Clinical trial · Interventional
Assessing the Efficacy and Safety of IV Vitamin C in Combination With Standard Chemotherapy for Pancreatic Ca
Phase II, Open Label 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
Why stopped (as posted): Slow accrual
Summary
Brief summary (as posted)
The investigators recently completed a phase I study of intravenous ascorbic acid (IV AA) plus standard chemotherapy (gemcitabine and erlotinib) in patients with metastatic pancreatic cancer. The investigators determined that the target ceiling dosage of 100 grams of ascorbic acid is safe when given with the chemotherapy. This Phase II trial is an initial test of efficacy of the 100 gram dose of ascorbic acid, which will be given with the same standard chemotherapy. This open label study will recruit up to 35 subjects with metastatic pancreatic cancer who will receive ascorbic acid combined with gemcitabine and erlotinib as front-line treatment. The phase I data suggests that ascorbic acid when given in combination with gemcitabine and erlotinib may result in some tumor response, and the goal of this study is to better evaluate the response and confirm initial safety data
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 |
|---|---|---|---|
| Stage IV Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ascorbic Acid | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Ascorbic Acid, Gemcitabine & Erlotinib
- description
- Ascorbic Acid (50-100g, 3x weekly) Standard Chemotherapy of Gemcitabine and Erlotinib for Pancreatic Cancer
- interventionNames
- Drug: Ascorbic Acid
Primary outcomes (1)
- measure
- Safety of Ascorbic Acid in Combination With Gemcitabine and Erlotinib for Stage IV Pancreatic Cancer
- timeFrame
- 15 weeks
- description
- Safety: to assess safety of IVAA in combination with gemcitabine and erlotinib by evaluating the number of adverse events and serious adverse events occurring among study participants.
Secondary outcomes (1)
- measure
- Evaluate Quality of Life Using Functional Assessment of Cancer Therapy-General (FACT-G) Quality Assessment Instrument
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Males and females of age ≥ 18 * Histologically or cytologically confirmed pancreatic adenocarcinoma that has metastatic disease measurable by CT, MRI, or PET * Subjects with unresectable pancreatic cancer who have had surgery (exploratory laparotomy, biliary, gastrointestinal bypass) are eligible, if the subject has fully recovered from surgery and ≥ 14 days has passed since the operation. Patients with history of pancreatoduodenectomy are eligible provided that there is radiographically documented disease recurrence. * ECOG performance status 0-2 * Laboratory values that would not prevent the patient from receiving chemotherapy as determined by the PI or study oncologist * G6PD status ≥ lower limit of normal * Serum creatinine ≤ 2.0 mg/dL Exclusion Criteria: * Islet cell or acinar cell carcinoma or cystadenocarcinoma * History or known presence of central nervous system (CNS) metastases * History of another primary cancer, except: * Curatively treated cervical carcinoma in situ, or * Curatively resected non-melanomatous skin cancer, or * Other primary solid tumor curatively treated with no known active disease present and no treatment administered for ≥ 3 years prior to enrollment * Other concurrent anticancer chemotherapy * Prior radiotherapy ≤ 14 days, or if subjects have not recovered from radiotherapy * Uncontrolled seizure disorder or other serious neurological diseases * Any co-morbid disease that would increase risk of toxicity as determined by PI * Only locally advanced disease * Prior treatment with gemcitabine (for metastatic pancreatic cancer) * Subjects requiring chronic use of immunosuppressive agents (eg, methotrexate, cyclosporine, corticosteroids) * Recent infection requiring a course of systemic anti-infection that was completed ≤ 14 days prior to enrollment (exception can be made at the judgment of the PI for oral treatment of an uncomplicated urinary tract infection (\[UTI\]) * History of any medical or psychiatric condition or addictive disorder, or laboratory abnormality that, in the opinion of the PI, may increase the risks associated with study participation or study drug administration or may interfere with the conduct of the study or interpretation of study requirements * Subject unwilling or unable to comply with study requirements * Subject who is pregnant or breast feeding * Known positive test(s) for human immunodeficiency virus infection, hepatitis C virus, chronic active hepatitis B infection * Documented history of alcohol, cocaine or intravenous drug abuse ≤ 6 months of enrollment
References
Publications (1)
- BACKGROUNDMonti 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