Phase II Trial Evaluating the Combination of Gemcitabine, Trastuzumab and Erlotinib as First-line Chemotherapy in Patients With Metastatic Pancreatic Adenocarcinoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- Disease control rate according to RECIST criteria of the Gemcitabine, Trastuzumab and Erlotinib combination.
研究概览
简要总结
GATE 1 is an open-label, non-comparative, multicentric study evaluating the efficacy and tolerance of the combined use of Gemcitabine, Trastuzumab and Erlotinib as a first-line chemotherapy in metastatic pancreatic cancer patients.
The patients will be treated intravenously with Gemcitabine at a dose of 1000 mg/m2 for 30 min. For the first eight weeks, Gemcitabine will be administered once weekly for 7 weeks followed by one week of rest. Subsequently, Gemcitabine will be administered once weekly for three weeks followed by one week of rest.
Trastuzumab will be administered once a week at a dose of 4 mg/kg over 90 min. at D1 and then at 2 mg/kg over 30 min. for the subsequent infusions.
Erlotinib will be administered orally at a dose of 100 mg/day from C1D1.
The patients will be subjected to research for the EGFR, HER2 and KRAS status.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Metastatic pancreatic adenocarcinoma confirmed by histology
- •Tumor sample available
- •Measurable lesion according to RECIST criteria
- •Performance status ≥ 1
- •Life expectancy > 3 months
- •Hematology: Hb ≥ 9g/dL, neutrophils ≥ 1,500/mm3, platelets ≥ 100,000/mm3
- •Renal function: creatinine ≤ 1.5 x ULN
- •Hepatic function: total bilirubin ≤ 2.5 x ULN, transaminases ≤ 5 x ULN
- •Left ventricular ejection fraction (LVEF) ≥ 50%
- •At least a 6-month delay between the end of any previous gemcitabine-based chemotherapy and diagnosis of metastases
- •Social security
- •Informed consent obtained prior to inclusion.
排除标准
- •Non metastatic advanced local disease
- •Presence of cerebral metastases or symptomatic leptomeningeal carcinomatosis
- •Others cancers except BBC and cervical cancer receiving curative treatment
- •No previous treatment by Erlotinib or Trastuzumab
- •Known severe hypersensitivity to Erlotinib, Trastuzumab, murine proteins or Gemcitabine
- •Presence of significant co-morbidities
- •Concomitant treatment with other experimental products or other anticancer therapies
- •Breastfeeding or pregnant female, or patient of reproductive age not using adequate contraception
- •Legal incapacity or limited legal incapacity
研究组 & 干预措施
Treatment
Gemcitabine - Trastuzumab - Erlotinib
干预措施: Gemcitabine - Trastuzumab - Erlotinib (Drug)
结局指标
主要结局
Disease control rate according to RECIST criteria of the Gemcitabine, Trastuzumab and Erlotinib combination.
时间窗: Every 8 weeks and at the treatment completion
The tumor evaluation will be based on: * Clinical examination * TAP CT-scan or MRI * Tumor marker dosage (CEA and CA 19-9)
次要结局
- Progression free survival(Every 8 weeks and at the treatment completion)
- Overall survival(Every 8 weeks and at treatment completion)