Ph 2 Trial of Vitamin C & G-FLIP (Low Doses Gemcitabine, 5FU, Leucovorin, Irinotecan, Oxaliplatin) for Pancreatic Cancer

Summary

Pancreatic cancer, especially at advanced metastatic stage, is a devastating disease. It is the fourth leading cause of cancer death. Its prognosis is grim - 5-year survival rate being 6%. The current therapies for advanced metastatic pancreatic cancer are very toxic and with limited efficacy. A safer and more effective therapy for this devastating disease is greatly needed. G-FLIP regimen is a combination of low doses (doses lower than those approved by the FDA and used in the clinic) of several anti-cancer drugs, Gemcitabine, Fluorouracil, Leucovorin, Irinotecan and Oxaliplatin. The efficacy of G-FLIP against cancers (especially pancreatic cancer) is based on laboratory and clinical results, which indicates the synergistic efficacy of these anti-cancer drugs against cancer cells and overcoming tumor drug resistance that cancer cells frequently develop. Also, because of their low doses, this regimen is less toxic than when these drugs are used alone. Meanwhile, intravenous infusion of high doses (doses significantly higher than the daily nutritional requirements) of Vitamin C (ascorbic acid) has been observed to have anti-cancer activities. This is especially true when Vitamin C is used in combination with other anti-cancer drugs.

Timeline

Start

2014-08-13

Primary completion

2020-01

Completion

2020-01

Publications

• Background Bruckner H, Hirschfeld A, Buddaraju S, Stega J, Jahan M, Schwartz ME. Multidisciplinary effect of adding docetaxel and mitomycin-C to low-dose multidrug therapy for cholangiocarcinoma. J Clin Oncol 29: 2011 (suppl; abstr e14546)
• Background Bruckner HW, Myo M, Zaw K, Filipova O, Heidarian S, Rafiq N, Julliard K. Multi-drug chemotherapy for pancreatic cancer. Journal of Clinical Oncology 2005, 23 (16S. June 1 Supplement):4267 (abstract).
• Background Bruckner H, Simon K, Hrehorovich V. Low-dose sequential multi-drug regimens for advanced pancreatic cancer. Journal of Clinical Oncology, 2008, 26 (15S, May 20 Supplement) 15568 (Abstract)
• Background Monti DA, Mitchell E, Bazzan AJ, Littman S, Zabrecky G, Yeo CJ, Pillai MV, Newberg AB, Deshmukh S, Levine M. Phase I evaluation of intravenous ascorbic acid in combination with gemcitabine and erlotinib in patients with metastatic pancreatic cancer. PLoS One. 2012;7(1):e29794. doi: 10.1371/journal.pone.0029794. Epub 2012 Jan 17.
• Background Goel A, Grossbard ML, Malamud S, Homel P, Dietrich M, Rodriguez T, Mirzoyev T, Kozuch P. Pooled efficacy analysis from a phase I-II study of biweekly irinotecan in combination with gemcitabine, 5-fluorouracil, leucovorin and cisplatin in patients with metastatic pancreatic cancer. Anticancer Drugs. 2007 Mar;18(3):263-71. doi: 10.1097/CAD.0b013e3280121334.

Drugs

Indications