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COMPLETED
NCT02905578
PHASE2

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

Sponsor: University of Iowa

View on ClinicalTrials.gov

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

Interventions

DRUG

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

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

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

Locations (1)

Holden Comprehensive Cancer Center

Iowa City, Iowa, United States