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Gemcitabine, Ascorbate, Radiation Therapy for Pancreatic Cancer, Phase I

Phase 1
18 Years
Not Enrolling
Pancreatic Neoplasms

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Trial Information

Gemcitabine, Ascorbate, Radiation Therapy for Pancreatic Cancer, Phase I

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

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.

Inclusion Criteria:

- 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

- 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 Criteria:

- 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 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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of grade 3, 4, & 5 adverse events during radiation

Outcome Description:

Assess grade 3 and higher adverse events. Evaluate the frequency and severity against the published literature to determine the likely causality between ascorbate and the adverse event(s).

Outcome Time Frame:

Weekly during therapy for up to 10 weeks

Safety Issue:


Principal Investigator

Joseph J. Cullen, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

The University of Iowa Hospitals & Clinics


United States: Food and Drug Administration

Study ID:




Start Date:

December 2013

Completion Date:

December 2017

Related Keywords:

  • Pancreatic Neoplasms
  • Ascorbate
  • Vitamin C
  • Radiation
  • Gemcitabine
  • Ascorbic Acid
  • Neoplasms
  • Pancreatic Neoplasms



The Holden Comprehensive Cancer Center Iowa City, Iowa  52242