Early Phase 1
Completed N=8
Ascorbic Acid and Combination Chemotherapy in Treating Patients With Locally Advanced or Recurrent Pancreatic Cancer That Cannot Be Removed by Surgery
Pancreatic Adenocarcinoma · Recurrent Pancreatic Carcinoma · Stage III Pancreatic Cancer · Stage IV Pancreatic Cancer
Source: ClinicalTrials.gov NCT02896907 ↗
Enrolled (actual)
8
Serious AEs
75.0%
Results posted
Jan 2020
Primary outcomePrimary: Number of Participants With Adverse Events as Determined by CTCAE Version 4.03 — 1; 1; 4; 2 Participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events as Determined by CTCAE Version 4.03 |
1; 1; 4; 2 | — |
| SECONDARY Change in Quality of Life as Defined by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C-30 |
NA | — |
Eligibility Criteria
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.)
Data sourced from ClinicalTrials.gov (NCT02896907). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.