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

• Status: Completed
• Trial end date: 0000-00-00
• Target enrollment: 18
• Participant gender: Both

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Texas Southwestern Medical Center
• Collaborators: Celgene Corporation; Genentech, Inc.
• Treatments: Erlotinib Hydrochloride; Romidepsin
• Last Updated: 2015-05-29

Criteria

DISEASE CHARACTERISTICS:

• 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

PATIENT CHARACTERISTICS:

• 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

PRIOR CONCURRENT THERAPY:

• 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