RATIONALE: Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. PURPOSE: This phase II trial is studying how well everolimus works in treating patients with previously treated unresectable or metastatic esophageal cancer or stomach cancer.
OBJECTIVES: Primary * To determine the overall disease-control rate (complete response, partial response, or stable disease) in patients with previously treated unresectable or metastatic adenocarcinoma of the upper gastrointestinal tract treated with everolimus. Secondary * To determine the safety and toxicity of everolimus in these patients. * To determine the efficacy of everolimus, in terms of time to response, duration of response, time to tumor progression, progression-free survival, and overall survival, in these patients. * To explore potential correlations between clinical outcome and biomarkers of interest, including S6 protein overexpression and/or other mTOR-related proteins in blood and tumor biopsy samples from these patients. OUTLINE: This is a multicenter study. Patients receive oral everolimus once daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. Blood, serum, and tumor tissue samples are collected for biomarker analysis. After completion of study treatment, patients are followed up every 3 months for 1 year and then every 6 months thereafter.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
49
Central Hematology Oncology Medical Group, Inc.
Alhambra, California, United States
Overall Disease-control Rate in Patients With Previously Treated Unresectable or Metastatic Adenocarcinoma of the Upper Gastrointestinal Tract Treated With Everolimus.
Disease control rate (DCR), defined as complete response (CR) + partial response (PR) + stable disease (SD) according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria.
Time frame: Radiologic disease assessment was performed every 8 weeks (14 days = 1 cycle) treatment discontinuation.
Overall Survival
Overall Survival (OS), defined as the time from date of initial treatment to date of death. Survival function was estimated using the Kaplan-Meier method.
Time frame: 2.5 year
Efficacy in Terms of Progression Free Response
Progression-free survival (PFS), was defined as the time from the date of initial treatment to first objective documentation of disease progression, or death. Estimated using the Kaplan-Meier method. Complete response (CR) + partial response (PR) + stable disease (SD) were determined according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Radiologic disease assessments were utilized.
Time frame: evry 3 months in year 1, every 6 months after that
Observed Biomarkers
Potential correlations between clinical outcome and biomarkers of interest, including S6 protein overexpression and/or other mTOR-related proteins in tumor tissue samples from these patients.
Time frame: 30 months
Biomarker Correlations: Progression Free Survival
Potential correlations between progression free survival and S6 protein and mTOR-related proteins in tumor tissue samples from these patients.
Time frame: 30 months
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Biomarker Correlations: Time to Progression
Potential correlations between time to progression and S6 protein and mTOR-related proteins in tumor tissue samples from these patients.
Time frame: 30 months