Clinical trial NCT02896907: Ascorbic Acid and Combination Chemotherapy in Treating Patients With Locally Advanced or Recurrent Pancreatic Cancer That Cannot Be Removed by Surgery
Official title: A Pilot Study of Intravenous Ascorbic Acid and Folfirinox in the Treatment of Advanced Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Pancreatic Adenocarcinoma
Recurrent Pancreatic Carcinoma
Stage III Pancreatic Cancer
Stage IV Pancreatic Cancer
Unresectable Pancreatic Carcinoma
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
First posted: 2016-09-12
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.)

Primary outcomes:
measure: Number of Participants With Adverse Events as Determined by CTCAE Version 4.03
timeFrame: Up to 28 days after the last treatment
Secondary outcomes:
measure: Change in Quality of Life as Defined by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C-30
timeFrame: Baseline to up to 28 days after the last treatment
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Sidney Kimmel Cancer Center at Thomas Jefferson University
state: Pennsylvania
Study officials:
affiliation: Sidney Kimmel Cancer Center at Thomas Jefferson University
name: James Posey, MD
role: PRINCIPAL_INVESTIGATOR
References: