NCT01666730

Metformin Plus Modified FOLFOX 6 in Metastatic Pancreatic Cancer

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Case Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

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

Interventions

Type	Name	Description
DRUG	metformin hydrochloride	Given PO
DRUG	oxaliplatin	Given IV
DRUG	leucovorin calcium	Given IV
DRUG	fluorouracil	Given IV
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2013-02-21
• Primary completion: 2018-08-01
• Completion: 2018-08-01
• First posted: 2012-08-16
• Last updated: 2021-08-10
• Results posted: 2021-08-10

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study