Spots Global Cancer Trial Database for Safety & Efficacy Study of Gemcitabine...With High Dose IV Vit. C (HDIVC)

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Trial Identification

Brief Title: Safety & Efficacy Study of Gemcitabine...With High Dose IV Vit. C (HDIVC)

Official Title: Evaluation of the Safety and Efficacy of Standard Dose Gemcitabine Combined With High Dose Intravenous Vitamin C (HDIVC) Treatment for Patients With Metastatic Adenocarcinoma of the Pancreas.

Study ID: NCT01654861

Conditions

Metastatic Adenocarcinoma of the Pancreas

Interventions

Gemcitabine, Intravenous and oral Ascorbic Acid (Vitamin C)

Study Description

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: