drugset / Trial / NCT00954525

Intravenous Vitamin C in Combination With Standard Chemotherapy for Pancreatic Cancer

NCT00954525

NaSingle-groupOpen-labelTreatment

Summary

Eligible candidates will be adults with metastatic pancreatic cancer (confirmed diagnosis with pathology reports and measurable computed tomography (CT) or magnetic resonance imaging (MRI)). Participants must not be receiving any other concurrent chemotherapy, or radiation therapy. Full inclusion/exclusion criteria are available. History and physical examination, and laboratory and imaging analyses will be done within 14 days prior to registration. The three cohorts of subjects will receive 50, 75 or 100 grams of intravenous ascorbic acid, three times per week for 8 weeks. Subjects will also have co-administration of the chemotherapy medications, gemcitabine (intravenously) and erlotinib (orally). Approximately 9 to 18 participants will be enrolled in this Phase I study.

Timeline

Start
2009-07
Primary completion
2011-12
Completion
2011-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Vitamin C Other / unclassified 50 g Intravenous
Subject Vitamin C Other / unclassified 75 g Intravenous
Subject Vitamin C Other / unclassified 100 g Intravenous
Background Erlotinib Small molecule 100 mg Oral
Background Gemcitabine Small molecule Intravenous