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

NCT02896907 | Completed Early Phase 1 Results DMC FDA Drug

• 2 other identifiers: 16D.347JT 8223
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Unresectable Pancreatic Carcinoma; Pancreatic Adenocarcinoma; Recurrent Pancreatic Carcinoma; Stage III Pancreatic Cancer; Stage IV Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

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

  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.

  Up to 28 days after the last treatment

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

  Baseline to up to 28 days after the last treatment

Study Arms (1)

Treatment (FOLFIRINOX, ascorbic acid)

EXPERIMENTAL

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.

Drug: Oxaliplatin; Drug: Irinotecan Hydrochloride; Drug: Leucovorin Calcium; Drug: Fluorouracil; Dietary Supplement: Ascorbic Acid

Interventions

Oxaliplatin DRUG

Given IV

Also known as: 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

Treatment (FOLFIRINOX, ascorbic acid)

Irinotecan Hydrochloride DRUG

Given IV

Also known as: 136572-09-3, Campto, Camptosar, Camptothecin 11

Treatment (FOLFIRINOX, ascorbic acid)

Leucovorin Calcium DRUG

Given IV

Also known as: 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

Treatment (FOLFIRINOX, ascorbic acid)

Fluorouracil DRUG

Given IV

Also known as: 19893, 2,4-Dioxo-5-fluoropyrimidine, 5-Fluoro-2,4(1H, 3H)-pyrimidinedione, 5-Fluorouracil, AccuSite, Fluracedyl, Fluracil, Fluroblastin, Ribofluor, Ro 2-9757

Treatment (FOLFIRINOX, ascorbic acid)

Ascorbic Acid DIETARY_SUPPLEMENT

Given IV

Also known as: 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

Treatment (FOLFIRINOX, ascorbic acid)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Sidney Kimmel Cancer Center at Thomas Jefferson University: lead

Study Sites (1)

Sidney Kimmel Cancer Center at Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Related Links

• Thomas Jefferson University Hospital

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Oxaliplatin; Irinotecan; Leucovorin; Fluorouracil; dehydroftorafur; Ascorbic Acid

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Camptothecin; Alkaloids; Heterocyclic Compounds; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Hydroxy Acids; Carbohydrates

Results Point of Contact

• Title: Dr. James Posey
• Organization: Sidney Kimmel Cancer Center at Thomas Jefferson University

James.Posey@jefferson.edu

215-503-6442

Study Officials

• James Posey, MD

  Sidney Kimmel Cancer Center at Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2016
• First Posted: September 12, 2016
• Study Start: October 18, 2016
• Primary Completion: March 22, 2018
• Study Completion: March 1, 2019
• Last Updated: April 30, 2025
• Results First Posted: January 18, 2020

Record last verified: 2025-04

Locations

US (1)