diabetes or are treated by continuous use of insulin
- •Patients with concurrent psychiatric disease or psychotic symptoms, and judged to have difficulties participating in the study
- •Patients with retention of body fluid(pleural effusion, ascites, pericardial effusion) necessitating treatment
- •Patients with diarrhea (watery stool)
- •Patients with infection, intestinal palsy or intestinal occlusion
- •Patients with brain metastasis
- •Patients with Gilbert syndrome
- •Patients who have experienced serious drug allergy in the past
- •Patients who are pregnant and lactating or hope to become pregnant during the study period
- •Patients with prior Taxan (Paclitaxel, Docetaxel) or CPT-11 treatment
- •Patients with neuropathy ≥ grade 2
- •Others, patients judged by the investigator or subinvestigator to be inappropriate as subject
研究组 & 干预措施
1
Paclitaxel+Irinotecan
干预措施: Taxol (Drug)
1
Paclitaxel+Irinotecan
干预措施: Campt, Topotesin (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 MST(Median Survival Time) and PFS(Progression Free Survival) in Phase II setting.(2-years)
- Determine the clinical response rate of patients in Phase I setting.(1-year)