Clinical Trial: Metformin Plus Modified FOLFOX 6 in Metastatic Pancreatic Cancer

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

Official Title: A Phase II Study of Metformin Plus Modified FOLFOX 6 in Patients With Metastatic Pancreatic Cancer

Brief Summary: This phase II trial studies how well metformin hydrochloride, leucovorin calcium, fluorouracil, and oxaliplatin work in treating patients with metastatic pancreatic cancer. Metformin hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as leucovorin calcium, fluorouracil, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving metformin hydrochloride together with combination chemotherapy may kill more tumor cells

Detailed Summary:

PRIMARY OBJECTIVES:

I. To determine if metformin (metformin hydrochloride) when added to FOLFOX ( leucovorin calcium, fluorouracil, oxaliplatin) improves overall survival in patients with metastatic pancreatic cancer.

SECONDARY OBJECTIVES:

I. To assess response rate (RR). II. To assess progression free survival (PFS). III. To assess toxicity in patients with metastatic pancreatic cancer receiving FOLFOX and metformin. IV. To identify tumor/serum correlative markers.

OUTLINE: Patients receive metformin hydrochloride orally (PO) twice daily (BID) on days 1-7 for an introductory period before the addition of FOLFOX. After the introductory period, patients will continue metformin twice daily and FOLFOX therapy comprising leucovorin calcium intravenously (IV) over 120 minutes, fluorouracil IV continuously over 46 hours, and oxaliplatin IV over 120 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for periodically.

Current Primary Outcome: Median overall survival (OS) [ Time Frame: Time from first day of treatment to death from any cause, assessed up to 1 year ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Response Rate (RR) objective tumor response based on computed tomography (CT) scans or magnetic resonance imaging (MRI) scans according to Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: 1 year ]
  The overall response is the number of participants who experience a confirmed complete (CR) or partial response (PR) of the total analysis population. Per the Response Evaluation Criteria In Solid Tumors (RECIST): CR = all detectable tumor has disappeared, PR = a >=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum, Progressive disease (PD) = a >=20% increase in target lesions, Stable Disease = small changes that do not meet previously given criteria. The true response rate of the combination therapy for this patient population will be estimated based on the number of response using a binomial distribution and its confidence intervals will be estimated using Wilson's method.
• Progression free survival according to RECIST 1.1 Criteria [ Time Frame: Time from first day of treatment received to the earlier documented disease progression or death from any cause, assessed up to 1 year ]
  Calculated using Kaplan Meier methods and the median will be estimated assuming an exponential distribution.
• Number of grade 3 and 4 toxicities according to NCI CTCAE version 4.0 [ Time Frame: Up to 1 year ]
  The toxicity profile of the combination will be tabulated.

Original Secondary Outcome: Same as current

Information By: Case Comprehensive Cancer Center

Dates:
Date Received: August 14, 2012
Date Started: February 2013
Date Completion: December 2017
Last Updated: September 29, 2016
Last Verified: September 2016