Gemcitabine + Vitamin C + Radiation for Pancreatic Cancer
Trial Summary
Will I have to stop taking my current medications?
The trial requires that you stop taking certain medications, such as insulin and specific drugs like flecainide, methadone, amphetamines, quinidine, and chlorpropamide, unless a substitution can be made. If you are on these medications, you may need to discuss alternatives with your doctor.
What data supports the effectiveness of the treatment Gemcitabine combined with radiation therapy for pancreatic cancer?
Research shows that Gemcitabine, when combined with radiation therapy, is effective in treating localized, unresectable pancreatic cancer. Studies indicate that Gemcitabine has radiosensitizing properties, meaning it can make cancer cells more sensitive to radiation, potentially improving treatment outcomes.12345
Is the combination of Gemcitabine and radiation therapy safe for humans?
What makes the Gemcitabine + Vitamin C + Radiation treatment unique for pancreatic cancer?
What is the purpose of this trial?
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.
Research Team
Joseph J Cullen, MD, FACS
Principal Investigator
The University of Iowa Hospitals & Clinics
Eligibility Criteria
This trial is for adults over 18 with pancreatic adenocarcinoma, who can tolerate a test dose of vitamin C and have normal liver function, blood clotting, kidney function, and white blood cell count. They must not be pregnant or on certain drugs like insulin or methadone that can't be replaced.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive high doses of intravenous ascorbate during daily radiation therapy treatments, along with weekly gemcitabine
Follow-up
Participants are monitored for safety and effectiveness after treatment, with adverse events assessed monthly
Long-term follow-up
Participants are monitored for disease progression and overall survival
Treatment Details
Interventions
- Ascorbate
- Gemcitabine
- Radiation therapy
Gemcitabine is already approved in European Union, United States, Canada, Japan for the following indications:
- Pancreatic cancer
- Breast cancer
- Ovarian cancer
- Non-small cell lung cancer
- Pancreatic cancer
- Breast cancer
- Ovarian cancer
- Non-small cell lung cancer
- Pancreatic cancer
- Breast cancer
- Ovarian cancer
- Non-small cell lung cancer
- Pancreatic cancer
- Breast cancer
- Ovarian cancer
- Non-small cell lung cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
Joseph J. Cullen
Lead Sponsor
Gateway for Cancer Research
Collaborator
Holden Comprehensive Cancer Center
Collaborator