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

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. Identifier: NCT00985192
Recruitment Status : Completed
First Posted : September 28, 2009
Results First Posted : March 29, 2016
Last Update Posted : March 29, 2016
National Cancer Institute (NCI)
University of California, Los Angeles
Information provided by (Responsible Party):
Translational Oncology Research International

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Esophageal Cancer
Gastric Cancer
Interventions: Drug: everolimus
Other: laboratory biomarker analysis

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 49 patients were enrolled between December of 2007 and November of 2009 from 18 participating sites including the University of California Los Angeles hospitals and clinics participating in the TRIO-US Network.

Reporting Groups

Patients receive oral everolimus once daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity


laboratory biomarker analysis

Participant Flow:   Overall Study
Withdrawal by Subject                1 
Disease Progression                1 
Determined to be Ineligible During Trial                2 

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Of the 49 subjects enrolled, only 45 were determined to be evaluable due to subject withdrawal, an adverse event, and 2 subjects later determined to be ineligible. 45 is the analysis population

Reporting Groups

Patients receive oral everolimus once daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity


laboratory biomarker analysis

Baseline Measures
Overall Participants Analyzed 
[Units: Participants]
[Units: Years]
Median (Full Range)
 (38 to 82) 
[Units: Participants]
Female   8 
Male   37 
Race/Ethnicity, Customized 
[Units: Participants]
White   28 
Hispanic   10 
Asian   4 
Black   3 
Region of Enrollment 
[Units: Participants]
United States   45 
Disease Site 
[Units: Participants]
Gastric   21 
Gastroesophageal Junction   13 
Esophagus   11 
Eastern Cooperative Oncology Group (ECOG) score [1] 
[Units: Participants]

The ECOG score runs from 0 to 5, with 0 denoting perfect health and 5 death. Evaluation is made during examination by a Physician.

0 – Asymptomatic 1 – Symptomatic but completely ambulatory 2 – Symptomatic, <50% in bed during the day 3 – Symptomatic, >50% in bed, but not bedbound (Capable of only limited self-care, confined to bed or chair 50% or more of waking hours) 4 – Bedbound (Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair) 5 – Death

  Outcome Measures

1.  Primary:   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. ]

2.  Secondary:   Overall Survival   [ Time Frame: 2.5 year ]

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

4.  Secondary:   Observed Biomarkers   [ Time Frame: 30 months ]

5.  Secondary:   Biomarker Correlations: Progression Free Survival   [ Time Frame: 30 months ]

6.  Secondary:   Biomarker Correlations: Time to Progression   [ Time Frame: 30 months ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
This study had several limitations with the major weakness being that it was a single- rm, non-comparative study. At the time this study was launched, a Japanese report indicating a DCR was 50 % was not yet reported.

  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact:  
Name/Title: Dr. Zev Wainberg
Organization: UCLA GI Oncology Program, David Geffen School of Medicine at UCLA
phone: 310 794-6500

Responsible Party: Translational Oncology Research International Identifier: NCT00985192     History of Changes
Other Study ID Numbers: CDR0000655574
P30CA016042 ( U.S. NIH Grant/Contract )
IRB# 09-07-061-01
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