Phase II Lung Metcore - Preoperative Metformin for Lung Cancer

• Status: Completed
• Trial end date: 2020-08-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a phase II single centre open label single arm pre-operative window of metformin treatment in stage I-IIIa Non small cell lung cancer.

In which patients will be invited to participate by receiving Metformin treatment during 14 to 21 days at 850 mg BID until the day before surgery.

They will be followed closely for any Adverse Events during treatment and 30 days after surgery. During treatment there will be no follow up tests except 1 fasting blood glucose at week 2 of treatment.

Survival data will be prospectively gathered after study treatment has ended until death.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University Health Network, Toronto
• Treatments: Metformin

Criteria

Inclusion Criteria:

• Have biopsy-proven non-small cell lung carcinoma (NSCLC) of any histological variant except for neuroendocrine tumors. Patients must not have mixed NSCLC and small cell lung cancer (SCLC).

• Be of clinical stage I to IIIA (according to the 7th lung cancer TNM classification and staging system) by radiologic and/or pathologic criteria where appropriate (e.g. mediastinoscopic staging). Baseline CT-chest scan must be within 4 weeks of study entry.

• Be deemed appropriate candidates for surgical resection by the treating surgeon and assessing team.

• Be aged - 18 years or more.

• Have ECOG performance status - 2.

• Have organ and marrow function as defined below for safe lung biopsy and administration of metformin:

• Platelets -100 000

• Total bilirubin -1.5 X institutional upper limit of normal

• AST/ALT -2 X institutional upper limit of normal

• Creatinine clearance -60 mL/min/1.73 m2

• Have the ability to understand and the willingness to sign a written informed consent document.

• Not require emergency surgery within 14 days of staging investigations.

• Not have received anticancer treatment with chemotherapy, radiotherapy or Epidermal -
• Growth Factor Receptor (EGFR) inhibitor therapy for the current lung cancer.

• Not have a concomitant active malignancy or be receiving any other investigational or anticancer agents while on the study, to avoid the influence of alternative anti-cancer therapy. Otherwise, those with a past history of cancer are eligible.

Exclusion Criteria:

• Not have a past history of an allergic reaction to metformin.

• Not have a past history of diabetes mellitus or fasting glucose ≥ 7.0 mmol/L.

• Not have a past history of lactic acidosis or metabolic acidosis.

• Not have consumption of ≥ 3 alcoholic beverages per day (average).

• Not have had regular use of agents that may influence insulin sensitivity/levels within 4 weeks of study entry.

• Not have uncontrolled intercurrent illness (es) including but not limited to: ongoing or active:

• Infection,

• Symptomatic congestive

• Cardiac failure or evidence of cardiac dysfunction,

• Unstable angina pectoris,

• Cardiac arrhythmia,

• Active peptic ulcer disease or gastrointestinal conditions (e.g. Inflammatory bowel disease) or

• Psychiatric illness/social situations that would limit compliance with study requirements.

• Not be on a loop diuretic due to their potential to cause renal impairment and predispose to lactic acidosis.

• Not have contrast-enhanced imaging (except when clinically indicated) while on the study. Iodinated contrast agents can cause renal failure, leading to metformin accumulation and lactic acidosis.

• Women should not be pregnant or become pregnant during study.