Clinical trial · Interventional
A Research Trial of High Dose Vitamin C and Chemotherapy for Metastatic Pancreatic Cancer
A Phase I Trial of Ascorbic Acid and Gemcitabine for the Treatment of Metastatic Pancreatic Cancer
NCT01049880CI-TRIAL-00027107completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- 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)
This study is designed to determine the maximum tolerated dose of vitamin C when given with a standard chemotherapy for people who have metastatic pancreatic cancer.
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 |
|---|---|---|---|
| Pancreatic Neoplasms | Pancreatic Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gemcitabine with escalating ascorbic acid | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Ascorbate
- interventionNames
- Drug: Gemcitabine with escalating ascorbic acid
Primary outcomes (1)
- measure
- Blood cell counts (neutropenia, thrombocytopenia) and serum chemistries (liver function tests, creatinine)
- timeFrame
- weekly
Secondary outcomes (2)
- measure
- Plasma ascorbate level (targeted to 350 to 400 mg/dL)
- timeFrame
- Weekly
- measure
- Survival
- timeFrame
- Ongoing
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Normal G6PD status * Histologically or cytologically diagnosed pancreatic adenocarcinoma. * Disease extent documented by CT scan (radiologically measurable disease is not required) * Ambulatory patient without evidence of spinal cord compression * No prior chemotherapy for metastatic disease * Failed curative therapy or patient ineligible for definitive curative therapy * Completed adjuvant therapy at least 4 weeks prior and recovered from any/all toxicities related to that treatment. * If post-therapy, must have disease progression since that treatment * If treated with prior radiation therapy, disease must be outside of the radiation fields * No currently active second malignancies unless it is a non-melanoma skin cancer * Women must be non-pregnant and non-lactating * ECOG performance of 0, 1, or 2 * Granulocytes at least 1,500 / ul * Platelets at least 100,000 / ul * Creatinine less than 1.5 mg/dL or clearance of at least 60 mL / min * Total bilirubin less than 2 times the upper limit of normal * AST and ALT less than 3 times the upper limit of normal if liver metastases are not present. If liver metastases are present, AST and ALT less than 5 times the upper limit of normal * PT INR less than 1.5 (unless the patient is on full dose warfarin) * Patient must be at least 18 years of age * Patient must be able to understand consent process, the research study, and be able to sign the consent document Exclusion Criteria: * A psychiatric disorder by history or examination that would prevent completion of the study * ECOG performance of 3 or 4 * Co-morbid conditions that affect survival: end stage congestive heart failure, unstable angina, myocardial infarction (within the past 6 weeks), uncontrolled blood sugars of greater than 300 mg/dL, known chronic active hepatitis or cirrhosis. * Consumption of excess alcohol (more than 4 drinks per day) or use of illicit drugs * Continued sse of over-the-counter antioxidants (supplements like vitamin C and grape seeds)
References
Publications (1)
- RESULTWelsh JL, Wagner BA, van't Erve TJ, Zehr PS, Berg DJ, Halfdanarson TR, Yee NS, Bodeker KL, Du J, Roberts LJ 2nd, Drisko J, Levine M, Buettner GR, Cullen JJ. Pharmacological ascorbate with gemcitabine for the control of metastatic and node-positive pancreatic cancer (PACMAN): results from a phase I clinical trial. Cancer Chemother Pharmacol. 2013 Mar;71(3):765-75. doi: 10.1007/s00280-013-2070-8. Epub 2013 Feb 5. PMID 23381814