NCT01543412已完成2 期
Folfiri as Second-Line Chemotherapy for Advanced Pancreatic Cancer. A GISCAD Phase II Study
Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente9 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2010年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 9
- 主要终点
- Overall Response Rate (RECIST Criteria)
研究概览
简要总结
No validated second-line chemotherapy for the treatment of locally advanced/metastatic pancreatic cancer is actually available,after the failure of a gemcitabine(+/- Cisplatin or Oxaliplatin)-based regimen.
Irinotecan seems to be a moderately active drug in the treatment of this disease Recently was reported some interesting results using a potentially non -cross resistant regimen (FOLFIRI) which could be useful even as second-line chemotherapy.
An exploratory study in this setting seem warranted.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Signed written informed consent prior to beginning protocol specific procedures
- •Previous chemotherapy with Gemcitabine plus or less Platinoids
- •Previous gemcitabine delivered as a radiosensitizer for locally advanced disease, followed or not by a gemcitabine plus or less platinoids as maintenance or disease progression is allowed.
- •Male or female less than 75 years of age
- •Diagnosis of histologically or cytologically confirmed adenocarcinoma of the pancreas
- •Locally advanced (non-resectable) or metastatic pancreatic cancer
- •Presence of at least one uni-dimensional indicator lesion measurable by CT scan or MRI in not an irradiated area
- •ECOG performance status 0 to 1 at study entry
- •Life expectancy: more than 3 months
- •Neutrophils more than 1.5 x 109L, platelets more than 100 x 109L, and hemoglobin more than 10 gdL
- •Bilirubin level either normal or less than 1.5 x ULN
- •ASAT and ALAT normal or less than 2.5 x ULN (normal or less than 5 x ULN if liver metastasis are present)
- •Serum creatinine less than 1.5 x ULN
- •Amylase normal or less than 1.5 ULN
- •Effective contraception for both male and female patients if the risk of conception exists
- •Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be assessed with the patient before registration in the trial
排除标准
- •Brain metastases
- •Previous treatment with irinotecan or fluoropyrimidines
- •Significant cardiovascular disease: clinically relevant coronary artery disease or a history of a myocardial infarction within the last 6 months
- •Significant gastrointestinal abnormalities
- •Gilbert's Syndrome
- •Any uncontrolled infections
- •Known HIV infection
- •Radiotherapy within 4 weeks prior to study entry
- •Any investigational agents 4 weeks prior to entry
- •Known grade 3 or 4 allergic reaction to any of the components of the treatment
- •Known drug abuse or alcohol abuse
- •Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent
- •Women who are pregnant or breastfeeding
- •Any concurrent malignancy other than non-melanoma skin cancer, or carcinoma in situ of the cervix.
- •Legal incapacity or limited legal capacity
研究组 & 干预措施
FOLFIRI
Experimental
Folfiri consist of Irinotecan 180 mg/m2 iv on day 1, Leucovorin(l-form) 200 mg/m2 iv on day 1and 2, 5-FU 400 mg/m2 iv bolus on day 1and 2, 5-FU 600 mg/m2 iv by ci for 22 hours on day 1 and 2, repeated every 2 wks The use of antiemetic prophylaxis was decided locally.
干预措施: FOLFIRI (Drug)
结局指标
主要结局
Overall Response Rate (RECIST Criteria)
时间窗: 2 years
time from randomization date to date of death from any cause
次要结局
- Safety and tolerability; Safety (CTC criteria - version 3.0)(18 months)
- Overall survival (OS)(time from first cycle to death)
- Progression Free Survival(time from first cycle to progression or death)
研究者
研究点 (9)
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Folfiri as Second-Line chemotherapy for Advanced Pancreatic cancer:a GISCAD Phase II study - SLAP (Second Line Advanced Pancreas)Subjects enrolled in this study must have histologically confirmed locally advanced or metastatic pancreatic adenocarcinoma. They must have been received a first-line chemotherapy (one line only) with Gemcitabin +/Platinoid(Cisplatin,Oxaliplatin,Carboplatin)MedDRA version: 14.1Level: LLTClassification code 10013250Term: Disorder pancreasSystem Organ Class: 10017947 - Gastrointestinal disordersEUCTR2008-004637-16-ITGISCAD
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