Clinical trial · Interventional
Ascorbic Acid and Combination Chemotherapy in Treating Patients With Locally Advanced or Recurrent Pancreatic Cancer That Cannot Be Removed by Surgery
A Pilot Study of Intravenous Ascorbic Acid and Folfirinox in the Treatment of Advanced Pancreatic Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This pilot clinical trial studies the side effects of ascorbic acid and combination chemotherapy in treating patients with pancreatic cancer that has spread to other places in the body, has come back, or cannot be removed by surgery. Nutrients found in food and dietary supplements, such as ascorbic acid, may improve the tolerability of chemotherapy regimens. Drugs used in chemotherapy, such as fluorouracil, irinotecan hydrochloride, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving ascorbic acid and combination chemotherapy may work better in treating patients with pancreatic cancer.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Adenocarcinoma | Pancreatic Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Recurrent Pancreatic Carcinoma | Pancreatic Carcinoma | CURATED_BROADER | 0.78 |
| Stage III Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_BROADER | 0.78 |
| Stage IV Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_BROADER | 0.78 |
| Unresectable Pancreatic Carcinoma | Pancreatic Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ascorbic Acid | Dietary Supplement | — | UNRESOLVED |
| Fluorouracil | Drug | Fluorouracil | ALIAS |
| Irinotecan Hydrochloride | Drug | Irinotecan | ALIAS |
| Leucovorin Calcium | Drug | Leucovorin | ALIAS |
| Oxaliplatin | Drug | Oxaliplatin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (FOLFIRINOX, ascorbic acid)
- description
- Patients receive oxaliplatin IV over 2 hours, irinotecan hydrochloride IV over 90 minutes, leucovorin calcium IV over 2 hours, and fluorouracil IV continuously over 46 hours on day 1. Patients then receive ascorbic acid IV over 2 hours on days 3, 5, 8, 10 and 12. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: Oxaliplatin
- Drug: Irinotecan Hydrochloride
- Drug: Leucovorin Calcium
- Drug: Fluorouracil
- Dietary Supplement: Ascorbic Acid
Primary outcomes (1)
- measure
- Number of Participants With Adverse Events as Determined by CTCAE Version 4.03
- timeFrame
- Up to 28 days after the last treatment
- description
- After 4 patients are enrolled on the study and receive at least one dose of intravenous ascorbic acid, the data will be reviewed. If 2 out of the 4 cannot complete 2 courses of FOLFIRINOX then the study will be halted.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Capable of giving informed consent * Histological diagnosis of adenocarcinoma of the pancreas * Stage IV or recurrent pancreatic cancer by imaging * Locally advanced unresectable pancreatic cancer by National Comprehensive Cancer Network (NCCN) criteria * Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1 * No prior treatment for metastatic disease (prior neo-adjuvant or adjuvant chemotherapy, except FOLFIRINOX, chemoradiation or radiation allowed) * White blood count \>= 3000 * Platelets \>= 100,000 * Total bilirubin =\< 1.5 mg/dl * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 5 X upper limit of normal (ULN) * Creatinine \< 1.5 mg/dL * Glucose-6-phosphatase deficiency (G6PD) level of 5-14 units/g hemoglobin (Hgb) or within institutional standard parameters * All subjects of child producing potential must agree to use contraception or avoidance of pregnancy measures while enrolled on study Exclusion Criteria: * Other pancreatic cancer histology (islet cell, acinar, neuroendocrine tumors) * Resectable pancreatic cancer * Prior neoadjuvant FOLFIRINOX * Pregnant or lactating females * No clinical ascites (mild ascites on scans permissible) * Central nervous system (CNS) metastasis * Known congestive heart failure, significant ventricular arrhythmias, cirrhosis, grade 4/5 chronic kidney disease, uncontrolled diabetes * Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy * Peripheral neuropathy grade 2 or greater * Any condition, psychiatric or otherwise, that would preclude informed consent, consistent follow-up or compliance with any aspect of the study (e.g., untreated schizophrenia or other significant cognitive impairment, etc.)
References
Publications (0)
Data not yet available