NCT01654861

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

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Eastern Regional Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Metastatic Adenocarcinoma of the Pancreas

Interventions

Type	Name	Description
DRUG	Gemcitabine, Intravenous and oral Ascorbic Acid (Vitamin C)	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.

Timeline

• Start date: 2012-06-01
• Primary completion: 2014-06-01
• Completion: 2014-06-01
• First posted: 2012-08-01
• Last updated: 2018-07-26
• Results posted: 2014-12-01

Locations

1 site across 1 country: United States