Safety & Efficacy Study of Gemcitabine...With High Dose IV Vit. C (HDIVC)
Status:
Terminated
Trial end date:
2014-06-01
Target enrollment:
Participant gender:
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.