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

This study is currently recruiting participants.
Verified on July 2010 by National Cancer Institute (NCI)

First Received on July 9, 2010.  
No Changes Posted
This Clinical Trial Sponsored By: All Ireland Cooperative Oncology Research Group
Information provided by: National Cancer Institute (NCI) Identifier: NCT01160731

Purpose for Clinical Trial

RATIONALE: Panobinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as etoposide and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving panobinostat together with etoposide and cisplatin may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of panobinostat when given together with etoposide and cisplatin as first-line therapy in treating patients with extensive-stage small cell lung cancer.

Condition Study Intervention Clinical Trial Phase
Lung Cancer Drug: cisplatin
Drug: etoposide phosphate
Drug: panobinostat
Other: laboratory biomarker analysis
Other: pharmacological study
Phase I

Study Type: Study Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Dose Finding Study of the Pan-DAC Inhibitor Panobinostat (LBH589) in Combination With Etoposide and Cisplatin in the First Line Treatment of Extensive-Stage Small Cell Lung Cancer – An ICORG In-House Study

Resource links provided by NLM:

MedlinePlus related topics:
Lung Cancer
Drug Information available for:
Etoposide phosphate

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures For Clinical Trial:

  • Maximum-tolerated dose (MTD) and recommended dose (RD) [ Designated as safety issue: No ]
  • Response rates and toxicity at MTD and RD [ Designated as safety issue: Yes ]
  • Objective response rate according to RECIST criteria [ Designated as safety issue: No ]

Secondary Outcome Measures For Clinical Trial:

  • Time to progression according to RECIST criteria [ Designated as safety issue: No ]
  • Duration of response or disease stabilization according to RECIST criteria [ Designated as safety issue: No ]
  • Overall survival according to RECIST criteria [ Designated as safety issue: No ]
  • Effect of the combination regimen on drug pharmacokinetics [ Designated as safety issue: No ]
  • Adverse events [ Designated as safety issue: Yes ]
  • Quality of life evaluated by EQ-5D (Euro QoL) [ Designated as safety issue: Yes ]

Estimated Enrollment: 24
Study Start Date: November 2009
Estimated Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)

Detailed Description:



  • To determine the maximum-tolerated dose, the recommended dose, and the activity of panobinostat when given in combination with etoposide and cisplatin to patients with extensive-stage small cell lung cancer.


  • To estimate the time-to-progression, the duration of response, and disease stabilization in these patients.
  • To estimate the overall survival of these patients.
  • To determine the pharmacokinetic profile of panobinostat in combination with etoposide and cisplatin.
  • To assess the overall safety profile of panobinostat in these patients.
  • To determine the adverse events in these patients treated with this regimen.
  • To assess the quality of life of these patients.

OUTLINE: This is a multicenter, dose-escalation study of panobinostat.

Patients receive chemotherapy comprising cisplatin IV on day 1, etoposide IV on days 1-3, and panobinostat IV over 30 minutes on days 1 and 8. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline and then periodically during study treatment and follow up, using questionnaire EQ-5D (Euro QoL).

Blood samples may be collected at baseline and periodically during and after study treatment for pharmacokinetic assessment and biomarker translational studies.

After completion of study treatment, patients are followed up at 4 weeks and then every 3 months.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No


  • Histologically or cytologically confirmed small cell lung cancer

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


  • 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
    • Chr

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