Phase IIA Trial Testing Erlotinib as an Intervention Against Intraductal Pancreatic Mucinous Neoplasms
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Reduction in Number of Positive IPMN Celss and Staining Intensity After Treatment
研究概览
简要总结
Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving erlotinib hydrochloride before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. This phase II trial is studying how well erlotinib hydrochloride works in treating patients with pancreatic cancer that can be removed by surgery
详细描述
PRIMARY OBJECTIVES:
I. To test the hypothesis that the activated epidermal growth factor receptor (EGFR) signal transduction biomarker Mucin 5AC (MUC5AC) protein expression within intraductal pancreatic mucinous neoplasm (IPMN) lesions will have greater than zero absolute mean decrease from baseline comparing pre and post 21-42 days of Erlotinib (erlotinib hydrochloride) administration at 100mg orally (PO) once daily (QD).
SECONDARY OBJECTIVES:
I. To test the hypothesis that other correlative IPMN EGF inducible biomarkers will have greater than zero absolute mean decrease from baseline pre and post Erlotinib 100mg PO QD therapy.
II. Safety of Erlotinib treatment. III. To determine Erlotinib pharmacokinetic concentration in plasma and pancreatic tissue at the 100mg/day dose up to 42 days of therapy.
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
- •Confirmed IPMN histological diagnosis, endoscopic ultrasound fine needle aspiration (EUS-FNA) core biopsy tissue specimen with plan for pancreatic surgical resection; histological diagnosis should be within 6 months of entry into protocol
- •Patients must have adequate bone marrow function at study entry
- •White blood cell (WBC) > 3,000
- •Platelets > 100,000/mm^3
- •Hemoglobin > 10 g/dL
- •Plasma creatinine of < 1.6 mg/dL
- •Total bilirubin < 1.5
- •Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 1.5 x upper limit of normal
- •Patients with evidence of obstructive lung disease (forced expiratory volume in one second [FEV1] < 80% predicted and FEV1/forced vital capacity [FVC] ratio < 90% of predicted value) as the etiology of a low diffusing capacity will still be eligible as long as the chest radiograph or computed tomography (CT) does not demonstrate interstitial changes
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- •Women of child-bearing potential and men taking study drug must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation
- •Ability to understand, as well as sign the written informed consent document
- •If a woman of child-bearing potential, must have a negative pregnancy test prior to study entry; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately
排除标准
- •Intake of EGFR antagonist, Erbitux (cetuximab)
- •Previous history of sensitivity to Tarceva (erlotinib hydrochloride), Iressa (gefitinib), or Erbitux, such as a rash that is uncontrollable by topical steroids and/or antibiotics
- •Uncontrollable diarrhea of any cause
- •Active keratoconjunctivitis, or corneal surgery in the past three weeks
- •Participants taking a known cytochrome P450 3A4 (CYP 3A4) inducer (e.g., phenytoin, carbamazepine, St. John's wort, and rifampin) and medications known to be inhibitors or metabolized by CYP3A4; these inhibitors include erythromycin, clarithromycin and ketoconazole, and patients taking them will be excluded since these drugs may be expected to result in altered exposure of Erlotinib
- •Hospitalization within the past 5 years for mania or for bipolar disease
- •Participants may not be receiving any other investigational pharmaceutical agents
- •Women who are breast-feeding should not receive Erlotinib
- •Any medical or psychosocial condition that, in the opinion of the investigator, could jeopardize the subject's participation in and compliance to the study
研究组 & 干预措施
Treatment (enzyme inhibitor therapy)
Patients receive erlotinib hydrochloride PO QD for 21-42 days. Patients then proceed to surgery.
干预措施: erlotinib hydrochloride (Drug)
Treatment (enzyme inhibitor therapy)
Patients receive erlotinib hydrochloride PO QD for 21-42 days. Patients then proceed to surgery.
干预措施: conventional surgery (Procedure)
Treatment (enzyme inhibitor therapy)
Patients receive erlotinib hydrochloride PO QD for 21-42 days. Patients then proceed to surgery.
干预措施: immunohistochemistry staining method (Other)
Treatment (enzyme inhibitor therapy)
Patients receive erlotinib hydrochloride PO QD for 21-42 days. Patients then proceed to surgery.
干预措施: protein expression analysis (Genetic)
Treatment (enzyme inhibitor therapy)
Patients receive erlotinib hydrochloride PO QD for 21-42 days. Patients then proceed to surgery.
干预措施: biopsy (Procedure)
Treatment (enzyme inhibitor therapy)
Patients receive erlotinib hydrochloride PO QD for 21-42 days. Patients then proceed to surgery.
干预措施: pharmacological study (Other)
Treatment (enzyme inhibitor therapy)
Patients receive erlotinib hydrochloride PO QD for 21-42 days. Patients then proceed to surgery.
干预措施: laboratory biomarker analysis (Other)
结局指标
主要结局
Reduction in Number of Positive IPMN Celss and Staining Intensity After Treatment
时间窗: Pre-treatment and post-treatment
Number of participants showed a reduction in number of positive IPMN cells and staining intensity after treatment
次要结局
- Pancreas Calculated Concentration - OSI-774 (ng/g)(20 weeks)
- Plasma Calculated Concentration - OSI-774 (ng/mL)(20 weeks)
- Plasma Calculated Concentration - OSI-420 (ng/mL)(20 weeks)
- Pancreas Calculated Concentration - OSI-420 (ng/g)(20 weeks)
- Number of Participants Reported at Least 1 Adverse Event With a Grade of 3 and Above(Up to 20 weeks)