RecruitingEarly Phase 1NCT05365893

PHL Treatment in Pancreatic Cancer

Window of Opportunity for Neoadjuvant Stroma Modification in Pancreatic Cancer


Sponsor

Fox Chase Cancer Center

Enrollment

20 participants

Start Date

Oct 20, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

This proposal will investigate the effect of paricalcitol, hydroxychloroquine, and losartan (PHL) combination of 3 stroma-modifying drugs on pancreatic adenocarcinoma and its stroma.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing an experimental drug combination called PHL (which includes hydroxychloroquine and other medications) alongside standard chemotherapy and radiation for people with pancreatic cancer that can be surgically removed. Researchers want to know if adding PHL before surgery improves outcomes. **You may be eligible if...** - You have newly diagnosed pancreatic cancer confirmed by biopsy - Your cancer has not spread (non-metastatic) and is planned for surgery - You are planned to receive at least 3 months of chemotherapy (FOLFIRINOX) followed by chemoradiation and then surgery - You are 18 or older and in reasonably good health - Your organ function (liver, kidneys) is within normal range **You may NOT be eligible if...** - Your cancer has spread to other parts of the body - You are currently taking hydroxychloroquine or blood pressure medications called ARBs - You are pregnant or breastfeeding - You have a history of retinal disease, low blood pressure, or high calcium levels - You have serious kidney disease (creatinine clearance below 30 mL/min) - You have significant heart rhythm problems (QT prolongation or AV block) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

COMBINATION_PRODUCTParicalcitol, Hydroxychloroquine, Losartan

Paricalcitol 25 mcg IV administered M-W-F Hydroxychloroquine 600 mg PO BID Losartan 50 mg PO daily

OTHERNeoadjuvant therapy and surgery only (Control)

Control arm These patients will proceed to surgery at completion of neoadjuvant therapy.


Locations(1)

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

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NCT05365893


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