Jefferson Health

Phase I/II Study of Intravenous Vitamin C in Combination with Irinotecan Versus Irinotecan Alone for Advanced Colorectal Cancer

IRB Protocol #: 11D.459

Description:

  • 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.

Procedure:

  • 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.

Inclusion Criteria:

  • 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
215-503-7329
michael.matthews@jefferson.edu

More information is available at http://www.clinicaltrials.gov