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Everolimus in Treating Patients With Previously Treated Unresectable or Metastatic Esophageal Cancer or Stomach Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00985192
First Posted: September 28, 2009
Last Update Posted: March 29, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Cancer Institute (NCI)
University of California, Los Angeles
Information provided by (Responsible Party):
Translational Oncology Research International
  Purpose

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.


Condition Intervention Phase
Esophageal Cancer Gastric Cancer Drug: everolimus Other: laboratory biomarker analysis Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Translational Oncology Research International:

Primary Outcome Measures:
  • Overall Disease-control Rate in Patients With Previously Treated Unresectable or Metastatic Adenocarcinoma of the Upper Gastrointestinal Tract Treated With Everolimus. [ Time Frame: Radiologic disease assessment was performed every 8 weeks (14 days = 1 cycle) treatment discontinuation. ]
    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.


Secondary Outcome Measures:
  • Overall Survival [ Time Frame: 2.5 year ]
    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.

  • Efficacy in Terms of Progression Free Response [ Time Frame: evry 3 months in year 1, every 6 months after that ]
    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.

  • Observed Biomarkers [ Time Frame: 30 months ]
    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.

  • Biomarker Correlations: Progression Free Survival [ Time Frame: 30 months ]
    Potential correlations between progression free survival and S6 protein and mTOR-related proteins in tumor tissue samples from these patients.

  • Biomarker Correlations: Time to Progression [ Time Frame: 30 months ]
    Potential correlations between time to progression and S6 protein and mTOR-related proteins in tumor tissue samples from these patients.


Enrollment: 49
Study Start Date: September 2009
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Everolimus
Patients receive oral everolimus once daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity
Drug: everolimus Other: laboratory biomarker analysis

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Diagnosis of adenocarcinoma of the upper gastrointestinal tract
  • Metastatic or unresectable disease
  • Received 1-2 prior chemotherapy or biological therapy regimens for unresectable or metastatic disease
  • Measurable disease in ≥ 1 dimension by CT scan or MRI
  • Patients whose only measurable lesion is a metastatic lymph node are eligible provided they have permission from the principal investigator
  • ECOG performance status 0-1
  • Life expectancy > 3 months
  • ANC ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 9 g/dL
  • Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • AST and ALT ≤ 2.5 times ULN (≤ 5.0 times ULN if there is liver metastasis)
  • Creatinine clearance > 60 mL/min
  • Fasting serum cholesterol < 300 mg/dL or < 7.75 mmol/L*
  • Fasting triglycerides < 2.5 times ULN*
  • INR ≤ 3.5 (for patients on warfarin)
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for ≥ 4 months after completion of study treatment (oral, implantable, or injectable contraceptives are not considered effective contraception for this study)
  • More than 30 days since prior chemotherapy, surgery, radiotherapy, or investigational agents

Exclusion Criteria:

  • uncontrolled diabetes mellitus, defined as fasting serum glucose > 1.5 times ULN
  • severely impaired lung function
  • known HV infection
  • active, bleeding diathesis
  • unstable angina pectoris, symptomatic congestive heart failure, or myocardial infarction within the past 6 months
  • serious uncontrolled cardiac arrhythmia
  • active or uncontrolled infection requiring parenteral antimicrobials
  • known liver disease (e.g., cirrhosis, chronic active hepatitis, or chronic persistent hepatitis)
  • inability to swallow, impaired gastrointestinal (GI) function, or GI disease (e.g., ulcerative colitis, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection) that would significantly alter the absorption of study drugs or preclude the use of oral medications
  • other malignancy within the past 5 years except for nonmelanoma skin cancer or cervical carcinoma in situ
  • known hypersensitivity to everolimus, sirolimus, or temsirolimus or to their excipients
  • other medical conditions that, in the opinion of the investigator, would preclude study participation
  • prior mTOR inhibitors (e.g., rapamycin, CCI-779)
  • concurrent chronic treatment with steroids or another immunosuppressive agent
  • concurrent prophylactic use of hematopoietic growth factors
  • concurrent anticancer agents or therapy (including radiotherapy)
  • other concurrent experimental agents
  • concurrent strong inhibitors or inducers of the isoenzyme CYP3A4
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00985192


Locations
United States, California
Central Hematology Oncology Medical Group, Inc.
Alhambra, California, United States, 91801
Comprehensive Blood and Cancer Center
Bakersfield, California, United States, 93309
St. Jude Heritage Medical Group at Virginia K. Crosson Cancer Center
Fullerton, California, United States, 92835
Antelope Valley Cancer Center
Lancaster, California, United States, 93534
Pacific Shores Medical Group
Long Beach, California, United States, 90813
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States, 90095-1781
Translational Oncology Research International (TORI) Network
Los Angeles, California, United States, 90095
North Valley Hematology/Oncology Medical Group
Northridge, California, United States, 91328
Wilshire Oncology Medical Group, Inc.
Pomona, California, United States, 91767
Cancer Care Associates Medical Group, Inc.
Redondo Beach, California, United States, 90277
TORI REDONDO BEACH (Cancer Care Associates Medical Group, Inc.)
Redondo Beach, California, United States, 90277
Sansum Medical Clinic
Santa Barbara, California, United States, 93105
Santa Barbara Hematology Oncology Medical Group, Inc.
Santa Barbara, California, United States, 93105
Central Coast Medical Oncology Corporation
Santa Maria, California, United States, 93454
Trivalley Oncology Hematology
Westlake village, California, United States, 91361
United States, Georgia
Suburban Hematology-Oncology Associates, P.A.
Lawrenceville, Georgia, United States, 30045
Northwest Georgia Oncology Centers, P.C.
Marietta, Georgia, United States, 30060
United States, Nevada
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States, 89109
Sponsors and Collaborators
Translational Oncology Research International
National Cancer Institute (NCI)
University of California, Los Angeles
Investigators
Principal Investigator: Zev A. Wainberg, MD Jonsson Comprehensive Cancer Center
  More Information

Responsible Party: Translational Oncology Research International
ClinicalTrials.gov Identifier: NCT00985192     History of Changes
Other Study ID Numbers: CDR0000655574
P30CA016042 ( U.S. NIH Grant/Contract )
UCLA-TRIO-TORI-GI-06
IRB# 09-07-061-01
NOVARTIS-UCLA-TRIO-TORI-GI-06
First Submitted: September 25, 2009
First Posted: September 28, 2009
Results First Submitted: January 29, 2016
Results First Posted: March 29, 2016
Last Update Posted: March 29, 2016
Last Verified: February 2016

Keywords provided by Translational Oncology Research International:
adenocarcinoma of the esophagus
adenocarcinoma of the stomach
recurrent esophageal cancer
stage III esophageal cancer
stage IV esophageal cancer
recurrent gastric cancer
stage III gastric cancer
stage IV gastric cancer

Additional relevant MeSH terms:
Adenocarcinoma
Stomach Neoplasms
Esophageal Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Head and Neck Neoplasms
Esophageal Diseases
Everolimus
Sirolimus
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents