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New treatment option for Adenocarcinoma of the Pancreas
Official title Neoadjuvant mFOLFIRINOX With Perioperative Oral Hydroxychloroquine in Resectable Pancreatic Adenocarcinoma
ClinicalTrials.gov ID: NCT04911816
What this study is testing
What is Hydroxychloroquine sulfate?
Hydroxychloroquine sulfate is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for adenocarcinoma of the pancreas.
Also referred to as Plaquenil.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This will be a phase I/II trial examining the safety and tolerability of pre-operative mFOLFIRINOX in combination with peri-operative oral hydroxychloroquine (FHQ) in the treatment of subjects with adenocarcinoma of the pancreas. Subjects will be staged prior to protocol entry by contrast-enhanced helical abdominal CT scan done using a pancreas mass protocol or EUS.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- people with biopsy-proven adenocarcinoma of the pancreas
- Pancreatic protocol helical CT scan demonstrating absence of venous or arterial involvement, consistent with NCCN guidelines for resectable disease
- ECOG performance status ≤ 1
- No active second malignancy except for basal cell carcinoma of the skin
- Normal renal, hepatic, and hematologic function at the time of enrollment as evidenced by:
You likely can't join if
- people deemed surgically unresectable or people unwilling to undergo surgical resection.
- people who have received chemotherapy within 12 months prior to study entry.
- people who are found to have loss-of-function mutations in DPYD or UGTA1 by Oneome pharmacogenomic testing, resulting in increased risk of...
- Prior use of radiotherapy or investigational agents for pancreatic cancer.
- Any evidence of metastasis to distant organs (liver, lung, peritoneum).
- Cross sectional imaging suggesting portal vein, superior mesenteric artery, hepatic artery involvement that would make the patient borderline...
See the full eligibility criteria
- people with biopsy-proven adenocarcinoma of the pancreas
- Pancreatic protocol helical CT scan demonstrating absence of venous or arterial involvement, consistent with NCCN guidelines for resectable disease
- ECOG performance status ≤ 1
- No active second malignancy except for basal cell carcinoma of the skin
- Normal renal, hepatic, and hematologic function at the time of enrollment as evidenced by:
- Serum creatinine level ≤1.5 the upper limits of normal
- Serum total bilirubin level ≤1.5 X ULN
- White blood cell count ≥ 3.5x109/ml per ml and platelet count ≥ 100x109 per ml
- For people with obstructive jaundice, the biliary tract must be drained with a temporary plastic or a short permanent metallic biliary stent
- Ability to understand and the willingness to sign a written informed consent document.
- people deemed surgically unresectable or people unwilling to undergo surgical resection.
- people who have received chemotherapy within 12 months prior to study entry.
- people who are found to have loss-of-function mutations in DPYD or UGTA1 by Oneome pharmacogenomic testing, resulting in increased risk of mFOLFIRINOX toxicity. DPYD mutations have been noted in 5% of the overall...
- Prior use of radiotherapy or investigational agents for pancreatic cancer.
- Any evidence of metastasis to distant organs (liver, lung, peritoneum).
- Cross sectional imaging suggesting portal vein, superior mesenteric artery, hepatic artery involvement that would make the patient borderline resectable or locally advanced
- Symptomatic or endoscopic evidence of gastric outlet obstruction.
- Concurrent malignancies with evidence of active or measurable disease except basal cell carcinoma of the skin.
- Inability to adhere to study and/or follow-up procedures.
- History of allergic reactions or hypersensitivity to the study drugs (chloroquine, hydroxychloroquine, 5-Fluorouracil, Leucovorin, Oxaliplatin, Irinotecan).
- Other concurrent experimental therapy.
- The effects of HCQ, and mFOLFIRINOX on the developing human fetus are unknown. For this reason women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth...
- Because patients with immune deficiency are at increased risk of lethal infections when treated with bone marrow-suppressive therapy, HIV-positive patients are excluded from the study. For patients receiving combination...
- Due to the risk of disease exacerbation, patients with porphyria are ineligible.
- Patients with psoriasis are ineligible unless the disease is well controlled and they are under the care of a specialist who agrees to monitor the patient for exacerbations.
- Patients requiring the use of enzyme-inducing anti-epileptic medication that includes: phenytoin, carbamazepine, phenobarbital, primidone or oxcarbazepine are excluded.
- Patients with previously documented macular degeneration or diabetic retinopathy are excluded.
- Baseline EKG with QTc \>470 msec (including people on medication). people with ventricular pacemaker for whom QT interval is not measurable will be eligible on a case-by-case basis.
The study team makes the final eligibility decision.
Where it's taking place
- Morgantown, West Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Morgantown, West Virginia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.