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Phase I/II Study of Intravenous Vitamin C in Combination with Irinotecan Versus Irinotecan Alone for Advanced Colorectal Cancer
IRB Protocol #: 11D.459
- Intravenous Vitamin C has shown some positive effects on cancer patients.
- The purpose is to determine whether participants receiving standard chemotherapy of Irinotecan for recurrent or advanced colorectal cancer plus high doses of Vitamin C will be safe and well tolerated and whether this combination is more beneficial compared to Irinotecan alone. The goal is also to assess its effect on the cancer.
- Up to 30 patients may participate in this study at Thomas Jefferson University Hospital.
- Doses of either Vitamin C plus Irinotecan, or Irinotecan alone, will be randomly divided and between participants for a period of nine weeks.
- The Irinotecan will be administered every three weeks at a dose of 350mg/m2 intravenously.
- The Vitamin C will be administered three times per week for the full duration of nine weeks.
- All treatment and scans will be provided free of charge to the participant.
- Age > 18 yrs
- Must have failed one or more prior chemotherapy treatment regimens
- Must receive treatment at Thomas Jefferson University Hospital
- Recurrent or Advanced Colorectal Cancer (Stage IV)
- Cannot be pregnant or breastfeeding
- Cannot be enrolled in another active clinical trial/experimental therapy within the prior 30 days
Contact Information:Michael J. Matthews
More information is available at http://www.clinicaltrials.gov