Pancreatic AdenocarcinomaEarly Phase 1NCT02896907

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

A Early Phase 1 study testing Oxaliplatin, Irinotecan Hydrochloride and Leucovorin Calcium in people with Pancreatic Adenocarcinoma and Recurrent Pancreatic Carcinoma, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Pancreatic Adenocarcinoma, Recurrent Pancreatic Carcinoma, Stage III Pancreatic Cancer
What is being tested?: Oxaliplatin, Irinotecan Hydrochloride and Leucovorin Calcium
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 8 participants
Where: 1 siteUnited States
Study dates: 18 Oct 2016to Mar 2019
Phase: Early Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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)

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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

Who cannot join

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

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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.)

Trial locations and contacts

1 site in 1 country.

United States1 site

Sidney Kimmel Cancer Center at Thomas Jefferson University
Philadelphia, Pennsylvania, 19107

Other trials in United States

About this study

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

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.

Read the detailed description

PRIMARY OBJECTIVES:

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:

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
Being tested: Oxaliplatin, Irinotecan Hydrochloride, Leucovorin Calcium, Fluorouracil, Ascorbic Acid
Medical subject headings: Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

OxaliplatinDrug
Also called Diaminocyclohexane Oxalatoplatinum, Eloxatin, Dacotin, Dacplat
Given IV
Irinotecan HydrochlorideDrug
Also called 136572-09-3, Campto, Camptosar, Camptothecin 11
Given IV
Leucovorin CalciumDrug
Also called 1492-18-8, 3590, 5-Formyl Tetrahydrofolate, 5-Formyl-5,6,7,8-tetrahydrofolic Acid
Given IV
FluorouracilDrug
Also called 19893, 2,4-Dioxo-5-fluoropyrimidine, 5-Fluoro-2,4(1H, 3H)-pyrimidinedione, 5-Fluorouracil
Given IV
Ascorbic AcidDietary supplement
Also called 2-(1,2-dihydroxyethyl)-4,5-dihydroxy-furan-3-one, 33832, 50-81-7, Asorbicap
Given IV

Study groups in NCT02896907
Study group	Role	What they receive
Treatment (FOLFIRINOX, ascorbic acid)	Experimental	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. Receives: Drug: Oxaliplatin; Drug: Irinotecan Hydrochloride; Drug: Leucovorin Calcium; Drug: Fluorouracil; Dietary Supplement: Ascorbic Acid

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Up to 28 days after the last treatment

Secondary outcomes (1)

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.
Measured: Baseline to up to 28 days after the last treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Oct 2016Mar 2019

First posted12 Sep 2016 (estimated)
Study start18 Oct 2016
Primary completion22 Mar 2018
Study completionMar 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Pancreatic AdenocarcinomaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Early Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 8 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02896907
Sponsor's protocol ID: 16D.347
Other IDs: JT 8223
Status last verified: Apr 2025
First submitted: 6 Sep 2016
Last updated: 30 Apr 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 1/2
Testing the Addition of a New Anti-cancer Drug, M3814 (Peposertib), to the Usual Radiotherapy in Patients With Locally Advanced Pancreatic Cancer
Locally Advanced Pancreatic Adenocarcinoma, Stage III Pancreatic Cancer AJCC v8
RecruitingPhase 2
APOLLO: A Randomized Phase II Double-Blind Study of Olaparib Versus Placebo Following Curative Intent Therapy in Patients With Resected Pancreatic Cancer and a Pathogenic BRCA1, BRCA2 or PALB2 Mutation
Pancreatic Acinar Cell Carcinoma, Pancreatic Adenosquamous Carcinoma
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors
Advanced/Metastatic Solid Tumors, Bladder Cancer
RecruitingPhase 2
Neoadjuvant Folfirinox Combined With Pembrolizumab Followed by Surgery for Patients With Resectable Pancreatic Cancer
Pancreatic Ductal Adenocarcinoma
Active, not recruitingPhase 1
P-MUC1C-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With Advanced or Metastatic Solid Tumors
Breast Cancer, Ovarian Cancer

All Pancreatic Adenocarcinoma trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Pilot Study of Intravenous Ascorbic Acid and Folfirinox in the Treatment of Advanced Pancreatic Cancer
ClinicalTrials.gov ID: NCT02896907
Acronym / sponsor ID: 16D.347
Conditions: Pancreatic Adenocarcinoma, Recurrent Pancreatic Carcinoma, Stage III Pancreatic Cancer, Stage IV Pancreatic Cancer, Unresectable Pancreatic Carcinoma
Phase: Early Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 8 participants (actual)
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson UniversityUniversity, hospital or other
Study start: 18 Oct 2016 (actual)
Primary completion: 22 Mar 2018 (actual)
Study completion: Mar 2019 (actual)
First posted: 12 Sep 2016 (estimated)
Results: Posted 18 Jan 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

