Jefferson Health

Assessing the Efficacy and Safety of Intravenous Vitamin C in Combination with Standard Chemotherapy for Pancreatic Cancer

IRB Protocol #: 11D.365

Description:

  • Intravenous Ascorbic Acid (Vitamin C) is a widely used alternative cancer treatment.
  • The purpose of this study is to determine whether participants receiving a standard chemotherapy of gemcitabine and erlotnib for pancreatic cancer with high doses of Vitamin C will be beneficial and well tolerated.
  • The primary goal is to better evaluate the response to the dosage and combination of therapies and confirm the initial safety data collected in Phase I.
  • This study will be administered at Thomas Jefferson University Hospital and will enroll up to 35 patients.

Procedure:

  • Intravenous Vitamin C treatments will be given three times per week for an initial cycle of 15 weeks, with each treatment taking up to 2 hours.
  • Standard chemotherapy with Gemicitabine will be administered intravenously once a week for the full duration of the cycle.
  • Erlotnib will be taken by mouth on a daily basis.
  • All treatments and scans will be provided free of charge to the participant.

Inclusion Criteria:

  • Males and Females Age > 18
  • Persons with unresectable pancreatic cancer (stage IV) who have had surgery are eligible if the subject has fully recovered and at least 14 days have passed since the surgery for pancreatic cancer
  • Cannot be pregnant or breastfeeding
  • Cannot be on any concurrent anticancer chemotherapy
  • Must receive treatment of gemcitabine and erlotnib at Thomas Jefferson University Hospital

Contact Information:

Michael J. Matthews
215-503-7329
michael.matthews@jefferson.edu

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