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Gemcitabine

Paclitaxel

Albumin-Bound Paclitaxel

Ascorbic Acid

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Vitamin C

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

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

Administered intravenously the same day as nab-paclitaxel and ascorbate Administered after nab-paclitaxel and before ascorbate

* given for 3 weeks out of the 4 week cycle
* standard dose reductions are used
* up to 2 cycles are administered before standard of care CT scan
* decision to continue therapy is based disease response to therapy as measured from the CT scan
* treatment continues until disease progression is identified

Administered intravenously the same day as nab-paclitaxel and ascorbate Administered after before gemcitabine and ascorbate

* given for 3 weeks out of the 4 week cycle
* standard dose reductions are used
* up to 2 cycles are administered before standard of care CT scan
* decision to continue therapy is based disease response to therapy as measured from the CT scan
* treatment continues until disease progression is identified

nab-paclitaxel

Administered intravenously the same day as nab-paclitaxel and gemcitabine Administered after nab-paclitaxel and gemcitabine

* given 3 times weekly
* given for 4 weeks out of the 4 week cycle
* no dose reductions are used
* up to 2 cycles are administered before standard of care CT scan
* decision to continue therapy is based disease response to therapy as measured from the CT scan
* treatment continues until disease progression is identified

Pharmacological ascorbate

Joseph J. Cullen, MD, FACS

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).

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.

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

A Phase II Trial of Pharmacological Ascorbate, Gemcitabine, and Nab-Paclitaxel for Metastatic Pancreatic Cancer (PACMAN 2.1)

Data will be shared per consent document, governing Federal regulations and institutional policies, and only after a signed sharing agreement between the sponsor and the requesting investigator.

Time, measured in months, from the start of chemotherapy (C1D1) to death from any cause.

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.

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.

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.

Spots Global Cancer Trial Database for pharmacologic ascorbate