COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Romidepsin and Erlotinib Hydrochloride in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01302808
Recruitment Status : Completed
First Posted : February 24, 2011
Last Update Posted : June 1, 2015
Celgene Corporation
Genentech, Inc.
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center

Brief Summary:

RATIONALE: Romidepsin and erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This phase I/II trial is studying the side effects and best dose of romidepsin when given together with erlotinib hydrochloride and to see how well they work in treating patients with stage III or stage IV non-small cell lung cancer.

Condition or disease Intervention/treatment Phase
Lung Cancer Metastatic Cancer Drug: erlotinib hydrochloride Drug: romidepsin Other: laboratory biomarker analysis Other: pharmacological study Phase 1 Phase 2

Detailed Description:



  • To characterize the toxicity and determine the maximum-tolerated dose (MTD) of erlotinib hydrochloride plus romidepsin. (Phase I)
  • To obtain preliminary data regarding efficacy, including response rate and progression-free survival. (Phase II)


  • To characterize the pharmacokinetic profile of romidepsin in combination with erlotinib hydrochloride.
  • To evaluate the impact of erlotinib hydrochloride on the biologic activity of romidepsin by analyzing peripheral blood mononuclear cell (PBMC) histone acetylation status and histone acetylase activity. (Exploratory)
  • To evaluate the effect of romidepsin and erlotinib hydrochloride on components of the EGFR-signaling pathway in skin biopsies, particularly downstream mediators such as MAPK. (Exploratory)

OUTLINE: This is a dose-escalation study of romidepsin followed by a phase II study.

Patients receive romidepsin IV on days 1, 8, and 15 and erlotinib hydrochloride orally (PO) once daily beginning on day 3 of course 1 and on days 1-28 of all subsequent courses. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Patients undergo blood sample collection at baseline and periodically during study for pharmacokinetic studies. Additional samples of peripheral blood mononuclear cells and skin biopsies may be also collected for correlative studies.

After completion of study therapy, patients are followed up for 30 days.

PROJECTED ACCRUAL: A total of 39 patients (15 patients for phase I and 24 patients for phase II) will be accrued for this study.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II Study of Erlotinib and Romidepsin in Advanced Non-Small Cell Lung Cancer
Study Start Date : September 2009
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Primary Outcome Measures :
  1. Toxicity of erlotinib hydrochloride plus romidepsin
  2. Maximum-tolerated dose (MTD) of erlotinib hydrochloride plus romidepsin

Secondary Outcome Measures :
  1. Time to response, progression-free survival, and overall survival
  2. Pharmacokinetic profile of romidepsin in combination with erlotinib hydrochloride

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed locally advanced or metastatic (stage IIIB pleural effusion or stage IV) non-small cell lung cancer (NSCLC), including the following cell types:

    • Squamous cell carcinoma
    • Adenocarcinoma
    • Adenosquamous carcinoma
    • Large cell carcinoma
    • Large cell neuroendocrine
    • Carcinoma not otherwise specified
  • Measurable disease as defined by RECIST
  • Clinically stable brain metastases are permitted


  • ECOG performance status 0-1
  • Serum potassium ≥ 3.8 mmol/L and magnesium ≥ 2.0 mg/dL

    • Electrolyte abnormalities may be corrected with supplementation
  • Hemoglobin ≥ 10 g/dL (transfusions and/or erythropoietin-stimulating agents are permitted)
  • ANC ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Total bilirubin < 1.5 times upper limit of normal (ULN)
  • AST and ALT < 2.0 times ULN (< 3 times ULN in the presence of demonstrable liver metastases)
  • Serum creatinine < 2.0 times ULN
  • Not pregnant or nursing
  • Negative urine or serum pregnancy test
  • Women of childbearing potential and men must use an effective barrier method of contraception (e.g., an intrauterine contraception device [IUCD], double-barrier method using condoms, or a diaphragm plus spermicide) during the treatment period and for at least 1 month thereafter
  • No known cardiac abnormalities, including any of the following:

    • Congenital long QT syndrome
    • QTc interval > 480 msec
    • Myocardial infarction within 12 months prior to study entry
    • Other significant electrocardiogram (ECG) abnormalities, including type II second- or third-degree atrio-ventricular (AV) block, or bradycardia (ventricular rate < 50 beats/min)
    • History of coronary artery disease (CAD) (e.g., angina Canadian class II-IV)

      • For any patients in whom there is doubt, a stress-imaging study should be performed and if abnormal, an angiography should also be performed to define whether or not CAD is present
    • An ECG recorded at screening showing significant ST depression (ST depression of ≥ 2 mm, measured from isoelectric line to the ST segment at a point 60 msec from the end of the QRS complex)
    • NYHA class II to IV congestive heart failure (CHF), and/or ejection fraction (EF) < 40% by MUGA scan or < 50% by ECG and/or MRI
    • Known history of sustained ventricular tachycardia (VT), ventricular fibrillation (VF), Torsades de Pointes, or cardiac arrest, unless currently addressed with an automatic implantable cardiac defibrillator (AICD)
    • Hypertrophic cardiomyopathy or restrictive cardiomyopathy from prior treatment or other causes
    • Uncontrolled hypertension defined as blood pressure ≥ 160/95 mm Hg
    • Any cardiac arrhythmia requiring anti-arrhythmia medication
  • No clinically significant active systemic, pulmonary, or pericardial infection, including known HIV infection and hepatitis B or C
  • No significant medical or psychiatric condition that might prevent the patient from complying with all study procedures


  • At least 3 weeks since prior erlotinib hydrochloride (phase I)
  • At least 3 weeks since prior anti-cancer therapy or, at the discretion of the investigator, may be treatment-naive (phase I)
  • At least 1 and no more than 2 prior chemotherapy regimens for advanced NSCLC (phase II)
  • At least 3 weeks since prior chemotherapy for NSCLC
  • At least 2 weeks since prior major surgery or radiation therapy
  • No prior erlotinib hydrochloride (phase II)
  • No prior romidepsin
  • No other concurrent anti-cancer therapy
  • No prior or concurrent investigational agent within 4 weeks prior to study entry
  • No concurrent drugs that may cause a prolongation of the QTc interval
  • No concurrent CYP3A4 inhibitors
  • No concurrent warfarin

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01302808

Layout table for location information
United States, Texas
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
Dallas, Texas, United States, 75390
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Celgene Corporation
Genentech, Inc.
Layout table for investigator information
Principal Investigator: David E. Gerber, MD Simmons Cancer Center

Layout table for additonal information
Responsible Party: University of Texas Southwestern Medical Center Identifier: NCT01302808    
Other Study ID Numbers: SCCC-12508
CDR0000653093 ( Registry Identifier: PDQ (Physician Data Query) )
NCI-2011-01035 ( Registry Identifier: CTRP (Clinical Trials Reporting System) )
First Posted: February 24, 2011    Key Record Dates
Last Update Posted: June 1, 2015
Last Verified: May 2015
Keywords provided by University of Texas Southwestern Medical Center:
recurrent non-small cell lung cancer
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer
malignant pleural effusion
adenocarcinoma of the lung
adenosquamous cell lung cancer
bronchoalveolar cell lung cancer
large cell lung cancer
squamous cell lung cancer
Additional relevant MeSH terms:
Layout table for MeSH terms
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Erlotinib Hydrochloride
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antibiotics, Antineoplastic