NCT02153450

Stereotactic Radiosurgery and Metformin in Patients With Borderline-Resectable or Locally-Advanced Pancreatic Cancer

A Pilot Trial of Stereotactic Body Radiation Therapy and Metformin for Borderline-Resectable and Locally-Advanced Pancreatic Adenocarcinomas

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Case Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This pilot clinical trial studies stereotactic radiosurgery and metformin hydrochloride in treating patients with pancreatic cancer that may be removed (borderline-resectable) or not removed by surgery. Stereotactic radiosurgery may be able to send x-rays directly to the tumor and cause less damage to normal tissue. Metformin hydrochloride, used for diabetes, may also kill cancer cells as demonstrated in laboratory studies. Giving stereotactic radiosurgery with metformin hydrochloride may kill more tumor cells.

Detailed description

This is an open label pilot, single-center, non-randomized trial is designed to evaluate the tolerability and preliminary activity of the combination of stereotactic body radiation therapy (SBRT) with metformin for resectable and locally-advanced pancreatic/periampullary cancers. PRIMARY OBJECTIVES: The primary objectives of this study are to: 1\) To determine if the addition of metformin to SBRT adds minimal additional toxicity for patients with A). borderline-resectable or B). not surgically resectable pancreatic adenocarcinomas. SECONDARY OBJECTIVES: I. Evaluate the clinical/pathological response and resectability rates associated with these regimens. OUTLINE: Patients receive metformin hydrochloride orally (PO) daily or twice daily (BID) on days -11 to -1. Patients then undergo stereotactic radiosurgery 5 days a week for 5 weeks and receive concurrent metformin hydrochloride\* by mouth, two times a day for 5 weeks. Patients undergo laparotomy on week 6 (or weeks 5-7). ). Systemic therapy continues as soon as it is considered feasible by the treating physicians. \*NOTE: Metformin hydrochloride should be stopped 2 days before laparotomy. After completion of study treatment, patients are followed up every 3 months for 2 years.

Conditions

• Acinar Cell Adenocarcinoma of the Pancreas
• Duct Cell Adenocarcinoma of the Pancreas
• Recurrent Pancreatic Cancer
• Stage I-III Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	metformin hydrochloride	Given PO
RADIATION	stereotactic radiosurgery	Undergo stereotactic radiosurgery

Timeline

• Start date: 2015-05-08
• Primary completion: 2018-08-03
• Completion: 2020-06-13
• First posted: 2014-06-03
• Last updated: 2020-06-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study