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High-Dose Vitamin C + Chemotherapy for Pancreatic Cancer

Phase 2
Waitlist Available
Research Sponsored by Joseph J. Cullen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Failed initial therapy or be ineligible for definitive curative therapy (e.g., surgical excision, radiation therapy)
A creatinine level of less than 1 1/2 times the upper limit of normal for the local lab test, or, a creatinine clearance of at least 60 mL/(min*1.73m2)
Must not have
Patients who are on the following drugs and cannot have a substitution (or who decline the substitution): warfarin, flecainide, methadone, amphetamines, quinidine, chlorpropamide
Prior chemotherapy to treat the metastatic disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every 2 months for up to 20 years post-treatment
Awards & highlights

Summary

This trial is testing whether adding high doses of vitamin C to the standard treatment for pancreatic cancer can improve outcomes.

Who is the study for?
This trial is for adults with metastatic pancreatic adenocarcinoma who are recommended gemcitabine and nab-paclitaxel treatment. They must have a certain platelet count, acceptable kidney function, not be pregnant, use birth control, and cannot have had prior chemotherapy for metastatic disease or other recent treatments.Check my eligibility
What is being tested?
The PACMAN 2.1 study tests high-dose vitamin C (ascorbate) added to standard chemotherapy (gemcitabine and nab-paclitaxel) in patients with advanced pancreatic cancer. Participants are randomly assigned to either the standard treatment group or the one receiving additional ascorbate.See study design
What are the potential side effects?
Potential side effects include those from standard chemotherapy like nausea, fatigue, hair loss, low blood cell counts leading to increased infection risk; plus possible risks of high-dose vitamin C such as gastrointestinal discomfort and kidney stones.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My initial cancer treatment didn't work or I can't have surgery or radiation to cure it.
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My kidney function tests are within the required range.
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I have a cancer site not treated with radiation, visible and at least 1 cm on a CT scan.
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My cancer has spread to other parts of my body or to my lymph nodes.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am taking medication like warfarin or methadone and cannot change it.
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I have received chemotherapy for cancer that has spread.
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I do not have any uncontrolled illnesses.
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I have another cancer besides pancreatic that needs treatment.
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I am HIV positive and on treatment that might interact with high-dose vitamin C therapy.
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I have G6PD deficiency.
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I am currently using insulin or have been advised to start using it.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every 2 months for up to 20 years post-treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and every 2 months for up to 20 years post-treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall survival
Secondary outcome measures
Adverse event frequency and categorization
Progression free survival
Tumor Response

Side effects data

From 2017 Phase 4 trial • 143 Patients • NCT02151149
56%
Anaemia
53%
Nausea
53%
Fatigue
46%
Neutropenia
43%
Peripheral sensory neuropathy
41%
Alopecia
37%
Diarrhoea
37%
Decreased appetite
29%
Vomiting
29%
Constipation
27%
Thrombocytopenia
24%
Dyspnoea
24%
Hypokalaemia
24%
Dehydration
20%
Hypomagnesaemia
20%
Dizziness
19%
Weight decreased
19%
Oedema peripheral
19%
Neutrophil count decreased
19%
Muscular weakness
19%
Hypotension
17%
Cough
16%
Peripheral motor neuropathy
16%
Leukopenia
14%
Dysgeusia
14%
Anxiety
14%
Arthralgia
14%
Epistaxis
13%
Abdominal pain
11%
Stomatitis
11%
Rash maculo-papular
11%
Pain in extremity
10%
White blood cell count decreased
10%
Fall
10%
Pyrexia
10%
Back pain
10%
Headache
9%
Platelet count decreased
9%
Gastrooesophageal reflux disease
9%
Chills
9%
Urinary tract infection
7%
Non-cardiac chest pain
7%
Dysphagia
7%
Hypocalcaemia
7%
Pneumonia
7%
Hyperglycaemia
6%
Vision blurred
6%
Dysphonia
6%
Hypertension
6%
Dry skin
6%
Insomnia
6%
Blood creatinine increased
4%
Musculoskeletal chest pain
4%
Atrial fibrillation
4%
Asthenia
4%
Upper respiratory tract infection
3%
Pleural effusion
3%
Delirium
3%
Mental status changes
3%
Pulmonary embolism
3%
Syncope
3%
Chronic obstructive pulmonary disease
1%
Cardiac arrest
1%
Small intestinal obstruction
1%
Spinal column stenosis
1%
Seizure
1%
Ileus
1%
Pain
1%
Deep vein thrombosis
1%
Cachexia
1%
Hyponatraemia
1%
Acute kidney injury
1%
Hypoxia
1%
Oropharyngeal pain
1%
Febrile neutropenia
1%
Diverticulitis
1%
Chest pain
1%
Atrial thrombosis
1%
Haemoptysis
1%
Pancreatitis acute
1%
Acute respiratory failure
1%
Atrial flutter
1%
Pancreatitis
1%
Leukocytosis
1%
Pericardial effusion
1%
Myocardial infarction
1%
Rectal haemorrhage
1%
Bronchitis
1%
Bone pain
1%
Encephalopathy
1%
Respiratory failure
1%
Overdose
1%
Contusion
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm B: Nab-Paclitaxel and Carboplatin (28-day Treatment Cycle)
Arm A: Nab-Paclitaxel and Carboplatin (21-day Treatment Cylce)

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Ascorbate groupExperimental Treatment3 Interventions
Each cycle is 4 calendar weeks Gemcitabine: 1000 mg/m2, once weekly for 3 weeks nab-paclitaxel: 125 mg/m2, once weekly for 3 weeks Pharmacological ascorbate: 75 grams, three times weekly for 4 weeks
Group II: ControlActive Control2 Interventions
Each cycle is 4 calendar weeks Gemcitabine: 1000 mg/m2, once weekly for 3 weeks nab-paclitaxel: 125 mg/m2, once weekly for 3 weeks Each cycle has 1 rest week
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gemcitabine
2017
Completed Phase 3
~2070
nab-paclitaxel
2008
Completed Phase 4
~1330

Find a Location

Who is running the clinical trial?

Joseph J. CullenLead Sponsor
4 Previous Clinical Trials
92 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,736 Previous Clinical Trials
7,507,885 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,748 Previous Clinical Trials
40,959,336 Total Patients Enrolled

Media Library

Pancreatic Cancer Research Study Groups: Ascorbate group, Control
Pancreatic Cancer Clinical Trial 2023: Gemcitabine Highlights & Side Effects. Trial Name: NCT02905578 — Phase 2
Gemcitabine (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02905578 — Phase 2
~13 spots leftby Dec 2025
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