Clinical trialPhase 2Terminated
Clinical Trial of High-dose Vitamin C for Advanced Pancreatic Cancer
Pharmacological Ascorbate for the Control of Metastatic and Node-Positive Pancreatic Cancer (PACMAN): A Phase II Trial
- Outcome
- Stopped earlyStandard of care changed to FOLFIRINOX; poor accrual. (Enrollment)
- Phase
- Phase 2
- Status
- Terminated
- Study type
- Interventional
- Start
- September 2012
- Expected end
- December 2016
- Enrollment
- 1 participants
- Sites
- 1
- Primary outcomes
- Overall Survival
- Sponsor
- Other
- Results posted
- 2017-03-29
- Last update
- 8 June 2017
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Brief summary public domain (ClinicalTrials.gov)
This is a phase II study. It is designed to provide information about if high-dose ascorbate (vitamin C) increases survival for pancreatic cancer patients. The hypothesis is that vitamin C is well tolerated and increases cancer treatment effectiveness, lengthening survival time for patients with advanced pancreatic cancer.
Detailed description public domain (ClinicalTrials.gov)
Adenocarcinoma of the pancreas is the fourth leading cause of cancer death in the United States and is increasing in incidence; the prognosis remains dismal. We propose to investigate an entirely new approach, using pharmacological ascorbate, combined with Gemcitabine, to treat this cancer. Intravenous ascorbate (i.e., ascorbic acid, vitamin C), but not oral ascorbate, produces high plasma concentrations, which are in the range that can be cytotoxic to tumor cells. Though ascorbate has been utilized in cancer therapy, few studies have investigated intravenous deliver of ascorbate. Preliminary studies from our group have demonstrated that ascorbate induces oxidative stress and cytotoxicity in pancreatic cancer cells; this cytotoxicity appears to be greater in tumor vs. normal cells. We hypothesize that production of H2O2 mediates the increased susceptibility of pancreatic cancer cells to ascorbate-induced metabolic oxidative stress. Gemcitabine is the standard chemotherapy drug used to treat pancreatic cancer.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Overall Survival [up to 5 years]. Number, days. Gemcitabine With Escalating IV Ascorbate (n=1): 268.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Progression Free Survival [up to 5 years]. Number, days. Gemcitabine With Escalating IV Ascorbate (n=1): 80.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Number of Drug-related Adverse Events Per Cycle [every 28 days up to 5 years]. Gemcitabine With Escalating IV Ascorbate (n=0): 0.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
F2-isoprostane Levels [Once every 28 days for up to 5 years].
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Ascorbate Levels [Once every 28 days up to 5 years].