Intravenous Vitamin C in Combination With Standard Chemotherapy for Pancreatic Cancer

Phase 1

Completed

• Conditions: Metastatic Pancreatic Cancer
• Interventions: Drug: Gemcitabine and Erlotinib; Dietary Supplement: Intravenous Vitamin C

• Registration Number: NCT00954525
• Lead Sponsor: Sidney Kimmel Cancer Center at Thomas Jefferson University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07
• Study First Submitted: 2009-08-04
• Study First Submitted QC: 2009-08-05
• Study First Posted: 2009-08-07
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-01
• Last Update Posted: 2025-05-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

• Metastatic pancreatic cancer
• Glucose 6 phosphate dehydrogenase status normal
• ECOG performance status 0-2
• Normal creatinine and transaminase
• Women of child-bearing potential confirm negative pregnancy test

Exclusion Criteria

• Concurrent chemotherapy or radiotherapy
• Significant co-morbid disorders
• Significant psychiatric symptoms
• Prior treatment with gemcitabine
• Concurrent chronic use of immunosuppressive agents (methotrexate, cyclosporine,corticosteroids)
• Regular use of nonsteroidal anti-inflammatory agents
• Smoking more than 1 pack per day
• Excessive alcohol or drug use
• Enrollment in other experimental therapy
• Active infection
• Patients experiencing ongoing response to recent treatments

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intravenous Vitamin C	Gemcitabine and Erlotinib	-
Intravenous Vitamin C	Intravenous Vitamin C	-

Primary Outcome Measures

Name	Time	Method
Safety, assessed by toxicity (graded by NCI CTC), urinalysis, ECG, basic metabolic panel, CBC, and osmolality.	8 weeks

Secondary Outcome Measures

Name	Time	Method
Progression-free survival	8 weeks

Trial Locations

Locations (1)

Jefferson-Myrna Brind Center of Integrative Medicine; 🇺🇸 Philadelphia, Pennsylvania, United States