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

NCT ID: NCT02896907

Last Updated: 2025-04-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-18
• Study Completion Date: 2019-03-31

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.

Detailed Description

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment (FOLFIRINOX, ascorbic acid)

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.

Group Type: EXPERIMENTAL

Oxaliplatin

Intervention Type: DRUG

Given IV

Irinotecan Hydrochloride

Intervention Type: DRUG

Given IV

Leucovorin Calcium

Intervention Type: DRUG

Given IV

Fluorouracil

Intervention Type: DRUG

Given IV

Ascorbic Acid

Intervention Type: DIETARY_SUPPLEMENT

Given IV

Interventions

Oxaliplatin

Given IV

Intervention Type: DRUG

Irinotecan Hydrochloride

Given IV

Intervention Type: DRUG

Leucovorin Calcium

Given IV

Intervention Type: DRUG

Fluorouracil

Given IV

Intervention Type: DRUG

Ascorbic Acid

Given IV

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention 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; 136572-09-3; Campto; Camptosar; Camptothecin 11; 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; 19893; 2,4-Dioxo-5-fluoropyrimidine; 5-Fluoro-2,4(1H, 3H)-pyrimidinedione; 5-Fluorouracil; AccuSite; Fluracedyl; Fluracil; Fluroblastin; Ribofluor; Ro 2-9757; 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

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.)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sidney Kimmel Cancer Center at Thomas Jefferson University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

James Posey, MD

Role: PRINCIPAL_INVESTIGATOR

Sidney Kimmel Cancer Center at Thomas Jefferson University

Locations

Sidney Kimmel Cancer Center at Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

http://hospitals.jefferson.edu/

Thomas Jefferson University Hospital

Other Identifiers

JT 8223

Identifier Type: OTHER

Identifier Source: secondary_id

16D.347

Identifier Type: -

Identifier Source: org_study_id