Romidepsin and Erlotinib Hydrochloride in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer
|ClinicalTrials.gov Identifier: NCT01302808|
Recruitment Status : Completed
First Posted : February 24, 2011
Last Update Posted : June 1, 2015
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|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
U.S. FDA Resources
- Toxicity of erlotinib hydrochloride plus romidepsin
- Maximum-tolerated dose (MTD) of erlotinib hydrochloride plus romidepsin
- Time to response, progression-free survival, and overall survival
- Pharmacokinetic profile of romidepsin in combination with erlotinib hydrochloride
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01302808
|United States, Texas|
|Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas|
|Dallas, Texas, United States, 75390|
|Principal Investigator:||David E. Gerber, MD||Simmons Cancer Center|