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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02896907
Other study ID # 16D.347
Secondary ID
Status Completed
Phase Early Phase 1
First received
Last updated
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
Health authority
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.)

Study Design


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
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