Gemcitabine, Ascorbate, Radiation Therapy for Pancreatic Cancer, Phase I
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 30
Summary
- Conditions
- Pancreatic Neoplasms
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: Non-RandomizedIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 ...
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.
Tracking Information
- NCT #
- NCT01852890
- Collaborators
- Holden Comprehensive Cancer Center
- Gateway for Cancer Research
- Investigators
- Principal Investigator: Joseph J Cullen, MD, FACS The University of Iowa Hospitals & Clinics
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