Is Clarithromycin a Potential Treatment for Cachexia in People With Lung Cancer?

• Status: Terminated
• Trial end date: 2015-10-01
• Target enrollment: 0
• Participant gender: All

Summary

This study aims to identify if clarithromycin (CLM) has potential as a widely available and inexpensive treatment for cachexia (the loss of muscle mass) in people with non-small cell lung cancer (NSCLC). Half the participants will receive clarithromycin and half will receive a placebo.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Nottingham
• Collaborator: Roy Castle Lung Cancer Foundation
• Treatments: Clarithromycin

Criteria

Inclusion Criteria:

• Adults with stage IV, pathologically confirmed, NSCLC not suitable for/declining/not tolerating 1st/2nd-line palliative chemotherapy, or following completion of 1st/2nd-line palliative chemotherapy

• A likely prognosis of ≥3 months.

• Cachexia on the basis of any of the following, weight loss >5% over past 6 months, or BMI <20kg/m2 and weight loss >2%, or appendicular skeletal muscle index determined by duel energy x-ray absorptiometry consistent with sarcopenia and weight loss >2%.

• Systemic inflammation on the basis of a C-reactive protein >10mg/L.

• Adequate renal function as defined by creatinine ≤132micromol/L and eGFR ≥30mL/min/1.73m2

• Adequate liver function as defined by the following parameters, bilirubin ≤25micromol/L, and AST and ALT ≤2 times upper limit of normal, unless liver metastases, in which case ≤5 times upper limit of normal

• Prepared to suspend, if necessary, the use of certain statins and/or substitute the use of domperidone for an alternative anti-emetic for the duration of the study

Exclusion Criteria:

• ECOG Performance Status 3 or 4

• Little or no food intake

• Weight loss >10% in 1 month or >20% in total

• Known hypersensitivity to clarithromycin

• Inability to accurately measure QT interval, e.g. atrial fibrillation

• QTc prolongation >450 milliseconds in a male, or 470 milliseconds in a female

• History of ventricular arrhythmia

• Severe cardiac insufficiency (NYHA class >2)

• Untreated hypokalaemia/hypomagnesaemia

• Active infection requiring antibiotics

• Current or recent (within last 4 weeks) history of Clostridium difficile, eating disorder, dysphagia, malabsorption or diarrhoea

• Untreated adrenal or thyroid diseases

• Brain metastases

• Use of corticosteroids/progestogens

• Use of chemotherapy, other immunosuppressive, or antiviral (e.g. hepatitis C, HIV) drugs within 4 weeks

• Drugs which are contra-indicated (except certain statins which can be temporarily suspended and domperidone which can be substituted for an alternative anti-emetic) or should be avoided in patients receiving clarithromycin, either because of the risk of a drug-drug interaction and/or prolonged QT

• Pregnancy

• Breast Feeding