Ignite Creation Date:
2025-12-24 @ 9:42 PM
Ignite Modification Date:
2026-01-01 @ 10:49 PM
Study NCT ID:
NCT01954732
Status:
WITHDRAWN
Last Update Posted:
2015-07-15
First Post:
2013-09-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Metformin Hydrochloride in Treating Patients With Pancreatic Cancer That Can be Removed by Surgery
Sponsor:
Case Comprehensive Cancer Center
Organization:
Study Overview
Official Title:
A Pharmacodynamic Study of Metformin in Patients With Resectable Pancreatic Cancer
Status:
WITHDRAWN
Status Verified Date:
2015-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Slow accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
PRIMARY OBJECTIVES:
I. To determine the effect of escalating doses of metformin (metformin hydrochloride) given pre-operatively on pancreatic cancer cell proliferation and apoptosis.
SECONDARY OBJECTIVES:
I. To assess toxicity of escalating doses of metformin given pre-operatively in patients with resectable pancreatic carcinoma.
II. To measure the effect of metformin on the expression of phosphorylated acetyl-CoA carboxylase alpha (ACC), phosphorylated mechanistic target of rapamycin (serine/threonine kinase) (mTOR), and pancreatic cancer stem cells.
OUTLINE: Patients are randomized to 1 of 3 treatment groups.
GROUP I: Patients undergo observation.
GROUP II: Patients receive metformin hydrochloride orally (PO) twice daily (BID) for at least 7 days in the absence of disease progression or unacceptable toxicity.
GROUP III: Patients receive metformin hydrochloride as in Group II.
After completion of study treatment, patients are followed up 30 days.
I. To determine the effect of escalating doses of metformin (metformin hydrochloride) given pre-operatively on pancreatic cancer cell proliferation and apoptosis.
SECONDARY OBJECTIVES:
I. To assess toxicity of escalating doses of metformin given pre-operatively in patients with resectable pancreatic carcinoma.
II. To measure the effect of metformin on the expression of phosphorylated acetyl-CoA carboxylase alpha (ACC), phosphorylated mechanistic target of rapamycin (serine/threonine kinase) (mTOR), and pancreatic cancer stem cells.
OUTLINE: Patients are randomized to 1 of 3 treatment groups.
GROUP I: Patients undergo observation.
GROUP II: Patients receive metformin hydrochloride orally (PO) twice daily (BID) for at least 7 days in the absence of disease progression or unacceptable toxicity.
GROUP III: Patients receive metformin hydrochloride as in Group II.
After completion of study treatment, patients are followed up 30 days.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2013-01836 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| CASE 1213 | OTHER | Case Comprehensive Cancer Center | View | |
| P30CA043703 | NIH | None | https://reporter.nih.gov/quic… | View |