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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

No Placebo-Only Group

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ every 2 months for up to 20 years post-treatment

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall survival

Secondary study objectives

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%

Stomatitis

21%

Neutrophil count decreased

21%

Dizziness

19%

Vomiting

18%

Oedema peripheral

16%

Hyponatraemia

15%

Hypokalaemia

13%

Abdominal pain

13%

Platelet count decreased

13%

Weight decreased

12%

Hypomagnesaemia

12%

Back pain

12%

Insomnia

12%

Rash maculo-papular

10%

Urinary tract infection

10%

Hyperglycaemia

10%

Pain in extremity

10%

Headache

10%

Asthenia

10%

Dysgeusia

10%

Peripheral motor neuropathy

Upper respiratory tract infection

Pain

Overdose

Dry skin

Gastrooesophageal reflux disease

Pyrexia

White blood cell count decreased

Musculoskeletal chest pain

Muscular weakness

Haemoptysis

Fall

Arthralgia

Oral candidiasis

Contusion

Dysphagia

Hypocalcaemia

Oropharyngeal pain

Pneumonia

Hypotension

Non-cardiac chest pain

Vision blurred

Syncope

Anxiety

Febrile neutropenia

Pulmonary embolism

Generalised oedema

Hyperbilirubinaemia

Serratia infection

Gallbladder obstruction

Diarrhoea infectious

Sepsis

Deep vein thrombosis

Renal failure

Chills

Dysphonia

Hypertension

Sinus tachycardia

Odynophagia

Atrial tachycardia

Gastrointestinal haemorrhage

Acute myocardial infarction

Atrial fibrillation

Femur fracture

Clostridium difficile colitis

Aspartate aminotransferase increased

Femoral neck fracture

Oesophageal candidiasis

Alanine aminotransferase increased

Hypoglycaemia

Blood alkaline phosphatase increased

Pneumonitis

Orthostatic hypotension

Blood creatinine increased

100%

80%

60%

40%

20%

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

~1920

nab-paclitaxel

2008

Completed Phase 4

~1420