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).
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
- SECONDARY ID:
P01CA217797
- NCT ID:
NCT02905578
Conditions
- Pancreatic Neoplasms
- Cancer of Pancreas
- Cancer of the Pancreas
- Neoplasms, Pancreatic
- Pancreas Cancer
- Pancreas Neoplasms
- Adenocarcinoma
Interventions
Drug | Synonyms | Arms |
---|
Gemcitabine | Gemzar, Gemcitabine Hydrochloride | Ascorbate group |
nab-paclitaxel | Abraxane | Ascorbate group |
Pharmacological ascorbate | Ascorbate, Vitamin C, Ascorbic acid | Ascorbate 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
Name | Type | Description | Interventions |
---|
Ascorbate group | Experimental | 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 | - Gemcitabine
- nab-paclitaxel
- Pharmacological ascorbate
|
Control | Active Comparator | 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 | - 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
July 8, 2021