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

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00954525

Enrollment

Registered

2009-08-07

Start date

2009-07-31

Completion date

2011-12-31

Last updated

2025-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic Pancreatic Cancer

Keywords

Pancreatic Cancer

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.

Interventions

DRUGGemcitabine and Erlotinib

Gemcitabine (dose according to study protocol), Erlotinib (100 mg/day)

DIETARY_SUPPLEMENTIntravenous Vitamin C

50 grams, 75 grams, or 100 grams of intravenous vitamin C, three times per week for 8 weeks.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
Progression-free survival	8 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 27, 2026