Metformin Plus Modified FOLFOX 6 in Metastatic Pancreatic Cancer

Brief summary public domain (ClinicalTrials.gov)

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 public domain (ClinicalTrials.gov)

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.

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Median Overall Survival (OS) [Time from first day of treatment to death from any cause, assessed up to 1 year]. Median, Months (95% Confidence Interval). Treatment (Metformin Hydrochloride, FOLFOX) (n=50): 7.1 (5.0 to 9.2).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

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) [1 year]. Count Of Participants, Participants. Treatment (Metformin Hydrochloride, FOLFOX) (n=31): 4.

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Clinical Benefit Rate (CBR) Based on Computed Tomography (CT) Scans or Magnetic Resonance Imaging (MRI) Scans According to RECIST [1 year]. Count Of Participants, Participants. Treatment (Metformin Hydrochloride, FOLFOX) (n=31): 14.

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Progression Free Survival According to RECIST 1.1 Criteria [Time from first day of treatment received to the earlier documented disease progression or death from any cause, assessed up to 1 year]. Median, Months (95% Confidence Interval). Treatment (Metformin Hydrochloride, FOLFOX) (n=50): 5.1 (1.8 to 6.6).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Number of Grade 3 and 4 Toxicities According to NCI CTCAE Version 4.0 [Up to 1 year]. Number, Events. Grade 3: Treatment (Metformin Hydrochloride, FOLFOX) (n=50): 60. Grade 4: Treatment (Metformin Hydrochloride, FOLFOX) (n=50): 2.