Actively Recruiting
PHL Treatment in Pancreatic Cancer
Led by Fox Chase Cancer Center · Updated on 2025-04-16
20
Participants Needed
1
Research Sites
271 weeks
Total Duration
On this page
Sponsors
F
Fox Chase Cancer Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This proposal will investigate the effect of paricalcitol, hydroxychloroquine, and losartan (PHL) combination of 3 stroma-modifying drugs on pancreatic adenocarcinoma and its stroma.
CONDITIONS
Official Title
PHL Treatment in Pancreatic Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must have newly diagnosed histologically or cytologically confirmed pancreatic adenocarcinoma.
- Patients must have resectable non-metastatic PDAC and plan surgery 4 to 12 weeks after completing neoadjuvant chemotherapy and radiation.
- Patients must be planned for at least 3 months of modified FOLFIRINOX treatment followed by chemoradiation and surgery.
- Age over 18 years.
- ECOG performance status of 0 or 1.
- Normal organ function: total bilirubin within normal limits; AST/ALT less than 5 times normal limits; creatinine within normal limits or creatinine clearance over 30 mL/min/1.73 m2.
- Women of childbearing potential must have a negative pregnancy test within 72 hours before registration.
- Postmenopausal women must have been amenorrheic and nonlactating for at least 12 months.
- Men and women of childbearing potential must agree to use effective birth control during the study and for 3 months after.
- Ability to understand and sign informed consent and HIPAA consent.
- For Arm A: Patients completed at least 3 months of modified FOLFIRINOX followed by chemoradiation and plan surgery 4 to 12 weeks later.
- For Arm A: Ability to understand and sign informed consent and HIPAA consent.
You will not qualify if you...
- Tumors with acinar or adenocarcinoma histology other than PDAC.
- Receiving any other investigational agents.
- Currently taking hydroxychloroquine or angiotensin II receptor blockers.
- Radiological or cytological evidence of metastatic or unresectable disease.
- Pregnant or breastfeeding.
- For Arm A: Residual grade 3 or higher side effects from prior chemotherapy or chemoradiotherapy.
- For Arm A: Use of ACE inhibitors, ARBs, vitamin D supplements (unless stopped), or hydroxychloroquine.
- For Arm A: History of retinopathy, macular degeneration, severe eye problems, baseline low blood pressure (systolic <100 mmHg), or hypercalcemia needing treatment.
- For Arm A: Known disorders preventing use of study drugs, including angioedema, hypotension, or severe kidney disease (creatinine clearance <30 mL/min).
- For Arm A: Allergic reactions to similar drugs.
- For Arm A: Use of medications that interact significantly with PHL.
- For Arm A: Marked baseline prolongation of QT/QTc interval or risk factors for Torsades de Pointes.
- For Arm A: Second or third degree atrioventricular block.
- For Arm A: Uncontrolled illnesses including active infections, symptomatic heart failure, unstable angina, arrhythmia, or psychiatric/social issues limiting study compliance.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Actively Recruiting
Research Team
S
Sanjay Reddy, MD, FACS
CONTACT
R
Ryan Romasko
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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