Trials / Withdrawn
WithdrawnNCT01954732
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
- Status
- Withdrawn
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Case Comprehensive Cancer Center · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Stage IA Pancreatic Cancer
- Stage IB Pancreatic Cancer
- Stage IIA Pancreatic Cancer
- Stage IIB Pancreatic Cancer
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | metformin hydrochloride | Given PO |
| OTHER | pharmacological study | Correlative studies |
Timeline
- Start date
- 2014-01-01
- Primary completion
- 2015-03-01
- Completion
- 2015-03-01
- First posted
- 2013-10-07
- Last updated
- 2015-07-15
Source: ClinicalTrials.gov record NCT01954732. Inclusion in this directory is not an endorsement.