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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of participants who experience grade 3 or greater treatment-related adverse events assessed by CTCAE v5.0
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
229 Previous Clinical Trials
38,156 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,718 Previous Clinical Trials
40,963,324 Total Patients Enrolled
Efrat Dotan, MDPrincipal InvestigatorFox Chase Cancer Center
1 Previous Clinical Trials
4 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am older than 18 years.My cancer is of a specific type, either acinar or adenocarcinoma.I am currently taking an ACE inhibitor, ARB, vitamin D, or hydroxychloroquine but can stop vitamin D to join the study.My cancer has spread and cannot be removed with surgery.I have been newly diagnosed with pancreatic cancer.I am currently taking hydroxychloroquine or an angiotensin II receptor blocker.I am not pregnant, using effective birth control, and if applicable, have been postmenopausal for at least 12 months.I don't have severe eye problems, very low blood pressure, or a history of high calcium needing treatment.I do not have any serious illnesses or social situations that would stop me from following the study's requirements.I am fully active or can carry out light work.I have risk factors for a serious heart rhythm problem (like heart failure or family history of Long QT Syndrome).I am not taking any medications that interfere with PHL.I have severe side effects from previous cancer treatments.I am scheduled for a specific cancer treatment plan including surgery.My liver and kidney functions are within normal ranges.I don't have a history of severe allergic reactions, low blood pressure, or severe kidney disease.My pancreatic cancer can be surgically removed and I will have surgery 4-12 weeks after my initial treatment.
Research Study Groups:
This trial has the following groups:- Group 1: PHL (Paricalcitol, Hydroxychloroquine, Losartan)
- Group 2: Neoadjuvant therapy and surgery only (Control)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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