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

This study has been completed.
Sponsor:
Collaborators:
National Cancer Institute (NCI)
University of California, Los Angeles
Information provided by (Responsible Party):
Translational Oncology Research International
ClinicalTrials.gov Identifier:
NCT00985192
First received: September 25, 2009
Last updated: February 26, 2016
Last verified: February 2016
Results First Received: January 29, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Esophageal Cancer
Gastric Cancer
Interventions: Drug: everolimus
Other: laboratory biomarker analysis

  Participant Flow
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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
  Description
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

everolimus

laboratory biomarker analysis


Participant Flow:   Overall Study
    Everolimus  
STARTED     49  
COMPLETED     45  
NOT COMPLETED     4  
Withdrawal by Subject                 1  
Disease Progression                 1  
Determined to be Ineligible During Trial                 2  



  Baseline Characteristics
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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
  Description
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

everolimus

laboratory biomarker analysis


Baseline Measures
    Everolimus  
Number of Participants  
[units: participants]
  45  
Age  
[units: years]
Median (Full Range)
  64  
  (38 to 82)  
Gender  
[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]
 
0     15  
1     30  
[1]

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
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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
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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
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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
e-mail: zwainberg@mednet.ucla.edu



Responsible Party: Translational Oncology Research International
ClinicalTrials.gov Identifier: NCT00985192     History of Changes
Other Study ID Numbers: CDR0000655574
P30CA016042 ( US NIH Grant/Contract Award Number )
UCLA-TRIO-TORI-GI-06
IRB# 09-07-061-01
NOVARTIS-UCLA-TRIO-TORI-GI-06
Study First Received: September 25, 2009
Results First Received: January 29, 2016
Last Updated: February 26, 2016
Health Authority: United States: Food and Drug Administration