NCT00944463已完成2 期
Randomized Double-blinded, Placebo-controlled Phase II Trial of Simvastatin and Gemcitabine in Advanced Pancreatic Cancer Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 106
- 试验地点
- 1
- 主要终点
- Time to progression
研究概览
简要总结
The purpose of this study is to determine whether simvastatin is effective in the treatment of advanced pancreatic cancer patients.
详细描述
Randomized double-blinded, placebo-controlled phase II trial of simvastatin and gemcitabine in advanced pancreatic cancer patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years
- •Histologically or cytologically confirmed, metastatic or unresectable pancreatic adenocarcinoma (if repeated biopsy (>3) fails or if biopsy is not feasible, the inclusion of the patient will be determined by the central PI)
- •ECOG performance status of 0~2
- •no radiotherapy within 1 month of the study entry
- •measurable or evaluable lesion according to RECIST criteria
- •no prior history of chemotherapy for pancreatic cancer (gemcitabine-based adjuvant chemotherapy ≥ 12 months from the study entry will be allowed)
- •adequate marrow, hepatic, renal and cardiac functions (absolute neutrophil count ≥ 1.5 x 109/L; platelet count ≥ 75 x 109/L, serum creatinine ≤ 1.5 x ULN), serum aspartate aminotransferase/alanine aminotransferase ≤ 5 x ULN or ≤ 10 x ULN if liver abnormalities are due to underlying malignancy; total bilirubin ≤ 2.0 x ULN
- •written informed consent must be provided
排除标准
- •severe co-morbid illness and/or active infections
- •pregnant or lactating women
- •active CNS metastases not controllable with radiotherapy or corticosteroids A.patients with symptoms suggestive of CNS metastases must undergo radiologic evaluation to rule out metastases B.patients with known, asymptomatic CNS lesions are permitted
- •known history of hypersensitivity to study drugs
- •patients who are currently on statin therapy or has taken statin as lipid lowering agents within 1 year of the study entry
研究组 & 干预措施
Gemcitabine+simvastatin
Experimental
Gemcitabine and simvastatin
干预措施: Gemcitabine+simvastatin (Drug)
Gemcitabine+Placebo
Placebo Comparator
Gemcitabine plus Placebo
干预措施: Gemcitabine+Placebo (Drug)
结局指标
主要结局
Time to progression
时间窗: Every 2 cycles until progression
次要结局
- Safety profiles of gemcitabine/simvastatin(Every cycle until progression)
- Response rate(Every 2 cycles until progression)
- Duration of response(Every 2 cycles until progression)
- Overall survival(Every 3 months)
- Correlative analyses(after completion of accrual)
研究者
Young Suk Park
professor
Samsung Medical Center
研究点 (1)
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