INST 0802: Phase II Trial of Combination Irinotecan, Oxaliplatin and Cetuximab for Patients With Locally Advanced or Metastatic Pancreatic Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 5
- 主要终点
- Overall Response Rate (ORR)
研究概览
简要总结
This phase II trial studies the side effects and how well irinotecan hydrochloride, oxaliplatin and cetuximab work in treating patients with unresectable or metastatic pancreatic cancer. Irinotecan hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving irinotecan hydrochloride together with oxaliplatin and cetuximab may kill more tumor cells.
详细描述
The investigators will evaluate the side effects and how well irinotecan hydrochloride, oxaliplatin and cetuximab work in treating patients with unresectable or metastatic pancreatic cancer. Irinotecan hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving irinotecan hydrochloride together with oxaliplatin and cetuximab may kill more tumor cells.
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
- •All patients, 18 years of age or older, with histology proven pancreatic cancer are eligible.
- •Patients must have a life expectancy of at least 12 weeks.
- •Patients must have a Zubrod performance status of 0-
- •Patients must sign an informed consent.
- •Patients should have adequate bone marrow function defined by an absolute peripheral granulocyte count of >= 1,500 or cells/mm3 and platelet count >= 60,000/mm3 and absence of a regular red blood cell transfusion requirement.
- •Patients should have adequate hepatic function with a total bilirubin <= 4.0 mg/dl, could be <= 10 mg/ml if biliary drainage tube is placed and functional in a newly diagnosed patient, and SGOT or SGPT <= four times the upper limit of normal, and adequate renal function as defined by a serum creatinine <= 1.5 x upper limit of normal.
- •For patients that had been treated with one of the study medications will be allowed as long as the treatment did not contain more than 2 study medications at the same time. For example, irinotecan and capecitabine combination will be allowed but not irinotecan and cetuximab. Similarly, gemcitabine with cetuximab will be allowed but not gemcitabine, oxaliplatin and cetuximab. Treated with irinotecan alone followed by oxaliplatin will be allowed but not when irinotecan was in combination with oxaliplatin.
- •Patients are allowed to have up to 2 prior treatments. The protocol will also include chemotherapy naïve patients.
排除标准
- •Patients with symptomatic brain metastases are excluded from this study.
- •Pregnant women or nursing mothers are not eligible for this trial. Patients of child bearing potential must use adequate contraception.
- •Patients may receive no other concurrent chemotherapy or radiation therapy during this trial.
- •Patients with severe medical problems such as uncontrolled diabetes mellitus or cardiovascular disease or active infections are not eligible for this trial.
- •Known hypersensitivity reaction to any of the study medications.
研究组 & 干预措施
Irinotecan, oxaliplatin, and cetuximab
The goal is to administer at least 4 cycles to each patient, but treatment may stop earlier if the treating physician deems stopping to be in the best interest of the patient. Repeated treatment may be given to patients who benefit (either complete or partial response or stabilization of disease)
干预措施: Irinotecan, oxaliplatin, and cetuximab (Drug)
结局指标
主要结局
Overall Response Rate (ORR)
时间窗: 2 years
ORR is evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.1). Target lesions are assessed by computerized tomography (CT): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient decrease in the sum of the longest diameter of target lesions to qualify for PR nor sufficient increase in the sum of the longest diameter of target lesions to qualify for Progressive Disease; Progressive Disease (PD), 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. ORR is the percentage of patients who experienced a CR + the percentage of patients who experienced a PR.
次要结局
- Toxicity(2 years)