Clinical Trials /

A Phase 2 Trial of High-dose Ascorbate for Pancreatic Cancer (PACMAN 2.1)

NCT02905578

Description:

This clinical trial adds high-dose ascorbate (vitamin C) to the standard of care regimen for metastatic pancreatic adenocarcinoma (a type of pancreatic cancer). Subjects are randomized between a control group (standard treatment) and an intervention group (pharmacologic ascorbate in addition to the standard treatment).

Related Conditions:
  • Ampulla of Vater Adenocarcinoma
  • Pancreatic Adenocarcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: A Phase 2 Trial of High-dose Ascorbate for Pancreatic Cancer (PACMAN 2.1)
  • Official Title: A Phase II Trial of Pharmacological Ascorbate, Gemcitabine, and Nab-Paclitaxel for Metastatic Pancreatic Cancer (PACMAN 2.1)

Clinical Trial IDs

  • ORG STUDY ID: 201801759
  • SECONDARY ID: 3P30CA086862
  • SECONDARY ID: 5U01CA140206
  • NCT ID: NCT02905578

Conditions

  • Pancreatic Neoplasms
  • Cancer of Pancreas
  • Cancer of the Pancreas
  • Neoplasms, Pancreatic
  • Pancreas Cancer
  • Pancreas Neoplasms
  • Adenocarcinoma

Interventions

DrugSynonymsArms
GemcitabineGemzar, Gemcitabine HydrochlorideAscorbate group
nab-paclitaxelAbraxaneAscorbate group
Pharmacological ascorbateAscorbate, Vitamin C, Ascorbic acidAscorbate group

Purpose

This clinical trial adds high-dose ascorbate (vitamin C) to the standard of care regimen for metastatic pancreatic adenocarcinoma (a type of pancreatic cancer). Subjects are randomized between a control group (standard treatment) and an intervention group (pharmacologic ascorbate in addition to the standard treatment).

Detailed Description

      One of the standard treatments for metastatic pancreatic adenocarcinoma is nab-paclitaxel
      with gemcitabine. This standard therapy administers chemotherapy once per week for three
      weeks; patients then get a 'rest week' to complete the cycle (1 cycle = 4 weeks).

      This study adds 75 grams of ascorbate (vitamin C, sometimes called pharamcological ascorbate
      because the dose is so high) to standard therapy. The ascorbate is administered intravenously
      - through a vein in the arm.

      Participants in the control group will:

        -  receive gemcitabine and nab-paclitaxel chemotherapy, which is standard for their cancer.

        -  undergo imaging which is standard for their cancer and therapy. This can include CT
           scans, PET scans, and X-rays

      Participants in the intervention group will:

        -  receive 75 grams of ascorbate 3 times per calendar week for each week of the
           chemotherapy cycle.

        -  undergo imaging which is standard for their cancer and therapy. This can include CT
           scans, PET scans, and X-rays

        -  provide blood samples to determine the biological effects, if any, the ascorbate has on
           the body during therapy.

      This active therapy portion lasts until the disease progresses and a new treatment needs to
      be adopted - this can be months to years. If disease progresses, participants go back to
      standard follow-up for their caner and the new/additional therapy their doctors prescribe.

      However, it is very important we remain in contact with participants; they will have
      life-long follow-up for this study.
    

Trial Arms

NameTypeDescriptionInterventions
Ascorbate groupExperimentalEach 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
  • Gemcitabine
  • nab-paclitaxel
  • Pharmacological ascorbate
ControlActive ComparatorEach 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
  • Gemcitabine
  • nab-paclitaxel

Eligibility Criteria

        Inclusion Criteria:

          -  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

          -  One cancer site, that did not receive radiation therapy, that is at least 1 cm in size
             when looking at it by CT scan (CAT scan)

          -  Recommended to receive gemcitabine and nab-paclitaxel

          -  Failed initial therapy or be ineligible for definitive curative therapy (e.g.,
             surgical excision, radiation therapy)

          -  A platelet count of at least 100,000 cells per mL

          -  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)

          -  Not pregnant

          -  Commit to using birth control during the study (all participants)

        Exclusion Criteria:

          -  Prior chemotherapy to treat the metastatic disease

          -  Other therapy (including radiation) within the past 4 weeks

          -  Side effects from prior therapies that are still deemed moderate to severe by a
             physician

          -  Glucose-6-phosphate dehydrogenase (G6PD) deficiency

          -  Patients actively receiving insulin or who are currently recommended to receive
             insulin by a doctor

          -  Patients requiring daily finger-stick blood glucose measurements

          -  Patients who are on the following drugs and cannot have a substitution (or who decline
             the substitution):

               -  warfarin

               -  flecainide

               -  methadone

               -  amphetamines

               -  quinidine

               -  chlorpropamide

          -  An active cancer, other than the pancreatic cancer, that requires treatment.

          -  Enrolled in another therapeutic clinical trial

          -  Uncontrolled, intercurrent illness

          -  HIV positive individuals undergoing therapy due to known drug:drug interaction between
             antiretroviral drugs and high-dose ascorbate therapy

          -  Women who are nursing
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Overall survival
Time Frame:Every 2 months for up to 20 years post-treatment
Safety Issue:
Description:Time, measured in months, from the start of chemotherapy (C1D1) to death from any cause.

Secondary Outcome Measures

Measure:Tumor Response
Time Frame:Every 2 months for up to 10 years
Safety Issue:
Description:Determine the objective response rate of the disease, assessed every 2 months using CT or MRI, and evaluated/defined using the RECIST criteria (v1.1). Results are provided in nominal categories (CR, PR, SD, PD) as per RECIST.
Measure:Progression free survival
Time Frame:Every 2 months for up to 10 years
Safety Issue:
Description:Time, measured in days, it takes disease to progress, where disease progression is defined by the RECIST criteria (v1.1). Timeframe is from radiation day 1 to date of disease progression.
Measure:Adverse event frequency and categorization
Time Frame:Monthly through 30 days after end of treatment.
Safety Issue:
Description:Categorize and quantify adverse events using the Common Terminology Criteria for Adverse Events (CTCAE v4). Assessments will be monthly through 30 days past the end of therapy.

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Joseph J. Cullen

Trial Keywords

  • Ascorbate
  • Vitamin C
  • Pharmacological ascorbate
  • Pharmacologic ascorbate
  • Ascorbic Acid
  • gemcitabine
  • nab-paclitaxel
  • Gemzar
  • Abraxane

Last Updated

June 19, 2020