MRI Effects of Pegvorhyaluronidase Alfa (PEGPH20) in Pancreatic Ductal Adenocarcinoma
Phase 2
Withdrawn
- Conditions
- Pancreatic Ductal Adenocarcinoma
- Interventions
- Registration Number
- NCT04134468
- Lead Sponsor
- Abramson Cancer Center at Penn Medicine
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Pegvorhyaluronidase alfa plus Abraxane and Gemcitabine Pegvorhyaluronidase alfa 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. Pegvorhyaluronidase alfa plus Abraxane and Gemcitabine Abraxane 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. Pegvorhyaluronidase alfa plus Abraxane and Gemcitabine 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.
- Primary Outcome Measures
Name Time Method Change in lesion size baseline and 4 months Change in lesion size
- Secondary Outcome Measures
Name Time Method Proportion of patients achieving a complete R0 surgical resection at time of surgery Proportion of patients achieving a complete R0 surgical resection
Trial Locations
- Locations (1)
Abramson Cancer Center at University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Abramson Cancer Center at University of Pennsylvania🇺🇸Philadelphia, Pennsylvania, United States