Panobinostat, Etoposide, and Cisplatin as First-Line Therapy in Treating Patients With Extensive-Stage Small Cell Lung Cancer

This is an interventional treatment trial for Lung Cancer focused on measuring extensive stage small cell lung cancer Read More

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed small cell lung cancer

  • Extensive-stage disease
• Measurable disease according to RECIST criteria
• No symptomatic brain metastasis or meningeal tumors

PATIENT CHARACTERISTICS:

• ECOG performance status 0-1
• Life expectancy ≥ 6 months
• Absolute neutrophil count > 1,500/mm^3
• Platelet count ≥ 100,000/mm^3
• Hemoglobin ≥ 10.0 g/dL
• Serum creatinine ≤ 1.5 x upper limit of normal (ULN) OR 24-hour creatinine clearance ≥ to 60 mL/min
• Magnesium, potassium, and phosphorus ≥ the lower limit of normal OR correctable with supplements prior to study treatment
• AST/ALT ≤ 2.5 x ULN (≤ 5.0 x ULN if hepatic metastases are present)
• Serum bilirubin ≤ 1.5 x ULN
• Alkaline phosphatase ≤ 2.5 x ULN OR liver fraction ≤ 2.5 x ULN
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective double contraception (at least 1 barrier method) during and for at least 30 days after completion of study treatment

• No impaired cardiac function, including any one of the following:

  • LVEF < 45% as determined by ECHO
  • Complete left bundle branch block, obligate use of a cardiac pacemaker, congenital long QT syndrome, history or presence of atrial or ventricular tachyarrhythmias, clinically significant resting bradycardia (< 50 beats per minute), QTcF > 480 msec on screening ECG, or right bundle branch block and left anterior hemiblock (bifascicular block)
  • Uncontrolled angina pectoris or acute myocardial infarction within the past 3 months
  • Other clinically significant heart disease (e.g., congestive heart failure, uncontrolled hypertension, history of labile hypertension, or history of poor compliance with an antihypertensive regimen)
• No history of HIV or AIDS-related illness
• No acute or chronic liver or renal disease

• No other concurrent severe and/or uncontrolled medical conditions that could cause unacceptable safety risks or compromise compliance with the protocol, including any of the following:

  • Uncontrolled diabetes
  • Chronic obstructive or chronic restrictive pulmonary disease
  • Active or uncontrolled infection
• No known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to panobinostat, cisplatin, or etoposide
• No hearing impairment that would be a contraindication to the use of cisplatin

PRIOR CONCURRENT THERAPY:

• No prior chemotherapy
• No investigational drug or experimental medications or treatments within the past 30 days or 5 half-lives, whichever is longer