Metformin and Carbohydrate Restriction With Platinum Based Chemotherapy In Stage IIIB/IV Non-Squamous Non-Small Cell Lung Cancer (NS-NSCLC)

Stopped early · Phase 2

Conditions studied: Non-small Cell Lung Cancer Stage IIIB/IV, Non-small Cell Lung Cancer Metastatic, Nonsquamous Nonsmall Cell Neoplasm of Lung

In brief

Metformin is thought to activate AMP-activated protein kinase (AMPK), a major sensor of cellular energy levels and a key enzyme limiting cellular growth during times of cellular stress. Once activated, this enzyme restricts anabolic processes such as protein, cholesterol and fatty acid synthesis and inhibits mTOR, a protein kinase responsible for unregulated growth. MTOR is upregulated in a variety of tumors, including NSCLC providing rationale to take advantage of this pathway with metformin.

Key facts

Study ID

NCT02019979

Run by

Beth Israel Medical Center

People needed

14

Starts

2013-12-01

Expected to finish

2016-12-01

Last updated by the study team

2018-05-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Able to provide written consent and is amenable to compliance with protocol schedules and testing
• Patient is > 18 years of age
• Pathologically proven (either histologic or cytologic) diagnosis of Stage IIIB or IV non-squamous non-small cell lung cancer
• No prior, palliative chemotherapy for stage IV lung cancer Patients who have received adjuvant chemotherapy post surgery for curative intent more than 12 months prior to development of stage IV disease are allowed.
• Measurable disease as RECIST criteria 1.1 (Response Evaluation Criteria in Solid Tumors, Version 1.1)
• CT Scan of the chest/abdomen/pelvis or PET Scan within 30 days of study entry
• An MRI of the brain or Head CT Scan with contrast within 30 days of study entry if clinically indicated
• ECOG Performance Status 0-2.
• CBC/differential obtained within 2 weeks prior to registration on study, with adequate bone marrow function defined as follows:
• Absolute neutrophil count (ANC) >1,500 cells/ul
• Platelets > 100,000 cells/ul
• Hemoglobin > 9.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb > g/dl is acceptable.)
• Serum creatinine < 1.5 x ULN
• Total bilirubin < 2.0 times the institutional Upper Limit of Normal (ULN)
• AST and ALT < 3.0 x the ULN
• Women of childbearing potential must have:
• A negative serum or urine pregnancy test (sensitivity <= 25IU HCG/L) within 14 days prior to the start of study drug administration
• Persons of reproductive potential must agree to use and utilize an adequate method of contraception throughout treatment and for at least 90 days after study drug is stopped prior to study enrollment, women of childbearing potential must be advised of the importance of avoiding pregnancy during trial participation and the potential risk factors for an unintentional pregnancy.
• Ability to take oral medication

You may not qualify if…

• The patient has a diagnosis of squamous cell carcinoma. Adenosquamous (mixed) histologies are allowed
• The patient has a history of type I or type II diabetes
• Weight of less than 80% of (IBW) ideal body weight
• Creatinine clearance less than 45 l/min as calculated by the Cockcroft-Gault equation
• Known EGFR or ALK mutation in which targeted therapy with erlotinib or crizotinib would be the standard of care. Those patients whose tissue is not tested or have insufficient material are eligible
• The patient is currently taking or has previously taken metformin in the past 6 months
• The patient has received previous chemotherapy for NSCLC except in instances of adjuvant therapy post surgical resection more than 12 months prior to enrollment
• The patient has undergone major surgery within four weeks prior to randomization.
• The patient has undergone palliative radiation (chest, brain) to tumor sites within two weeks of randomization (except palliative radiation to the bone which can be within one week
• Uncontrolled (untreated) brain metastasis.
• Patient who has NCI-CTCAE Version 4 Grade >= 2 diarrhea
• That patient has clinically relevant CAD or uncontrolled CHF
• The patient has ongoing or active infection (requiring antibiotics) that would limit the administration of chemotherapy including active TB. HIV is allowed in this study
• The patient has a history of neurological or psychological disorder that may interfere with the compliance of the protocol
• Women who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for at least 4 weeks after cessation of study drug, or have a positive pregnancy test at baseline, or are pregnant or breastfeeding

Where it is running

• Beth Israel Medical Center — New York, New York, United States
• Beth Israel Comprehensive Cancer Center — New York, New York, United States
• St.Luke's-Roosevelt Hospital Center — New York, New York, United States
• Mount Sinai Ichan School of Medicine — New York, New York, United States

Full record on ClinicalTrials.gov

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