MK2206 and Erlotinib Hydrochloride in Treating Patients With Advanced Non-Small Cell Lung Cancer Who Have Progressed After Previous Response to Erlotinib Hydrochloride Therapy
Adenosquamous Lung Carcinoma
Large Cell Lung Carcinoma
Recurrent Non-Small Cell Lung Carcinoma
Squamous Cell Lung Carcinoma
Drug: Akt Inhibitor MK2206
Drug: Erlotinib Hydrochloride
Other: Laboratory Biomarker Analysis
Other: Pharmacological Study
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Trial of the Akt Inhibitor MK-2206 Plus Erlotinib (OSI-774) in Patients With Advanced Non-small Cell Lung Cancer Who Have Progressed After Previous Response (Including Stable Disease) With Erlotinib Therapy|
- Disease-control rate (DCR: response rate + stable disease) in patients with EGFR wild-type tumor (stratum 2) [ Time Frame: At 12 weeks ] [ Designated as safety issue: No ]
- Objective response of patients with EGFR mutation as defined by Response Evaluation Criteria in Solid Tumors (stratum 1) [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]Summarized with Kaplan-Meier plots.
- Progression-free survival rate [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]Summarized with Kaplan-Meier plots.
- Toxicity of Akt inhibitor MK2206 plus erlotinib hydrochloride, graded according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 [ Time Frame: Up to 2 years ] [ Designated as safety issue: Yes ]The type, severity, time of onset, duration, and outcome of toxicities will be summarized.
|Study Start Date:||February 2011|
|Study Completion Date:||August 2015|
|Primary Completion Date:||August 2015 (Final data collection date for primary outcome measure)|
Experimental: Treatment (Akt inhibitor MK2206, erlotinib hydrochloride)
Patients receive Akt inhibitor MK2206 PO QOD of a 28-day course, and erlotinib hydrochloride PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Drug: Akt Inhibitor MK2206
Other Name: MK2206Drug: Erlotinib Hydrochloride
Other Names:Other: Laboratory Biomarker Analysis
Correlative studiesOther: Pharmacological Study
I. To evaluate the efficacy (with the primary endpoint of disease control at 12 weeks) and tolerability of the combination of MK2206 plus erlotinib (erlotinib hydrochloride) in previously erlotinib-treated patients with recurrent or progressive advanced non-small cell lung cancer (NSCLC) whose tumors are either epidermal growth factor receptor (EGFR) mutated or EGFR wild-type.
I. To determine progression-free survival of previously erlotinib-treated patients with NSCLC who are treated with MK2206 plus erlotinib. II. To determine the overall survival of previously erlotinib-treated patients with NSCLC who are treated with MK2206 plus erlotinib.
III. To assess the toxicity experienced by previously erlotinib-treated patients with NSCLC treated with MK2206 plus erlotinib. IV. To perform correlative analysis of tumor biomarkers to assess, in a preliminary manner, the association between tumor mutations and/or abnormalities and clinical outcome of previously erlotinib-treated patients with NSCLC treated with MK2206 plus erlotinib.
Patients receive Akt inhibitor MK2206 orally (PO) every other day (QOD) of a 28-day course, and erlotinib hydrochloride PO once daily (QD) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study therapy, patients are followed up every 12 weeks for one year and then annually thereafter.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01294306
|United States, California|
|Tower Cancer Research Foundation|
|Beverly Hills, California, United States, 90211-1850|
|City of Hope Comprehensive Cancer Center|
|Duarte, California, United States, 91010|
|USC / Norris Comprehensive Cancer Center|
|Los Angeles, California, United States, 90033|
|University of California Davis Comprehensive Cancer Center|
|Sacramento, California, United States, 95817|
|City of Hope South Pasadena|
|South Pasadena, California, United States, 91030|
|United States, Illinois|
|University of Chicago Comprehensive Cancer Center|
|Chicago, Illinois, United States, 60637|
|United States, Pennsylvania|
|University of Pittsburgh Cancer Institute (UPCI)|
|Pittsburgh, Pennsylvania, United States, 15232|
|Principal Investigator:||Primo Lara||Beckman Research Institute|