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A Phase 2 Trial of High-dose Ascorbate for Pancreatic Cancer (PACMAN 2.1)
Sponsor: University of Iowa
Summary
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).
Official title: A Phase II Trial of Pharmacological Ascorbate, Gemcitabine, and Nab-Paclitaxel for Metastatic Pancreatic Cancer (PACMAN 2.1)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2018-11-28
Completion Date
2024-08-26
Last Updated
2026-07-23
Healthy Volunteers
No
Conditions
Interventions
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
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
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
Locations (1)
Holden Comprehensive Cancer Center
Iowa City, Iowa, United States