CClinicalTrials.gg
CompletedNCT00954525Updated May 2, 2025

Intravenous Vitamin C in Combination With Standard Chemotherapy for Pancreatic Cancer

A Phase 1 interventional study of Gemcitabine and Erlotinib and Intravenous Vitamin C in Metastatic Pancreatic Cancer, sponsored by Sidney Kimmel Cancer Center at Thomas Jefferson University. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-05-02.

Sponsored by Sidney Kimmel Cancer Center at Thomas Jefferson University · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Dec 2011, 14 years 10 months ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
14
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
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Study 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.

02

Conditions studied

  • Metastatic Pancreatic Cancer

Keywords

  • Pancreatic Cancer
03

In context

Pancreatic Neoplasms

3,235 studies on the registry are indexed under Pancreatic Neoplasms; 899 are open to participants now.

This study's enrollment of 14 is below the median of 46 across 2,424 interventional studies indexed under Pancreatic Neoplasms.

Browse Pancreatic Neoplasms studies →

Lead sponsor

Sidney Kimmel Cancer Center at Thomas Jefferson University is the lead sponsor of 125 studies on the registry; none are open to participants now.

Of its 23 completed or terminated interventional studies of FDA-regulated products, 7 (30%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
14 participants (actual)

Study arms

  • Experimental
    Intravenous Vitamin C

    Drug: Gemcitabine and Erlotinib · Dietary Supplement: Intravenous Vitamin C

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.

06

What researchers measure

Primary outcomes

  1. Safety, assessed by toxicity (graded by NCI CTC), urinalysis, ECG, basic metabolic panel, CBC, and osmolality.

    Time frame: 8 weeks

Secondary outcomes

  1. Progression-free survival

    Time frame: 8 weeks

07

Study locations

1 site
  • Jefferson-Myrna Brind Center of Integrative Medicine
    Philadelphia, Pennsylvania 19107, United States
08

References and documents

Publications

  • Monti DA, Mitchell E, Bazzan AJ, Littman S, Zabrecky G, Yeo CJ, Pillai MV, Newberg AB, Deshmukh S, Levine M. Phase I evaluation of intravenous ascorbic acid in combination with gemcitabine and erlotinib in patients with metastatic pancreatic cancer. PLoS One. 2012;7(1):e29794. doi: 10.1371/journal.pone.0029794. Epub 2012 Jan 17. PubMed 22272248 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 2, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00954525
Lead sponsor
Sidney Kimmel Cancer Center at Thomas Jefferson University
Responsible party
Sponsor
First posted
Aug 7, 2009
Start date
Jul 2009
Primary completion
Dec 2011
Completion
Dec 2011
Last update
May 2, 2025

Study contacts

Daniel Monti, MD, MBA
principal investigator · Sidney Kimmel Cancer Center at Thomas Jefferson University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.

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