PRIMARY OBJECTIVES:

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:

To test feasibility of collecting quality of life (QOL), patient reported outcomes (PRO) data and correlative studies on patients with advanced pancreatic cancer.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Treatment (FOLFIRINOX, ascorbic acid)	Experimental	Drug: Oxaliplatin, Drug: Irinotecan Hydrochloride, Drug: Leucovorin Calcium, Drug: Fluorouracil, Dietary Supplement: Ascorbic AcidPatients 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.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (13 listed)

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

Key exclusion criteria (10 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
OxaliplatinAlso: Diaminocyclohexane Oxalatoplatinum, Eloxatin, Dacotin, DacplatGiven IV	Drug	Treatment (FOLFIRINOX, ascorbic acid)
Irinotecan HydrochlorideAlso: 136572-09-3, Campto, Camptosar, Camptothecin 11Given IV	Drug	Treatment (FOLFIRINOX, ascorbic acid)
Leucovorin CalciumAlso: 1492-18-8, 3590, 5-Formyl Tetrahydrofolate, 5-Formyl-5,6,7,8-tetrahydrofolic AcidGiven IV	Drug	Treatment (FOLFIRINOX, ascorbic acid)
FluorouracilAlso: 19893, 2,4-Dioxo-5-fluoropyrimidine, 5-Fluoro-2,4(1H, 3H)-pyrimidinedione, 5-FluorouracilGiven IV	Drug	Treatment (FOLFIRINOX, ascorbic acid)
Ascorbic AcidAlso: 2-(1,2-dihydroxyethyl)-4,5-dihydroxy-furan-3-one, 33832, 50-81-7, AsorbicapGiven IV	Dietary supplement	Treatment (FOLFIRINOX, ascorbic acid)

Primary outcome

Number of Participants With Adverse Events as Determined by CTCAE Version 4.03
Time frame: Up to 28 days after the last treatment
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.

1 secondary outcome

Change in Quality of Life as Defined by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C-30
Time frame: Baseline to up to 28 days after the last treatment

Results and safety

Results posted to the registry on 18 Jan 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment (FOLFIRINOX, Ascorbic Acid)	8	8

Primary outcome: Number of Participants With Adverse Events as Determined by CTCAE Version 4.03

Time frame: Up to 28 days after the last treatment. Count of participants. Unit: Participants

Measure	Treatment (FOLFIRINOX, Ascorbic Acid) n = 8
Grade 4 adverse event	1
Grade 5 adverse event	1
Grade 3 adverse event	4
No Serious Adverse Events	2

1 secondary outcome is reported in the full results.

Adverse events

Time frame: baseline through 30 days after completing treatment; an average of 4 months.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment (FOLFIRINOX, Ascorbic Acid)	6 of 8 (75%)	0 of 8 (0%)	6 of 8

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Thomas Jefferson University HospitalLink provided by the sponsor.

Related trials for Pancreatic Adenocarcinoma

Active, not recruitingPhase 1/2
Testing the Addition of a New Anti-cancer Drug, M3814 (Peposertib), to the Usual Radiotherapy in Patients With Locally Advanced Pancreatic Cancer
Locally Advanced Pancreatic Adenocarcinoma, Stage III Pancreatic Cancer AJCC v8
RecruitingPhase 2
APOLLO: A Randomized Phase II Double-Blind Study of Olaparib Versus Placebo Following Curative Intent Therapy in Patients With Resected Pancreatic Cancer and a Pathogenic BRCA1, BRCA2 or PALB2 Mutation
Pancreatic Acinar Cell Carcinoma, Pancreatic Adenosquamous Carcinoma
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors
Advanced/Metastatic Solid Tumors, Bladder Cancer
RecruitingPhase 2
Neoadjuvant Folfirinox Combined With Pembrolizumab Followed by Surgery for Patients With Resectable Pancreatic Cancer
Pancreatic Ductal Adenocarcinoma
Active, not recruitingPhase 1
P-MUC1C-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With Advanced or Metastatic Solid Tumors
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

James Posey, MD principal investigator

Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Adverse Events as Determined by CTCAE Version 4.03 (time frame: Up to 28 days after the last treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02896907.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2025.