Spots Global Cancer Trial Database for Everolimus in Treating Patients With Previously Treated Unresectable or Metastatic Esophageal Cancer or Stomach Cancer
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Trial Identification
Brief Title: Everolimus in Treating Patients With Previously Treated Unresectable or Metastatic Esophageal Cancer or Stomach Cancer
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
Study ID: NCT00985192
Study Description
Brief Summary: 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.
Detailed Description: 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Central Hematology Oncology Medical Group, Inc., Alhambra, California, United States
Comprehensive Blood and Cancer Center, Bakersfield, California, United States
St. Jude Heritage Medical Group at Virginia K. Crosson Cancer Center, Fullerton, California, United States
Antelope Valley Cancer Center, Lancaster, California, United States
Pacific Shores Medical Group, Long Beach, California, United States
Jonsson Comprehensive Cancer Center at UCLA, Los Angeles, California, United States
Translational Oncology Research International (TORI) Network, Los Angeles, California, United States
North Valley Hematology/Oncology Medical Group, Northridge, California, United States
Wilshire Oncology Medical Group, Inc., Pomona, California, United States
Cancer Care Associates Medical Group, Inc., Redondo Beach, California, United States
TORI REDONDO BEACH (Cancer Care Associates Medical Group, Inc.), Redondo Beach, California, United States
Sansum Medical Clinic, Santa Barbara, California, United States
Santa Barbara Hematology Oncology Medical Group, Inc., Santa Barbara, California, United States
Central Coast Medical Oncology Corporation, Santa Maria, California, United States
Trivalley Oncology Hematology, Westlake Village, California, United States
Suburban Hematology-Oncology Associates, P.A., Lawrenceville, Georgia, United States
Northwest Georgia Oncology Centers, P.C., Marietta, Georgia, United States
Comprehensive Cancer Centers of Nevada, Las Vegas, Nevada, United States
Contact Details
Name: Zev A. Wainberg, MD
Affiliation: Jonsson Comprehensive Cancer Center
Role: PRINCIPAL_INVESTIGATOR
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