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A Pilot Study of Intravenous Ascorbic Acid and Folfirinox in the Treatment of Advanced Pancreatic Cancer (NCT02896907)

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.
  • Drug: Oxaliplatin
    Given IV
    • Diaminocyclohexane Oxalatoplatinum
    • Eloxatin
    • Dacotin
    • Dacplat
    • 61825-94-3
    • [(1R,-2R)-1,2-cyclohexanediamine-N,N'][oxalato (2--)-O,O']platinum
    • [Sp-4-2-(1R-trans)]-(1,2,cyclohexanediamine-N,N')[ethanedioato(2--)-O,O']platinum
    • Ai Heng
    • Oxalatoplatin
    • trans-l diaminocyclohexane oxalatoplatinum
  • Drug: Irinotecan Hydrochloride
    Given IV
    • 136572-09-3
    • Campto
    • Camptosar
    • Camptothecin 11
  • Drug: Leucovorin Calcium
    Given IV
    • 1492-18-8
    • 3590
    • 5-Formyl Tetrahydrofolate
    • 5-Formyl-5,6,7,8-tetrahydrofolic Acid
    • 5-Formyl-5,6,7,8-tetrahydropteroyl-L-glutamic Acid
    • Adinepar
    • Calcifolin
    • Calcium (6S)-Folinate
    • Calcium Folinate
    • Calcium N-(p-((((6RS)-2-amino-5-formyl-5,6,7,8-tetrahydro-4-hydroxy-6-pteridinyl)methyl)amino)benzoyl)-L-glutamate (1:1)
    • Calfolex
    • Calinat
    • Cehafolin
    • Citofolin
    • Citrec
    • Citrovorum Factor
    • Cromatonbic Folinico
    • Dalisol
    • Disintox
    • Divical
    • Ecofol
    • Emovis
    • Flynoken A
    • Folaren
    • Folaxin
    • Foliben
    • Folinic Acid Calcium Salt Pentahydrate
    • Folix
    • Lederfolin
    • Leucosar
    • N-[4-[[(2-Amino-5-formyl-1,4,5,6,7,8-hexahydro-4-oxo-6-pteridinyl)methyl]amnio]benzoyl]-L-glutamic Acid
    • Rescufolin
    • Tonofolin
    • Rescuvolin
    • Wellcovorin
  • Drug: Fluorouracil
    Given IV
    • 19893
    • 2,4-Dioxo-5-fluoropyrimidine
    • 5-Fluoro-2,4(1H, 3H)-pyrimidinedione
    • 5-Fluorouracil
    • AccuSite
    • Fluracedyl
    • Fluracil
    • Fluroblastin
    • Ribofluor
    • Ro 2-9757
  • : Ascorbic Acid
    Given IV
    • 2-(1,2-dihydroxyethyl)-4,5-dihydroxy-furan-3-one
    • 33832
    • 50-81-7
    • Asorbicap
    • C Vitamin
    • C-Long
    • Ce-Vi-Sol
    • Cecon
    • Cenolate
    • L-Ascorbic Acid
    • Vitamin C
Ages eligible for Study
18 Years to 75 Years
Genders eligible for Study
All
Accepts Healthy Volunteers
No
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.)
PRIMARY OBJECTIVES:

I. To determine safety of intravenous ascorbic acid in combination with fluorouracil, irinotecan hydrochloride, leucovorin calcium, and oxaliplatin (FOLFIRINOX) as defined by Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 in patients with advanced pancreatic cancer.

SECONDARY OBJECTIVES:

I. To test feasibility of collecting quality of life (QOL), patient reported outcomes (PRO) data and correlative studies on patients with advanced pancreatic cancer.

1 locations

United States (1)
  • Sidney Kimmel Cancer Center at Thomas Jefferson University
    recruiting
    Philadelphia, Pennsylvania, United States, 19107
Status:
recruiting
Type:
Interventional
Phase:
0
Start:
20 March, 2017
Updated:
24 October, 2017
Participants:
8
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