Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gemcitabine and Erlotinib | Drug | — | UNRESOLVED |
| Intravenous Vitamin C | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Intravenous Vitamin C
- interventionNames
- Drug: Gemcitabine and Erlotinib
- Dietary Supplement: Intravenous Vitamin C
Primary outcomes (1)
- measure
- Safety, assessed by toxicity (graded by NCI CTC), urinalysis, ECG, basic metabolic panel, CBC, and osmolality.
- timeFrame
- 8 weeks
Secondary outcomes (1)
- measure
- Progression-free survival
- timeFrame
- 8 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDMonti 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. PMID 22272248