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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
Pathologic diagnosis (cell samples, biopsy, brushing, surgical sample) of adenocarcinoma of the pancreas. Cancer from the Ampullae of Vater is also eligible. The tissue sample can be from a metastatic location, like a lymph node.
Metastatic or node positive disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every 2 months for up to 20 years post-treatment
Awards & highlights
No Placebo-Only Group

Study 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
Select...
My cancer diagnosis is pancreatic adenocarcinoma or Ampullae of Vater cancer, confirmed by a tissue sample.
Select...
My cancer has spread to other parts of my body or to my lymph nodes.
Select...
I have a cancer site not treated with radiation, visible and at least 1 cm on a CT scan.
Select...
My doctor has recommended gemcitabine and nab-paclitaxel for my treatment.
Select...
My initial cancer treatment didn't work or I can't have surgery or radiation to cure it.
Select...
My kidney function tests are within the required range.

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
68%
Fatigue
66%
Anaemia
59%
Peripheral sensory neuropathy
51%
Neutropenia
47%
Nausea
44%
Thrombocytopenia
43%
Diarrhoea
40%
Alopecia
37%
Constipation
32%
Decreased appetite
24%
Cough
24%
Dyspnoea
24%
Epistaxis
24%
Dehydration
21%
Leukopenia
21%
Neutrophil count decreased
21%
Stomatitis
21%
Dizziness
19%
Vomiting
18%
Oedema peripheral
16%
Hyponatraemia
15%
Hypokalaemia
13%
Weight decreased
13%
Platelet count decreased
13%
Abdominal pain
12%
Hypomagnesaemia
12%
Back pain
12%
Insomnia
12%
Rash maculo-papular
10%
Headache
10%
Hyperglycaemia
10%
Pain in extremity
10%
Asthenia
10%
Urinary tract infection
10%
Dysgeusia
10%
Peripheral motor neuropathy
9%
Upper respiratory tract infection
9%
Dry skin
9%
Pain
9%
Overdose
7%
White blood cell count decreased
7%
Muscular weakness
7%
Pyrexia
7%
Musculoskeletal chest pain
7%
Gastrooesophageal reflux disease
7%
Fall
7%
Arthralgia
7%
Haemoptysis
6%
Dysphagia
6%
Contusion
6%
Hypocalcaemia
6%
Oral candidiasis
6%
Oropharyngeal pain
6%
Pneumonia
6%
Hypotension
4%
Non-cardiac chest pain
4%
Vision blurred
3%
Anxiety
3%
Febrile neutropenia
3%
Syncope
3%
Pulmonary embolism
1%
Deep vein thrombosis
1%
Odynophagia
1%
Sepsis
1%
Sinus tachycardia
1%
Chills
1%
Hypertension
1%
Dysphonia
1%
Acute myocardial infarction
1%
Atrial fibrillation
1%
Atrial tachycardia
1%
Diarrhoea infectious
1%
Serratia infection
1%
Gastrointestinal haemorrhage
1%
Generalised oedema
1%
Gallbladder obstruction
1%
Femur fracture
1%
Hyperbilirubinaemia
1%
Clostridium difficile colitis
1%
Aspartate aminotransferase increased
1%
Femoral neck fracture
1%
Oesophageal candidiasis
1%
Alanine aminotransferase increased
1%
Hypoglycaemia
1%
Blood alkaline phosphatase increased
1%
Pneumonitis
1%
Renal failure
1%
Orthostatic hypotension
1%
Blood creatinine increased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm A: Nab-Paclitaxel and Carboplatin (21-day Treatment Cylce)
Arm B: Nab-Paclitaxel and Carboplatin (28-day Treatment Cycle)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
2,662 Previous Clinical Trials
6,694,277 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,565 Previous Clinical Trials
41,223,735 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the scope of the current cohort engaged in this trial?

"Affirmative. Data hosted on clinicaltrials.gov verifies that this medical experiment, which originally went live on November 28th 2018, is actively recruiting. Approximatively 65 patients need to be enlisted from a single health centre."

Answered by AI

What risks accompany administration of nab-paclitaxel?

"Nab-paclitaxel's safety has been established in some capacity, so it was assigned a rating of 2. However, there is yet to be clinical proof that this drug can effectively treat the target condition."

Answered by AI

Are there any other studies that have utilized nab-paclitaxel as a therapeutic agent?

"At present, there are 1158 clinical trials for nab-paclitaxel currently in progress with 329 of them entering Phase 3. These experiments span the globe with locations in Shanghai, Beijing and 59856 other cities."

Answered by AI

What diseases or illnesses can nab-paclitaxel be employed to alleviate?

"nab-paclitaxel is typically utilized for the remediation of iron deficiency anemia. It can likewise be employed to mitigate conditions like vitamin a lack, locally advanced pancreatic adenocarcinoma, and metastatic melanoma."

Answered by AI

Are there any spaces available in this research project?

"Clinicaltrials.gov confirms that this medical research is currently enrolling participants, with the first posting dating to November 28th 2018 and an update occurring on July 7th 2022."

Answered by AI

Who else is applying?

What state do they live in?
Wisconsin
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
~17 spots leftby Dec 2025