Metformin Plus Modified FOLFOX 6 in Metastatic Pancreatic Cancer

Status Completed

Clinical Trial 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

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Acinar Cell Adenocarcinoma of the Pancreas
Adenocarcinoma
Duct Cell Adenocarcinoma of the Pancreas
Pancreatic Neoplasms
Recurrent Pancreatic Cancer
Stage IV Pancreatic Cancer

Clinical Trial Details

NCT number	NCT01666730
Study type	Interventional
Source	Case Comprehensive Cancer Center
Contact
Status	Completed
Phase	Phase 2
Start date	February 21, 2013
Completion date	August 1, 2018

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