A Randomized, Double-Blind, Pilot Study Comparing the Safety and Efficacy of Betamarc Plus Chemotherapy to Chemotherapy Alone in the Prevention and Treatment of CACS in Patients With Advanced NSCLC
- Newly diagnosed Stage IIIB or IV non-resectable NSCLC. Recurrent disease after
resection for earlier stage disease is acceptable as long as patients are at least 6
months from surgery.
- Treatment plan includes a platinum-based doublet chemotherapy.
- ECOG 0, 1 or 2.
- Self-reported loss of body weight or anorexia.
- Serum C-reactive protein ≥5 mg/L.
- Life expectancy of at least 6 months.
- Adequate bone marrow, liver and renal function.
- Normal serum potassium.
- Ability to comply with the study requirements and give written informed consent.
- Known physical or functional obstruction of the gastrointestinal tract,
malabsorption, intractable vomiting, uncontrollable diarrhea, concurrently receiving
tube feeding or parenteral nutrition, or unable to swallow investigational drug
- Concomitant therapy with an appetite stimulant.
- History of poorly controlled hypertension or congestive heart failure.
- Any implanted devices that could interfere with DXA scanning.
- Prolongation of QT interval.
- History of additional risk factors for torsades de pointe.
- Concomitant therapy with beta-adrenergic receptor antagonists (beta-blockers) or
- Females who are breast feeding, pregnant or of child-bearing potential who are not
using adequate birth control.
- Any second malignancy which might confound the interpretation of safety or efficacy
- Any condition which increases the patient's risk for participating in the study.