Chemotherapy for Patients With Gastroesophageal Cancers Who Have Progressed After One Prior Chemo Regimen

This study has been terminated.
(As of 12/12/12 study closed to enrollment because study was determined to be ineffective.)
Sponsor:
Collaborators:
Roger Williams Medical Center
Rhode Island Hospital
The Miriam Hospital
Information provided by (Responsible Party):
howard safran, Brown University
ClinicalTrials.gov Identifier:
NCT01365130
First received: May 11, 2011
Last updated: June 12, 2014
Last verified: June 2014
Results First Received: February 20, 2014  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Esophageal
Gastrooesophageal Cancer
Gastric Cancer
Intervention: Drug: jevtana

  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
No text entered.

Reporting Groups
  Description
Real Drug

patients will receive Jevtana 25mg/m2, IV every 21 days until disease progression or unacceptable toxicity

jevtana: Cabazitaxel 25mg/m2, IV every 21 days until progression


Participant Flow:   Overall Study
    Real Drug  
STARTED     15 [1]
COMPLETED     13  
NOT COMPLETED     2  
Progression/worsening of Dx prior to txt                 2  
[1] 15 patients were enrolled to the study but only 13 went on to begin treatment



  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.
Patients with metastatic gastroesophageal cancer that have relapsed after at least one line of chemotherapy

Reporting Groups
  Description
Real Drug

patients will receive Jevtana 25mg/m2, IV every 21 days until disease progression or unacceptable toxicity

jevtana: Cabazitaxel 25mg/m2, IV every 21 days until progression


Baseline Measures
    Real Drug  
Number of Participants  
[units: participants]
  13  
Age  
[units: years]
Mean ± Standard Deviation
  67  ± 7.9  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     5  
>=65 years     8  
Gender  
[units: participants]
 
Female     2  
Male     11  
Region of Enrollment  
[units: participants]
 
United States     13  



  Outcome Measures

1.  Primary:   Number of Patients Without Progression at 3 Months   [ Time Frame: every three cycles approx every 63 days ]

2.  Secondary:   To Assess the Toxicity Associated With Cabazitaxel for Patients With Metastatic Gastroesophageal Adenocarcinomas That Have Progressed After at Least One Line of Therapy for Metastatic Disease.   [ Time Frame: at approx 6, 12 and 18 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes


  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
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  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: Howard Safran, MD
Organization: BrUOG
phone: 4018633000
e-mail: Hsafran@lifespan.org


No publications provided


Responsible Party: howard safran, Brown University
ClinicalTrials.gov Identifier: NCT01365130     History of Changes
Other Study ID Numbers: BrUOG 243
Study First Received: May 11, 2011
Results First Received: February 20, 2014
Last Updated: June 12, 2014
Health Authority: United States: Institutional Review Board