A Phase II Study of the mTOR Inhibitor RAD001 in Previously Treated Patients With Unresectable or Metastatic Adenocarcinoma of the Esophagus and Stomach
- 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.
- 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.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall disease-control rate (complete response, partial response, or stable disease)
Zev A. Wainberg, MD
Jonsson Comprehensive Cancer Center
United States: Food and Drug Administration
|Comprehensive Cancer Centers of Nevada||Las Vegas, Nevada 89109|
|Jonsson Comprehensive Cancer Center at UCLA||Los Angeles, California 90095-1781|
|Wilshire Oncology Medical Group, Inc.||Rancho Cucamonga, California 91730|
|Comprehensive Blood and Cancer Center||Bakersfield, California 93309|
|Pacific Shores Medical Group||Long Beach, California 90813|
|Sansum Medical Clinic||Santa Barbara, California 93105|
|North Valley Hematology/Oncology Medical Group||Northridge, California 91328|
|Santa Barbara Hematology Oncology Medical Group, Inc.||Santa Barbara, California 93105|
|Cancer Care Associates Medical Group, Inc.||Torrance, California 90505|
|Northwest Georgia Oncology Centers, P.C.||Marietta, Georgia 30060|
|Antelope Valley Cancer Center||Lancaster, California 93534|
|Central Hematology Oncology Medical Group, Inc.||Alhambra, California 91801|
|Suburban Hematology-Oncology Associates, P.A.||Lawrenceville, Georgia 30045|
|Central Coast Medical Oncology Corporation||Santa Maria, California 93454|
|Trivalley Oncology Hematology||Westlake Village, California 91361|
|Translational Oncology Research International (TORI) Network||Los Angeles, California 90095|
|St. Jude Heritage Medical Group at Virginia K. Crosson Cancer Center||Fullerton, California 92835|
|TORI REDONDO BEACH (Cancer Care Associates Medical Group, Inc.)||Redondo Beach, California 90277|