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Brief Title: Gemcitabine, Ascorbate, Radiation Therapy for Pancreatic Cancer, Phase I
Official Title: Gemcitabine, Ascorbate, Radiation Therapy for Pancreatic Cancer, Phase I
Study ID: NCT01852890
Brief Summary: This is a phase 1 (first in man) study testing the safety of adding high dose ascorbate (vitamin C) to standard radiation and chemotherapy for treatment of pancreatic cancer.
Detailed Description: 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 treatment. For patients eligible for this trial, standard treatment for their cancer includes radiation therapy combined with weekly gemcitabine (a chemotherapy). Participants will: * 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
The Holden Comprehensive Cancer Center, Iowa City, Iowa, United States
Name: Joseph J Cullen, MD, FACS
Affiliation: The University of Iowa Hospitals & Clinics
Role: PRINCIPAL_INVESTIGATOR