NCT00209625已完成1 期
Phase I / II Study of Irinotecan (CPT-11) Combined With l-Leucovorin (l-LV) and 5-FU in Patients With Advanced Colorectal Cancer：Hokkaido Gastrointestinal Cancer Study Group:HGCSG0001
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- objective tumor response
研究概览
简要总结
We performed a phase I/II study of CPT-11/5FU/l-LV in advanced colorectal cancer, to determine the optimal dose of CPT-11 and to estimate the safety and efficacy of this regimen
详细描述
A multicenter Open-label, single-arm, phase I/II clinical trial is conducted on patients with histological stage IV colorectal cancer given irinotecan, leucovorin plus fluorouracil. The usefulness of this regimens as 1st line therapy for colorectal cancer was evaluated by the disease-free survival rate (DFR), 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
- 18 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 colorectral adenocarcinoma.
- •Measurable or assessable lesions.
- •Age: 18 ~ 75 years.
- •Performance Status (ECOG): 0 ~
- •No prior chemotherapy. Adjuvant chemotherapy is not defined as previous therapy.
- •No history of radiotherapy to the abdomen.
- •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 2.5times the upper limit of normal (excluding liver metastasis). T-Bil 2.0mg/dl. Creatinine <1.5 mg/dl 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
- •Gilbert's syndrome.
- •Judged to be ineligible for this protocol by the attending physician.
结局指标
主要结局
objective tumor response
次要结局
- Response duration, time to progression, median survival time, and safety
研究者
研究点 (1)
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