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

NCT01160731 | Withdrawn Phase 1

• 4 other identifiers: 07-09 ICORGICORG-07-09EUDRACT-2008-003634-21EU-21047
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Lung Cancer

Keywords

extensive stage small cell lung cancer

Outcome Measures

Primary Outcomes (3)

• Maximum-tolerated dose (MTD) and recommended dose (RD)

• Response rates and toxicity at MTD and RD

• Objective response rate according to RECIST criteria

Secondary Outcomes (6)

• 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

Study Arms (1)

Cisplatin, Etoposide & Panobinostat

EXPERIMENTAL

Drug: cisplatin; Drug: etoposide phosphate; Drug: panobinostat; Other: laboratory biomarker analysis; Other: pharmacological study

Interventions

cisplatin DRUG

Cisplatin, Etoposide & Panobinostat

etoposide phosphate DRUG

Cisplatin, Etoposide & Panobinostat

panobinostat DRUG

Cisplatin, Etoposide & Panobinostat

laboratory biomarker analysis OTHER

Cisplatin, Etoposide & Panobinostat

pharmacological study OTHER

Cisplatin, Etoposide & Panobinostat

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Cancer Trials Ireland: lead

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Cisplatin; etoposide phosphate; Panobinostat

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Hydroxamic Acids; Hydroxylamines; Amines; Organic Chemicals; Hydroxy Acids; Carboxylic Acids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Paul Donnellan

  Galway University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2010
• First Posted: July 12, 2010
• Study Start: November 1, 2009
• Primary Completion: October 1, 2010
• Last Updated: December 31, 2014

Record last verified: 2012-10