Romidepsin and Erlotinib Hydrochloride in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer
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.
Drug: erlotinib hydrochloride
Other: laboratory biomarker analysis
Other: pharmacological study
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I/II Study of Erlotinib and Romidepsin in Advanced Non-Small Cell Lung Cancer|
- Toxicity of erlotinib hydrochloride plus romidepsin [ Designated as safety issue: Yes ]
- Maximum-tolerated dose (MTD) of erlotinib hydrochloride plus romidepsin [ Designated as safety issue: Yes ]
- Time to response, progression-free survival, and overall survival [ Designated as safety issue: No ]
- Pharmacokinetic profile of romidepsin in combination with erlotinib hydrochloride [ Designated as safety issue: No ]
|Study Start Date:||September 2009|
|Study Completion Date:||December 2014|
|Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: 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|