Gastric Cancer Clinical Trial
Official title:
A Phase II Study of the mTOR Inhibitor RAD001 in Previously Treated Patients With Unresectable or Metastatic Adenocarcinoma of the Esophagus and Stomach
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.
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