Conditions: Metastatic Adenocarcinoma of the Pancreas
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 3
Healthy volunteers: no

Brief summary:
* The combination of gemcitabine and HDIVC is safe and may favorably change the clinical course for an individual patient.
* The combination of gemcitabine and HDIVC is synergistic in anti-tumor effect as seen in preclinical models, where HDIVC creates a pro-oxidative effect that adds to the anti-tumor effect of gemcitabine.
* The combination of gemcitabine and HDIVC may improve Progression Free Survival (PFS).
* The dosage schema of 1.2 g /kg bolus infusion followed by lower dose of 0.3 g / kg infusion may create sustained elevation in Vitamin C plasma levels for increased cytotoxic effect.
* The addition of HDIVC \& oral supplementation of Vitamin C to standard treatment with gemcitabine may improve quality of life for patients with comparison to prior to treatment start of this protocol.
* CA 19-9 and inflammatory markers may show trends for patients in this trial.

Detailed description:

Arms:
arm 1: Gemcitabine (Gemzar), Intravenous and oral Ascorbic Acid (Vitamin C).

Interventions: intervention 1: Gemcitabine, Intravenous and oral Ascorbic Acid (Vitamin C)
Intervention descriptions: intervention 1: Weeks 1,2,3: IV Gemcitabine 1000 mg / m² over 30 minutes followed by HDIVC 1.2 g / kg: 1.2 g/kg over 90 minutes for a dose ≤90 g and over 120 minutes for a dose \>90g followed by 0.3 g / kg over 120 minutes; Week 4: no treatment.

Protocol document: