Description:
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.
Title
- Brief Title: MRI Effects of Pegvorhyaluronidase Alfa (PEGPH20) in Pancreatic Ductal Adenocarcinoma
- Official Title: 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
Clinical Trial IDs
- ORG STUDY ID:
UPCC10219
- SECONDARY ID:
IRB833642
- NCT ID:
NCT04134468
Conditions
- Pancreatic Ductal Adenocarcinoma
Interventions
Drug | Synonyms | Arms |
---|
Pegvorhyaluronidase alfa | PEGPH20 | Pegvorhyaluronidase alfa plus Abraxane and Gemcitabine |
Abraxane | | Pegvorhyaluronidase alfa plus Abraxane and Gemcitabine |
Gemcitabine | | Pegvorhyaluronidase alfa plus Abraxane and Gemcitabine |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
Pegvorhyaluronidase alfa plus Abraxane and Gemcitabine | Experimental | 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
- Abraxane
- Gemcitabine
|
Eligibility Criteria
Inclusion Criteria:
1. Signed Informed Consent Form
2. Capable of giving informed consent.
3. Ability and willingness to comply with the protocol including all scheduled MRI
studies and paired tumor biopsies
4. Aged ≥ 18 years.
5. borderline or unresectable pancreatic adenocarcinoma without distant metastatic
disease.
6. ECOG PS of 0 or 1
7. Must have adequate organ and hematopoietic function
8. Female and Males must use an approved contraceptive method
Exclusion Criteria:
1. Received prior therapy for pancreatic adenocarcinoma
2. History of deep vein thrombosis (DVT) or pulmonary embolism (PE)
3. Contraindication to therapeutic anticoagulation or heparin
4. Intolerance to dexamethasone
5. Contraindication to MRI or unwillingness to undergo all scheduled MRI exams
6. Known or suspected brain metastasis
7. 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
8. A second primary malignancy that, in the judgment of the investigator, may affect the
interpretation of results
9. 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
10. Active bacterial or fungal infection requiring IV therapy at the start of protocol
treatment
11. Subjects may not receive concomitant anticancer agents or radiation.
12. Female subjects who are pregnant or nursing
13. Pre-existing peripheral neuropathy > CTCAE Grade 2.
14. Known allergy to hyaluronidase
15. Current use of megestrol acetate (use within 10 days of Day 1)
16. Inability to comply with study and follow-up procedures as judged by the Investigator
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Change in lesion size |
Time Frame: | baseline and 4 months |
Safety Issue: | |
Description: | Change in lesion size |
Secondary Outcome Measures
Measure: | Proportion of patients achieving a complete R0 surgical resection |
Time Frame: | at time of surgery |
Safety Issue: | |
Description: | Proportion of patients achieving a complete R0 surgical resection |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Withdrawn |
Lead Sponsor: | Abramson Cancer Center of the University of Pennsylvania |
Last Updated
January 31, 2020