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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)

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

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

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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.

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

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%

Dehydration

24%

Hypokalaemia

24%

Dyspnoea

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%

Arthralgia

14%

Dysgeusia

14%

Anxiety

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

Gastrooesophageal reflux disease

Platelet count decreased

Chills

Urinary tract infection

Non-cardiac chest pain

Dysphagia

Hypocalcaemia

Pneumonia

Hyperglycaemia

Dry skin

Vision blurred

Dysphonia

Hypertension

Insomnia

Blood creatinine increased

Musculoskeletal chest pain

Atrial fibrillation

Asthenia

Upper respiratory tract infection

Delirium

Pulmonary embolism

Mental status changes

Pleural effusion

Syncope

Chronic obstructive pulmonary disease

Ileus

Deep vein thrombosis

Pain

Spinal column stenosis

Seizure

Cardiac arrest

Febrile neutropenia

Small intestinal obstruction

Acute kidney injury

Cachexia

Hypoxia

Hyponatraemia

Oropharyngeal pain

Diverticulitis

Chest pain

Atrial thrombosis

Haemoptysis

Pancreatitis acute

Acute respiratory failure

Atrial flutter

Pancreatitis

Leukocytosis

Pericardial effusion

Myocardial infarction

Rectal haemorrhage

Bronchitis

Bone pain

Encephalopathy

Respiratory failure

Overdose

Contusion

100%

80%

60%

40%

20%

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

0 / 4Eligibility criteria met

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

2,705 Previous Clinical Trials

7,507,156 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,680 Previous Clinical Trials

40,928,454 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