drugset / Trial / NCT01515046
Clinical Trial of High-dose Vitamin C for Advanced Pancreatic Cancer
Phase 2
Terminated
1 enrolled
Joseph J. Cullen
Holden Comprehensive Cancer Center · collabNational Cancer Institute (NCI) · collabSusan L Bader Foundation of Hope · collab
NaSingle-groupOpen-labelTreatment
Summary
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.
Timeline
- Start
- 2012-09
- Primary completion
- 2015-07
- Completion
- 2016-12
Outcome
Outcome not reported
Stopped (Enrollment): “Standard of care changed to FOLFIRINOX; poor accrual.”
Publications
- Background Cullen JJ. Ascorbate induces autophagy in pancreatic cancer. Autophagy. 2010 Apr;6(3):421-2. doi: 10.4161/auto.6.3.11527. Epub 2010 Apr 15.
- Background Du J, Martin SM, Levine M, Wagner BA, Buettner GR, Wang SH, Taghiyev AF, Du C, Knudson CM, Cullen JJ. Mechanisms of ascorbate-induced cytotoxicity in pancreatic cancer. Clin Cancer Res. 2010 Jan 15;16(2):509-20. doi: 10.1158/1078-0432.CCR-09-1713. Epub 2010 Jan 12.
- Background Welsh JL, Wagner BA, van't Erve TJ, Zehr PS, Berg DJ, Halfdanarson TR, Yee NS, Bodeker KL, Du J, Roberts LJ 2nd, Drisko J, Levine M, Buettner GR, Cullen JJ. Pharmacological ascorbate with gemcitabine for the control of metastatic and node-positive pancreatic cancer (PACMAN): results from a phase I clinical trial. Cancer Chemother Pharmacol. 2013 Mar;71(3):765-75. doi: 10.1007/s00280-013-2070-8. Epub 2013 Feb 5.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Vitamin C | Other / unclassified | 15 g | Intravenous |
| Background | Gemcitabine | Small molecule | 1000 mg/m2 | — |