A Phase II Randomized Trial Comparing a Combination of Abraxane and Gemcitabine Versus Gemcitabine Alone as First Line Treatment in Locally Advanced Unresectable Pancreatic Cancer. GAP (Gemcitabine Abraxane Pancreas) Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 124
- 试验地点
- 38
- 主要终点
- Progression Rate
研究概览
简要总结
Pancreatic cancer is the fourth cause of cancer mortality: there are different treatment approaches to locally advanced pancreatic cancer management.
Generally, gemcitabine alone is considered a reasonable approach for advanced pancreatic cancer patients but we need a chemotherapeutic regimen able to prevent as much as possible a progression of the disease. Nab-paclitaxel (Abraxane) recently demonstrated an interesting activity profile in advanced pancreatic cancer. A combination of Nab-paclitaxel and gemcitabine has been demonstrated superior to gemcitabine alone in metastatic patients.
详细描述
Study population: Locally advanced unresectable pancreatic cancer patients
Elegibility criteria:
- Written informed consent
- Age >18 < 75 years
- Histologically/cytologically confirmed locally advanced, unresectable pancreatic cancer
- At least one lesion measurable with CT or MRI scan
- Performance Status (ECOG) 0-1 at study entry
- Life expectancy of at least 3 months
- Adequate marrow, liver and renal function
- Effective contraception if the risk of conception exists (in the Informed Consent for the patients the descriptions of possible contraceptives is reported
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
- Single (Participant)
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
- •Written informed consent
- •Age >18 < 75 years
- •Histologically/cytologically confirmed locally advanced, unresectable pancreatic cancer
- •At least one lesion measurable with CT or MRI scan
- •Performance Status (ECOG) 0-1 at study entry
- •Life expectancy of at least 3 months
- •Adequate marrow, liver and renal function
- •Effective contraception if the risk of conception exists (in the Informed Consent for the patients the descriptions of possible contraceptives is reported)
排除标准
- •Previous chemotherapy or radiotherapy for pancreatic cancer
- •Severe cardiovascular disease
- •Thrombotic or embolic events
- •Acute or subacute intestinal occlusion or history of inflammatory bowel disease
- •Known hypersensitivity to study drug
- •Known drugs or alcohol abuse
- •Pregnant or breastfeeding women
- •Previous or concurrent malignancy; except for basal or squamous cell skin cancer and/or in situ carcinoma of the cervix, or other solid tumors treated curatively and with evidence of no recurrence for at least 5 years prior to randomization
- •Unable to sign informed consent
研究组 & 干预措施
nab-paclitaxel and gemcitabine
ARM A: nab-paclitaxel 125 mg/mq over 30 min and gemcitabine 1000 mg/mq weekly on days 1, 8 and 15 of a 28-day cycle
干预措施: Nab-paclitaxel and Gemcitabine (Drug)
nab-paclitaxel and gemcitabine
ARM A: nab-paclitaxel 125 mg/mq over 30 min and gemcitabine 1000 mg/mq weekly on days 1, 8 and 15 of a 28-day cycle
干预措施: Gemcitabine (Drug)
Gemcitabine
ARM B: Gemcitabine 1000 mg/mq over 30 minutes on days 1, 8 and 15 of a 28-day cycle.
干预措施: Gemcitabine (Drug)
结局指标
主要结局
Progression Rate
时间窗: progression rate is evaluated after 3 cycles of chemotherapy
Assuming an expected progression rate in the control arm of 40% and an auspicated progression rate in the experimental arm of 20%,with one-tailed alpha=0.05, 80% power, 124 patients are required for the final analysis
次要结局
- Quality of Response(Response to treatment is evaluated according to the RECIST criteria at the end of chemotherapy)
- Esplore the effects of nab-paclitaxel in terms of toxicity(every 3 cycles of chemotherapy)
- Progression Free Survival(time from the start of the treatment until PD or death)
- Overall Survival(the time from randomization to the date of death)