This phase II clinical trial studies how well Akt inhibitor MK2206 works in treating patients with advanced gastric or gastroesophageal junction cancer. Akt inhibitor MK2206 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PRIMARY OBJECTIVES: I. To estimate the overall survival (OS) for patients with advanced gastric and gastroesophageal junction (GEJ) adenocarcinoma treated with MK-2206 (Akt inhibitor MK2206). SECONDARY OBJECTIVES: I. To estimate the progression free survival (PFS) in this patient population. II. To estimate the response rate (confirmed and unconfirmed complete response \[CR\] and partial response \[PR\] by Response Evaluation Criteria In Solid Tumors \[RECIST\] 1.1) in this patient population. III. To assess the frequency and severity of toxicity associated with this regimen. OUTLINE (CLOSED TO ACCRUAL 05/01/13): Patients receive Akt inhibitor MK2206 orally (PO) every other day 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 3 months for 2 years.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
75
Given PO
Providence Hospital
Mobile, Alabama, United States
Fairbanks Memorial Hospital
Fairbanks, Alaska, United States
The University of Arizona Cancer Center-Orange Grove Campus
Tucson, Arizona, United States
The University of Arizona Cancer Center-North Campus
Tucson, Arizona, United States
The University of Arizona Medical Center-University Campus
Tucson, Arizona, United States
Overall Survival (OS)
Overall survival is calculated from date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.
Time frame: Up to 2 years
Progression Free Survival (PFS)
PFS is measured from date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and without report of progression are censored at date of last contact. Progression is one or more of the following: 20% increase in the sum of appropriate diameters of target measurable lesions over smallest sum observed (over baseline if no decrease during therapy), as well as an absolute increase of at least 0.5 cm; unequivocal progression of non-measurable disease in the opinion of the treating physician; appearance of any new lesion/site; death due to disease without prior documentation of progression and without symptomatic deterioration. Symptomatic deterioration is global deterioration of health status requiring discontinuation of treatment without objective evidence of progression.
Time frame: Up to 2 years
Response Rate (Complete and Partial, Confirmed and Unconfirmed)
Complete response (CR) is complete disappearance of all target and non-target lesions, no new lesions, and no disease related symptoms. Any lymph nodes must have reduction in short axis to \< 1.0 cm. Partial response (PR) is \>= 30% decrease under baseline of the sum of appropriate diameters of all target measurable lesions, no unequivocal progression of non-measurable disease, and no new lesions. Confirmed CR is two or more statuses of CR a minimum of four weeks apart documented before progression or symptomatic deterioration. Confirmed PR is two or more statuses of PR or better a minimum of four weeks apart documented before progression or symptomatic deterioration, but not qualifying as CR. Unconfirmed CR is one status of CR documented before progression or symptomatic deterioration but not qualifying as CR or PR. Unconfirmed PR is one status of PR documented before progression or symptomatic deterioration but not qualifying as CR, PR or unconfirmed CR.
Time frame: Up to 2 years
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Any CTCAE 4.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which were possibly, probably or definitely related to protocol treatment are included.
Time frame: Up to 2 years
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Fowler Family Center for Cancer Care
Jonesboro, Arkansas, United States
NEA Baptist Memorial Hospital
Jonesboro, Arkansas, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California, United States
...and 177 more locations