Gemcitabine, Ascorbate, Radiation Therapy for Pancreatic Cancer, Phase I
This phase 1 study will test the safety of adding high dose ascorbate (vitamin C) to
standard chemoradiation. The ascorbate is infused during external beam radiation therapy
For patients eligible for this trial, standard treatment for their cancer includes radiation
therapy combined with weekly gemcitabine (a chemotherapy).
- receive high doses of intravenous (IV) ascorbate during their daily radiation therapy
treatments. Radiation treatments are given once a day, Monday through Friday.
- have routine doctor's visits and be asked about any side effects they are experiencing.
This is a phase 1 study that will evaluate the side effects of adding ascorbate to standard
therapy. The dose given to a participant will be determined by how well other participants
have tolerated ascorbate.
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of grade 3, 4, & 5 adverse events during radiation
Assess grade 3 and higher adverse events. Evaluate the frequency and severity against the published literature to determine the likely causality between ascorbate and the adverse event(s).
Weekly during therapy for up to 10 weeks
Joseph J. Cullen, MD
The University of Iowa Hospitals & Clinics
United States: Food and Drug Administration
|The Holden Comprehensive Cancer Center||Iowa City, Iowa 52242|