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NCT Number: NCT02896907

Ascorbic Acid and Combination Chemotherapy in Treating Patients With Locally Advanced or Recurrent Pancreatic Cancer That Cannot Be Removed by Surgery

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.

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Key information

Conditions

Pancreatic Adenocarcinoma Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms Recurrent Pancreatic Carcinoma Stage III Pancreatic Cancer Stage IV Pancreatic Cancer Unresectable Pancreatic Carcinoma

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Sidney Kimmel Cancer Center at Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

Oxaliplatin

Drug

Given IV

Other names: 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

irinotecan hydrochloride

Drug

Given IV

Other names: 136572-09-3, Campto, Camptosar, Camptothecin 11

leucovorin calcium

Drug

Given IV

Other names: 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

Fluorouracil

Drug

Given IV

Other names: 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

Dietary Supplement

Given IV

Other names: 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

Primary outcomes

  1. Number of Participants With Adverse Events as Determined by CTCAE Version 4.03

    Time frame: Up to 28 days after the last treatment

    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.

Secondary outcomes

  1. Change in Quality of Life as Defined by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C-30

    Time frame: Baseline to up to 28 days after the last treatment

    Change in quality of life over the six measurement times will be modeled using mixed effects linear regression to account for correlation among repeated measurements from the same subjects. Average change in QoL from baseline to follow-up will be computed.

Sponsors and collaborators

Lead sponsor

Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2019
First posted
Sep 12, 2016
Registry last updated
Apr 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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