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METformin With a caRbOhydrate Restricted Diet in Combination With Platinum Based Chemotherapy in Stage IIIB/IV Non-squamous Non-small Cell Lung Cancer

2014-10-06 18:08:21 | BioPortfolio

Summary

Subjects, who are eligible for the study, will be treated with four cycles of carboplatin AUC of 5 IV and pemetrexed 500mg/m2 IV every 21 days +/- 2 days as per the standard of care. Subjects who have not progressed after four cycles by radiological assessment (partial response or stable disease) will receive single agent pemetrexed 500mg/m2 IV q 21 days +/- 2 days as maintenance therapy and as the standard of care until disease progression or subject cannot tolerate.

Metformin will be given as 500 mg pills starting on day 1 of chemotherapy. Starting dose will 500mg po bid (1000mg/day). If tolerating (see below for dose reduction), the dose will be escalated to 1000mg po qam and 500mg po qpm (1500mg/day) from days 8 to 14. If still tolerating, the dose will be escalated to 2 500mg pills twice a day for a total dose of 2000mg/day from days 15 until end of the study. This dose has been found to be safe in healthy controls and in subjects treated with chemotherapy.

Description

Metformin, an oral biguanide agent used for the treatment of non-insulin-dependent diabetes mellitus, is now prescribed to more than 120 million people worldwide. Its glucose lowering effects result from both inhibition of liver gluconeogenesis and increased insulin sensitivity in peripheral tissue[5]. Metformin has limited adverse effects with little or no risk of hypoglycemia in healthy, nondiabetic controls. In addition to its anti-diabetic properties, metformin has demonstrated both chemopreventative and therapeutic effects in both prostate and breast cancer.

The role of metformin as a preventative and therapeutic agent in lung cancer is beginning to be assessed. A recent epidemiological study from Taiwan demonstrated a 39-45% decreased risk of lung cancer in diabetic patients being treated with antidiabetic drugs including metformin versus those not taking these agents[12]. These studies have triggered preclinical and clinical observational trials that further support metformin's potential as an antineoplastic agent. Two observational studies in humans have reinforced metformin's potential role as a therapeutic agent in lung cancer. In the first, Mezzone et al. showed that diabetic patients with lung cancer previously treated with metformin or thiazolidinediones had a lower incidence of metastatic disease at the time of diagnosis and a reduced risk of death compared to those who did not receive the same treatment[15]. More recently, a retrospective study performed by Tan et al. evaluated the outcomes of three groups of diabetic patients with NSCLC treated with first line chemotherapy and receiving various diabetic drugs. In this study, patients treated with chemotherapy with metformin had superior outcomes compared to those patients treated with chemotherapy with insulin or with drugs other than metformin (OS, 20 months vs. 13.1 months vs 13.0 months, respectively, p=0.007)[16]. The remarkable activity of this agent in both preclinical and clinical lung cancer models as well as its low toxicity and tolerability in non- diabetic patients warrants further prospective studies evaluating the therapeutic efficacy with platinum based chemotherapy in NSCLC.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Carcinoma, Non-squamous Non-small-cell Lung

Intervention

Metformin, Carboplatin, Pemetrexed

Location

Moun Sinai Beth Israel Comprehensive Cancer Center
New York
New York
United States
10011

Status

Recruiting

Source

Beth Israel Medical Center

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-10-06T18:08:21-0400

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