Clinical trial · Interventional
Metformin Hydrochloride in Treating Patients With Pancreatic Cancer That Can be Removed by Surgery
A Pharmacodynamic Study of Metformin in Patients With Resectable Pancreatic Cancer
NCT01954732CI-TRIAL-00018550withdrawnPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- 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)
This randomized clinical trial studies metformin hydrochloride in treating patients with pancreatic cancer that can be removed by surgery. Metformin hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Conditions
Conditions (4)
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 IA Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_BROADER | 0.78 |
| Stage IB Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIA Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIB Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| metformin hydrochloride | Drug | Metformin | ALIAS |
| pharmacological study | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- NO_INTERVENTION
- label
- Group I (observation)
- description
- Patients undergo observation.
- type
- EXPERIMENTAL
- label
- Group II (metformin hydrochloride)
- description
- Patients receive metformin hydrochloride PO BID for at least 7 days in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: metformin hydrochloride
- Other: pharmacological study
- type
- EXPERIMENTAL
- label
- Group III (metformin hydrochloride)
- description
- Patients receive metformin hydrochloride as in Group II.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients must have histologically or cytologically confirmed resectable pancreatic carcinoma; patients with pancreatic neuroendocrine tumors are not eligible * Patients must be previously untreated with chemotherapy or radiation therapy * Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 * Patients must have surgical resection of the pancreas planned, with enrollment at least 7 days prior to surgery; patients with surgery scheduled \> 15 days will not be excluded * Hemoglobin (Hg)A1C must be below 7% * Total bilirubin less than 1.5 X institutional upper limit of normal * Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\]) =\< 2.5 X institutional upper limit of normal * Alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 2.5 X institutional upper limit of normal * Serum creatinine within normal institutional limits * Alkaline phosphatase \< 1.5 X institutional upper limit of normal * Subjects must have the ability to understand and be willing to provide written informed consent Exclusion Criteria: * History of metformin use in the previous 3 months * Treatment with neoadjuvant chemotherapy or radiation therapy * History of allergic reactions attributed to metformin * Patients with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements * Metabolic acidosis, acute or chronic, including ketoacidosis * Metastatic disease
References
Publications (0)
Data not yet available
No reference posted for this study.