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

Phase 1

Withdrawn

• Conditions: Lung Cancer
• Interventions: Drug: cisplatin; Drug: etoposide phosphate; Drug: panobinostat; Other: laboratory biomarker analysis; Other: pharmacological study

• Registration Number: NCT01160731
• Lead Sponsor: Cancer Trials Ireland

Brief Summary

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.

Detailed Description

OBJECTIVES:

Primary

* 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.

Secondary

* 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.

Study Timeline

• Study Start: 2009-11
• Study First Submitted: 2010-07-09
• Study First Submitted QC: 2010-07-09
• Study First Posted: 2010-07-12
• Primary Completion: 2010-10
• Status Verified: 2012-10
• Last Update Submitted: 2014-12-30
• Last Update Posted: 2014-12-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cisplatin, Etoposide & Panobinostat	laboratory biomarker analysis	-
Cisplatin, Etoposide & Panobinostat	cisplatin	-
Cisplatin, Etoposide & Panobinostat	etoposide phosphate	-
Cisplatin, Etoposide & Panobinostat	panobinostat	-
Cisplatin, Etoposide & Panobinostat	pharmacological study	-

Primary Outcome Measures

Name	Time	Method
Response rates and toxicity at MTD and RD
Objective response rate according to RECIST criteria
Maximum-tolerated dose (MTD) and recommended dose (RD)

Secondary Outcome Measures

Name	Time	Method
Time to progression according to RECIST criteria
Duration of response or disease stabilization according to RECIST criteria
Overall survival according to RECIST criteria
Effect of the combination regimen on drug pharmacokinetics
Adverse events
Quality of life evaluated by EQ-5D (Euro QoL)