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

Metastatic Adenocarcinoma of the Pancreas Clinical Trial

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.

Status Terminated

Clinical Trial 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.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Adenocarcinoma
• Metastatic Adenocarcinoma of the Pancreas

• NCT number: NCT01654861
• Study type: Interventional
• Source: Eastern Regional Medical Center
• Status: Terminated
• Phase: Phase 1
• Start date: June 2012
• Completion date: June 2014