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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-28

Study Completion Date

2024-08-26

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Ascorbate group

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 Type EXPERIMENTAL

Gemcitabine

Intervention Type DRUG

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

nab-paclitaxel

Intervention Type DRUG

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

Pharmacological ascorbate

Intervention Type DRUG

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

Control

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

Group Type ACTIVE_COMPARATOR

Gemcitabine

Intervention Type DRUG

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

nab-paclitaxel

Intervention Type DRUG

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

Interventions

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Gemcitabine

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

Intervention Type DRUG

nab-paclitaxel

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

Intervention Type DRUG

Pharmacological ascorbate

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

Intervention Type DRUG

Other Intervention Names

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Gemzar Gemcitabine Hydrochloride Abraxane Ascorbate Vitamin C Ascorbic acid

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No