NCT00954525

Intravenous Vitamin C in Combination With Standard Chemotherapy for Pancreatic Cancer

Phase I, Open Label, Dose Escalating Study of Intravenous Ascorbic Acid in Combination With Gemcitabine and Erlotinib in the Treatment of Metastatic Pancreatic Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Metastatic Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	Gemcitabine and Erlotinib	Gemcitabine (dose according to study protocol), Erlotinib (100 mg/day)
DIETARY_SUPPLEMENT	Intravenous Vitamin C	50 grams, 75 grams, or 100 grams of intravenous vitamin C, three times per week for 8 weeks.

Timeline

• Start date: 2009-07-01
• Primary completion: 2011-12-01
• Completion: 2011-12-01
• First posted: 2009-08-07
• Last updated: 2025-05-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study