A Randomized Phase II Trial of Ascorbic Acid in Combination with Docetaxel in Men with Metastatic Prostate Cancer

The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Ascorbic acid (vitamin C) is being used by complementary medicine practitioners to treat cancer, infections, and other conditions. Annual administration of more than 355,000 doses of intravenous (I.V.) ascorbic acid for more than 10,000 patients has been documented. Phase I and II clinical trials in 2012, 2013, and 2014 demonstrated safety and anti-tumor activity for high dose I.V. ascorbic acid.

These studies warranted testing the efficacy of I.V. ascorbic acid in randomized, placebo controlled clinical trials. At high concentrations, which can only be achieved with I.V. dosing but not oral use, ascorbic acid no longer acts as an anti-oxidant, but becomes a pro-oxidant that causes DNA damage and metabolic stress in tumor cells, provoking cell death. Normal cells have been shown to be unaffected by these reactions. This creates the specificity by which high dose I.V. ascorbic acid is selectively toxic to tumor cells but not normal tissues, and underlies the safety of I.V. ascorbic acid. 

A recent study of high dose I.V. ascorbic acid in ovarian cancer patients indicated that ascorbic acid treatment combined with standard chemotherapy (paclitaxel) reduces certain toxicities associated with chemotherapy and might increase survival. Dr. Channing Paller is conducting a randomized phase II clinical trial comparing docetaxel plus I.V. ascorbic acid (1g/kg, 2 times per week) versus docetaxel plus I.V. fluid (placebo) in mCRPC patients. The primary outcomes will be PSA response and reduction of chemotherapy-related toxicities. Key secondary outcomes include radiographic progression free survival, safety, quality of life, and the need for dose reductions of docetaxel.

This clinical trial was launched in 2016 at Johns Hopkins University in Baltimore and Washington, and is currently opening at partnering sites including Thomas Jefferson University in Philadelphia, Karmanos Cancer Center in Detroit, and University Hospitals of Cleveland. To find out if this clinical trial might be right for you or your patient, please call 410.955.8964 to schedule an appointment. Each patient must be seen in person to determine eligibility. 

Contact: Channing Paller, MD

Full text detail on Clinical Trial

Partnering sites: 
John Hopkins University
Thomas Jefferson University
Karmanos Cancer Center
University Hospitals of Cleveland
The Sidney Kimmel Comprehensive Cancer Center

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