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

Pancreatic Adenocarcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02896907
• Other study ID #: 16D.347
• Status: Completed
• Phase: Early Phase 1
• Start date: October 18, 2016
• Est. completion date: March 2019

Study information

• Verified date: January 2020
• Source: Thomas Jefferson University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: March 2019
• Est. primary completion date: March 22, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.)

Related Conditions & MeSH terms

• Adenocarcinoma
• Carcinoma
• Pancreatic Adenocarcinoma
• Pancreatic Neoplasms
• Recurrent Pancreatic Carcinoma
• Stage III Pancreatic Cancer
• Stage IV Pancreatic Cancer
• Unresectable Pancreatic Carcinoma

Intervention

Drug:
• Oxaliplatin
Given IV
• Irinotecan Hydrochloride
Given IV
• Leucovorin Calcium
Given IV
• Fluorouracil
Given IV

Dietary Supplement:
• Ascorbic Acid
Given IV

Locations

Country	Name	City	State
United States	Sidney Kimmel Cancer Center at Thomas Jefferson University	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Sidney Kimmel Cancer Center at Thomas Jefferson University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in Quality of Life as Defined by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C-30	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.	Baseline to up to 28 days after the last treatment

External Links

•   Sidney Kimmel Cancer Center at Thomas Jefferson University, an NCI-Designated Cancer Center
•   Thomas Jefferson University Hospital