Status:
RECRUITING
Neoadjuvant mFOLFIRINOX With Perioperative Oral Hydroxychloroquine in Resectable Pancreatic Adenocarcinoma
Lead Sponsor:
West Virginia University
Conditions:
Adenocarcinoma of the Pancreas
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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 ad...
Detailed Description
A subject is deemed evaluable if they have received at least 3 of 4 cycles of chemotherapy and at least 80% of the expected HCQ doses and undergo successful surgical extirpation their disease. Patient...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Subjects 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 subjects 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.
- Exclusion Criteria
- Subjects deemed surgically unresectable or subjects unwilling to undergo surgical resection.
- Subjects who have received chemotherapy within 12 months prior to study entry.
- Subjects 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 population. Homozygous UGT1A1 mutations have been noted in 10% of North Americans.
- 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 control; abstinence) prior to study entry and for the duration of study participation. All females of childbearing potential must have a blood test or urine study within two weeks prior to registration to rule out pregnancy. Should a woman become pregnant while participating in this study, she should inform her treating physician immediately. If a man impregnates a woman while participating in this study, he should inform his treating physician immediately as well.
- 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 anti-retroviral therapy, the potential impact of pharmacokinetic interactions with HCQ and mFOLFIRINOX is unknown. Appropriate studies may be undertaken in patients with HIV and those receiving combination anti-retroviral therapy in the future.
- 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 subjects on medication). Subjects with ventricular pacemaker for whom QT interval is not measurable will be eligible on a case-by-case basis.
Exclusion
Key Trial Info
Start Date :
July 16 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2030
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04911816
Start Date
July 16 2021
End Date
June 1 2030
Last Update
February 24 2025
Active Locations (1)
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1
West Virginia University Cancer Institute Mary Babb Randolph Cancer Center
Morgantown, West Virginia, United States, 26506