Ascorbic Acid and Combination Chemotherapy in Treating Patients With Locally Advanced or Recurrent Pancreatic Cancer That Cannot Be Removed by Surgery
Primary Purpose
Pancreatic Adenocarcinoma, Recurrent Pancreatic Carcinoma, Stage III Pancreatic Cancer
Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Oxaliplatin
Irinotecan Hydrochloride
Leucovorin Calcium
Fluorouracil
Ascorbic Acid
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatic Adenocarcinoma
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.)
Sites / Locations
- Sidney Kimmel Cancer Center at Thomas Jefferson University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment (FOLFIRINOX, ascorbic acid)
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT02896907
First Posted
September 6, 2016
Last Updated
January 15, 2020
Sponsor
Sidney Kimmel Cancer Center at Thomas Jefferson University
1. Study Identification
Unique Protocol Identification Number
NCT02896907
Brief Title
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
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
October 18, 2016 (Actual)
Primary Completion Date
March 22, 2018 (Actual)
Study Completion Date
March 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sidney Kimmel Cancer Center at Thomas Jefferson University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Adenocarcinoma, Recurrent Pancreatic Carcinoma, Stage III Pancreatic Cancer, Stage IV Pancreatic Cancer, Unresectable Pancreatic Carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment (FOLFIRINOX, ascorbic acid)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin
Other Intervention Name(s)
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
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
Irinotecan Hydrochloride
Other Intervention Name(s)
136572-09-3, Campto, Camptosar, Camptothecin 11
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
Leucovorin Calcium
Other Intervention Name(s)
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
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
Fluorouracil
Other Intervention Name(s)
19893, 2,4-Dioxo-5-fluoropyrimidine, 5-Fluoro-2,4(1H, 3H)-pyrimidinedione, 5-Fluorouracil, AccuSite, Fluracedyl, Fluracil, Fluroblastin, Ribofluor, Ro 2-9757
Intervention Description
Given IV
Intervention Type
Dietary Supplement
Intervention Name(s)
Ascorbic Acid
Other Intervention Name(s)
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
Intervention Description
Given IV
Primary Outcome Measure Information:
Title
Number of Participants With Adverse Events as Determined by CTCAE Version 4.03
Description
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.
Time Frame
Up to 28 days after the last treatment
Secondary Outcome Measure Information:
Title
Change in Quality of Life as Defined by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C-30
Description
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.
Time Frame
Baseline to up to 28 days after the last treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Posey, MD
Organizational Affiliation
Sidney Kimmel Cancer Center at Thomas Jefferson University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sidney Kimmel Cancer Center at Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
12. IPD Sharing Statement
Links:
URL
http://hospitals.jefferson.edu/
Description
Thomas Jefferson University Hospital
Learn more about this trial
Ascorbic Acid and Combination Chemotherapy in Treating Patients With Locally Advanced or Recurrent Pancreatic Cancer That Cannot Be Removed by Surgery
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