Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:00 PM
Ignite Modification Date:
2025-12-24 @ 1:00 PM
NCT ID:
NCT01654861
Eligibility Criteria:
Inclusion Criteria:
* Patient ≥ 18 years of age
* Biopsy proven adenocarcinoma of the pancreas
* Evidence of metastatic disease
* Received at least 1 prior chemotherapy treatment regimen with disease progression
* May have had any prior chemotherapy regimen including any gemcitabine based regimen or FOLFIRINOX
* May have participated in a prior study protocol
* May have had prior treatment with HDIVC
* Anticipated survival of at least 3 months
* Eastern Cooperative Oncology Group (ECOG) performance status = 0,1, or 2
* The patient must have screening laboratory: ANC ≥ 1,500/mm3, Hemoglobin \> 8g/dL, Platelets ≥ 100,000/mm3, Total Bilirubin \< 1.5mg/dL, Creatinine ≤ 1.5mg/dL, Transaminases \< 2.5 x upper limit of normal, Urine Uric Acid \< 1.000 mg/d, Urine pH \< 6, Urine microscopic negative for oxalates (if positive, reflex urinary oxalates \< 60mg/d), PT INR ≤ 1.5, unless patient is on full dose warfarin
* Glucose-6-phosphate dehydrogenase deficiency (G6PD) normal status via blood test The fluorescent spot test is the simplest, most reliable, and most sensitive of the G6PD screening tests
* Willingness to undergo central line placement and able to manage care of the entry site safely
* Willingness to adhere to supplemental oral dose regimen of ascorbic acid 500mg taken twice daily
* All other nutritional supplements would be discontinued for the duration of the trial except for pancreatic enzymes and probiotics
* Patients must be able to take food orally or have a peg tube for feeding
* Able to give consent for protocol participation
Exclusion Criteria:
* Glucose-6-phosphate dehydrogenase deficiency (G6PD)
* Renal insufficiency : serum creatinine of \> 1.5 mg /dl or evidence of oxalosis by urinalysis prior to enrollment and prior to each HDIVC infusion
* Documentation or report of history of kidney stones or urinary oxalosis.
* Co-morbid condition that would affect survival: congestive heart failure, unstable angina, myocardial infarction within 6 weeks of study, uncontrolled blood sugars of \> 300 mg / dl, patients with known chronic active hepatitis or cirrhosis
* Currently active second malignancy
* Chronic hemodialysis
* Iron overload/ Hemochromatosis: Ferritin \> 500 ng / ml
* Wilson's disease
* Pregnant or lactating female (pre- menopausal females will undergo pregnancy test prior to administration of protocol drugs throughout treatment cycles during this study)
* Aspirin use exceeding 81 mg per day
* Acetaminophen use exceeding 2 g per day
* Known brain metastasis
* Active tobacco smokers
* Treatment with the combination of HDIVC and gemcitabine previously
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01654861
Study Brief:
Protocol Section:
NCT01654861