Status:
COMPLETED
Gemcitabine, Ascorbate, Radiation Therapy for Pancreatic Cancer, Phase I
Lead Sponsor:
Joseph J. Cullen
Collaborating Sponsors:
Holden Comprehensive Cancer Center
Gateway for Cancer Research
Conditions:
Pancreatic Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 e...
Eligibility Criteria
Inclusion
- Patients must have histologically or cytologically diagnosed pancreatic adenocarcinoma. Documentation of disease extent by CT scan is required. Radiologically measurable disease is not required.
- Age ≥ 18 years
- ECOG performance status 0, 1, or 2 (Karnofsky \> 50%).
- A complete blood count and differential must be obtained within 21 days prior to radiation fraction 1, with adequate bone marrow functions as defined below:
- Absolute neutrophil count (ANC) ≥ 1500 cells per mm3
- Platelets ≥ 100,000 per mm3
- Leukocytes ≥ 3,000 per mm3
- Serum blood chemistries within 21 days of radiation fraction 1, as defined below:
- Creatinine ≤ 1.5 x UIHC upper limit of normal or creatinine clearance of at least 60 ml/min/1.73 m2 for patients with creatinine levels above institutional normal.
- Total bilirubin ≤ 2 x UIHC upper limit of normal
- ALT ≤ 2.5 times the UIHC upper limit of normal
- AST ≤ 2.5 times the UIHC upper limit of normal
- PT/INR within normal limits (UIHC)
- Tolerate one test dose (15g) of ascorbate.
- Not pregnant.
- Ability to understand and willingness to sign a written informed consent document.
Exclusion
- G6PD (glucose-6-phosphate dehydrogenase) deficiency.
- Prior abdominal radiotherapy that would result in overlap of fields. The treating radiation oncologist should review prior RT fields as available.
- Adjuvant therapy (including radiation therapy) within 2 calendar weeks. Toxicities from prior therapy for the malignancy should resolve to grade 1 or less.
- Patients actively receiving insulin are excluded.
- Patients who are on the following drugs and cannot have a drug substitution: flecainide, methadone, amphetamines, quinidine, and chlorpropamide. High dose ascorbate may affect urine acidification and, as a result, may affect clearance rates of these drugs.
- Second malignancy other than non-melanoma skin cancers within the past 5 years.
- Other investigational agents/therapy with the intention to treat the disease under study (observational or imaging trials are acceptable).
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, psychiatric illness/social situations, or any other condition that would limit compliance with study requirements as determined by study team members.
- Pregnant or lactating women: The risks of radiation and chemotherapy to a fetus are well documented.
- Known HIV-positive individuals. High-dose ascorbate acid is a known CYP450 3A4 inducer, which results in lower serum levels of antiretroviral drugs. A clinical trial designed to address these interaction issues is more appropriate than this phase 1 study.
Key Trial Info
Start Date :
January 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 14 2025
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT01852890
Start Date
January 1 2014
End Date
October 14 2025
Last Update
October 24 2025
Active Locations (1)
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1
The Holden Comprehensive Cancer Center
Iowa City, Iowa, United States, 52242