UPCC 10219: Phase II Study Of Stromal Changes Detected By DCE- and DW-MRI In Response To PEGPH20 Combined With Chemotherapy In Subjects With Locally-Advanced Pancreatic Cancer
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Change in lesion size
研究概览
简要总结
This research study is being conducted to determine the effects of PEGPH20 plus chemotherapy treatment on the MRI characteristics of locally advanced pancreatic cancer patient tumors. Subjects will received Gemcitabine, Abraxane and PEGPH20.
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
- •Signed Informed Consent Form
- •Capable of giving informed consent.
- •Ability and willingness to comply with the protocol including all scheduled MRI studies and paired tumor biopsies
- •Aged ≥ 18 years.
- •borderline or unresectable pancreatic adenocarcinoma without distant metastatic disease.
- •ECOG PS of 0 or 1
- •Must have adequate organ and hematopoietic function
- •Female and Males must use an approved contraceptive method
排除标准
- •Received prior therapy for pancreatic adenocarcinoma
- •History of deep vein thrombosis (DVT) or pulmonary embolism (PE)
- •Contraindication to therapeutic anticoagulation or heparin
- •Intolerance to dexamethasone
- •Contraindication to MRI or unwillingness to undergo all scheduled MRI exams
- •Known or suspected brain metastasis
- •Significant cardiovascular disease such as current New York Heart Associate Class III/IV heart failure, myocardial infarction or stroke within 6 months prior to enrollment
- •A second primary malignancy that, in the judgment of the investigator, may affect the interpretation of results
- •Any illness or condition that in the opinion of the investigator may affect the safety of the subject or the evaluation of any study endpoint
- •Active bacterial or fungal infection requiring IV therapy at the start of protocol treatment
- •Subjects may not receive concomitant anticancer agents or radiation.
- •Female subjects who are pregnant or nursing
- •Pre-existing peripheral neuropathy > CTCAE Grade
- •Known allergy to hyaluronidase
- •Current use of megestrol acetate (use within 10 days of Day 1)
- •Inability to comply with study and follow-up procedures as judged by the Investigator
研究组 & 干预措施
Pegvorhyaluronidase alfa plus Abraxane and Gemcitabine
Pegvorhyaluronidase alfa 3ug/kg IV twice weekly during Cycle 1 and then weekly on days of chemotherapy during Cycles 2-4. Abraxane 125mg/m2 IV and Gemcitabine 1000mg/m2 IV on Day 1, 8, 15 of Cycles 1-4. All cycles will be 28 days.
干预措施: Pegvorhyaluronidase alfa (Drug)
Pegvorhyaluronidase alfa plus Abraxane and Gemcitabine
Pegvorhyaluronidase alfa 3ug/kg IV twice weekly during Cycle 1 and then weekly on days of chemotherapy during Cycles 2-4. Abraxane 125mg/m2 IV and Gemcitabine 1000mg/m2 IV on Day 1, 8, 15 of Cycles 1-4. All cycles will be 28 days.
干预措施: Abraxane (Drug)
Pegvorhyaluronidase alfa plus Abraxane and Gemcitabine
Pegvorhyaluronidase alfa 3ug/kg IV twice weekly during Cycle 1 and then weekly on days of chemotherapy during Cycles 2-4. Abraxane 125mg/m2 IV and Gemcitabine 1000mg/m2 IV on Day 1, 8, 15 of Cycles 1-4. All cycles will be 28 days.
干预措施: Gemcitabine (Drug)
结局指标
主要结局
Change in lesion size
时间窗: baseline and 4 months
Change in lesion size
次要结局
- Proportion of patients achieving a complete R0 surgical resection(at time of surgery)