NCT01364805

New Treatment Option for Pancreatic Cancer

Translation of in Vitro and in Vivo Ascorbate Research Into a New Treatment Option for Pancreatic Cancer: Phase I/IIa Clinical Trial

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Jeanne Drisko, MD, CNS, FACN · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

In the United States, approximately 30,000 new cases of pancreatic cancer are diagnosed each year and an almost equal number of deaths are related to this cancer. Different types of chemotherapeutic treatments are used that target different parts of the cancer cell with some success, but there is room for other treatment options. It is known that people with cancer are using high doses of intravenous vitamin C also known as ascorbate, as a cancer treatment and this is occurring frequently. When Vitamin C is given in this manner, it is not taken by mouth; instead, it enters your body through an IV (intravenous) site, or tube that is inserted through a needle into your vein. If you have a port-a-cath in place, the IV will be given using your port. When Vitamin C enters your body through an IV site, it is known that it acts like a drug and not a vitamin. It produces a substance around the cancer cells called hydrogen peroxide. It has been seen in animal research studies that hydrogen peroxide kills the cancer cells while leaving the normal cells unharmed. Currently the FDA does not approve the use of high-dose intravenous Vitamin C as a cancer treatment. The use of intravenous Vitamin C in this study is experimental. Furthermore, it is important to know that we do not expect the intravenous Vitamin C given in this study to be healing for the treatment of your cancer.

Detailed description

The purpose of this study is to determine if it is safe to give Vitamin C by the vein at high doses to people with pancreatic cancer and if Vitamin C interferes with how well the chemotherapy works on cancer cells. This study will also look at how the body processes of Vitamin C. This study will also help researchers to learn more about long Vitamin C stays in the blood stream, and how rapidly it is used by the body.

Conditions

• Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	Intravenous Vitamin C	The first 5 study visits will all take place in the General Clinical Research Center (GCRC). During these visits you will receive IV doses of Vitamin C. The dose of Vitamin C will be started at 25 grams and may be increased up to 125 grams over a two week period. There may be changes in the amount of Vitamin C that you receive based on your blood test levels. The study staff will go over this in more detail with you. The amount of fluid you receive depends on the dose and can be from 2 1/3 cups to 5 cups.
DRUG	Gemcitabine	Participants receive dexamethasone 10 mg as pretreatment antiemetic; may be given ondansetron, granisetron, or dolasetron, per oncologist. Gemcitibane 1,000mg/m2 IV over 30 minutes Q 21 days. Cycle of treatment: infusions once weekly for 2 consecutive weeks followed by 1 week of rest to continue treatment schedule until they experience disease progression or unacceptable toxicity. CR, PR or SD: treatment will be continued for at least 6 cycles. Discontinuation of therapy may be considered if agreed upon by the participant and oncologist. Dose Modifications: If the patient experiences more than one toxicity, each requiring a dose reduction, follow the guidelines that give the largest dose reduction for the drug. Subsequent doses can be adjusted to as low as 500 mg/m2 for gemcitabine.

Timeline

• Start date: 2011-04-01
• Primary completion: 2015-10-01
• Completion: 2015-10-01
• First posted: 2011-06-02
• Last updated: 2018-06-19

Locations

1 site across 1 country: United States