Clinical trial NCT01852890 (phase 1, status: active, not recruiting)
Conditions: pancreatic neoplasms
ICD codes: C25.3
Drugs: ascorbate, gemcitabine
SMILES: [H][C@@]1(OC(=O)C(O)=C1O)[C@@H](O)CO, [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1
Eligibility criteria:

        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 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 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 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.