Phase II, Open Label Study of Intravenous Ascorbic Acid in Combination With Gemcitabine and Erlotinib in the Treatment of Metastatic Pancreatic Cancer
Intravenous high dose ascorbic acid is a widely used alternative cancer treatment. Patients
will receive standard care gemcitabine/erlotinib for treatment of their metastatic
pancreatic adenocarcinoma. They will be closely monitored for disease response/ progression.
If vitamin C has a beneficial effect on tumour cells, patients may experience a regression
of tumor or tumor markers. Additional benefits include scans at no charge to the patient.
This study requires several days of treatment per week and treatments are given in two
different locations. The intravenous vitamin C treatments are given 3 times per week, these
are given every week for an initial cycle of 15 weeks.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Safety of ascorbic acid in combination with gemcitabine and erlotinib for stage IV Pancreatic cancer
To assess safety of IVAA in combination with gemcitabine and erlotinib by evaluating the number of adverse events and serious adverse events occurring among study participants
Daniel A Monti, MD
Thomas Jefferson University
United States: Food and Drug Administration
|Thomas Jefferson University||Philadelphia, Pennsylvania 19107-6541|