MRI Effects of Pegvorhyaluronidase Alfa (PEGPH20) in Pancreatic Ductal Adenocarcinoma

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Pancreatic Ductal Adenocarcinoma

Intervention / Treatment
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* Drug: Pegvorhyaluronidase alfa
* Drug: Abraxane
* Drug: Gemcitabine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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 2. 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pegvorhyaluronidase alfa plus Abraxane and Gemcitabine<br>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. | Drug: Pegvorhyaluronidase alfa<br>* IV infusion<br>* Other names: PEGPH20;Drug: Abraxane<br>* IV infusion<br>Drug: Gemcitabine<br>* IV infusion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in lesion size | Change in lesion size | baseline and 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients achieving a complete R0 surgical resection | Proportion of patients achieving a complete R0 surgical resection | at time of surgery |