Clinical Trial: Stereotactic Radiosurgery and Metformin Hydrochloride in Treating Patients With Borderline-Resectable or Locally-Advanced Pancreatic Cancer

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

Brief 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 Summary:

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.


Sponsor: Case Comprehensive Cancer Center

Current Primary Outcome: Dose-limiting toxicity (DLT) rate scored according to the National Cancer Institute Common Toxicity Criteria version 4 [ Time Frame: Up to 21 days post-treatment ]

The rate of DLT for each treatment group will be estimated based on the number of incidences using a binomial distribution and its confidence intervals will be estimated using Wilson's method. The factors associated with DLT will be identified using logistic regression using forward model selection procedure


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Clinical response rate using the revised Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 [ Time Frame: Up to 2 years ]
    Using a binomial distribution and its confidence intervals will be estimated using Wilson's method.
  • Progression-free survival using the revised RECIST version 1.1 [ Time Frame: Time from start of treatment to time of progression or death, whichever occurs first, assessed up to 2 years ]
    The factors associated with progression-free survival will be identified using logistic regression using forward model selection procedure.
  • Overall survival [ Time Frame: Up to 2 years ]
    The probability of overall survival along with median survival for each treatment group will be estimated using Kaplan-Meier method.


Original Secondary Outcome: Same as current

Information By: Case Comprehensive Cancer Center

Dates:
Date Received: May 30, 2014
Date Started: May 8, 2015
Date Completion: October 2017
Last Updated: April 24, 2017
Last Verified: April 2017