Gemcitabine + Vitamin C + Radiation for Pancreatic Cancer
What You Need to Know Before You Apply
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.
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.
Is the combination of Gemcitabine and radiation therapy safe for humans?
What makes the Gemcitabine + Vitamin C + Radiation treatment unique for pancreatic cancer?
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.1261011
Who Is on the Research Team?
Joseph J Cullen, MD, FACS
Principal Investigator
The University of Iowa Hospitals & Clinics
Are You a Good Fit for This Trial?
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 for a Trial Participant
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
What Are the Treatments Tested in This Trial?
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