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PHL Combination for Pancreatic Cancer

Phase < 1
Recruiting
Led By Efrat Dotan, MD
Research Sponsored by Fox Chase Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age > 18 years
Patients must have new diagnosed histologically or cytologically confirmed pancreatic adenocarcinoma
Must not have
Tumors of acinar or adenocarcinoma histology
Patients with radiological or cytologically confirmed metastatic or unresectable disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial will study the effects of a combination of three drugs on pancreatic cancer and the surrounding tissues.

Who is the study for?
This trial is for adults over 18 with newly diagnosed, resectable pancreatic adenocarcinoma. They must have completed or plan to complete a specific chemotherapy regimen and surgery. Participants need normal organ function, not be pregnant or breastfeeding, and agree to use effective birth control. Those with certain heart conditions, severe eye diseases, uncontrolled illnesses, or taking conflicting medications cannot join.
What is being tested?
The study tests the combination of three drugs (Paricalcitol, Hydroxychloroquine, Losartan) on pancreatic cancer compared to standard neoadjuvant therapy followed by surgery alone. The goal is to see if these drugs can modify the tumor environment and improve outcomes.
What are the potential side effects?
Potential side effects include risk of heart issues like QT prolongation leading to arrhythmias; vision problems such as retinopathy; low blood pressure; allergic reactions similar to those from related compounds; and possible interactions with other medications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am older than 18 years.
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I have been newly diagnosed with pancreatic cancer.
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I am fully active or can carry out light work.
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I am scheduled for a specific cancer treatment plan including surgery.
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My liver and kidney functions are within normal ranges.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My cancer is of a specific type, either acinar or adenocarcinoma.
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My cancer has spread and cannot be removed with surgery.
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I am currently taking hydroxychloroquine or an angiotensin II receptor blocker.
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I don't have severe eye problems, very low blood pressure, or a history of high calcium needing treatment.
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I do not have any serious illnesses or social situations that would stop me from following the study's requirements.
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I am not taking any medications that interfere with PHL.
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I have severe side effects from previous cancer treatments.
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I don't have a history of severe allergic reactions, low blood pressure, or severe kidney disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of participants who experience grade 3 or greater treatment-related adverse events assessed by CTCAE v5.0

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: PHL (Paricalcitol, Hydroxychloroquine, Losartan)Experimental Treatment1 Intervention
Paricalcitol 25 mcg IV administered M-W-F Hydroxychloroquine 600 mg PO BID Losartan 50 mg PO daily
Group II: Neoadjuvant therapy and surgery only (Control)Active Control1 Intervention
Control arm These patients will proceed to surgery at completion of neoadjuvant therapy.

Find a Location

Who is running the clinical trial?

Fox Chase Cancer CenterLead Sponsor
234 Previous Clinical Trials
39,353 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,945 Previous Clinical Trials
41,024,704 Total Patients Enrolled
Efrat Dotan, MDPrincipal InvestigatorFox Chase Cancer Center
1 Previous Clinical Trials
4 Total Patients Enrolled

Media Library

Paricalcitol, Hydroxychloroquine, Losartan (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05365893 — Phase < 1
Pancreatic Cancer Research Study Groups: PHL (Paricalcitol, Hydroxychloroquine, Losartan), Neoadjuvant therapy and surgery only (Control)
Pancreatic Cancer Clinical Trial 2023: Paricalcitol, Hydroxychloroquine, Losartan Highlights & Side Effects. Trial Name: NCT05365893 — Phase < 1
Paricalcitol, Hydroxychloroquine, Losartan (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05365893 — Phase < 1
~1 spots leftby Mar 2025
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