Oxaliplatin and Gemcitabine Followed by Radiation Therapy in the Management of Mixed Mullerian Tumors of the Uterus

This study has been completed.
Sponsor:
Collaborators:
Sanofi
Brigham and Women's Hospital
Massachusetts General Hospital
Information provided by (Responsible Party):
Susana M. Campos, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00476086
First received: May 17, 2007
Last updated: May 5, 2016
Last verified: May 2016
Results First Received: March 10, 2016  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Mixed Mullerian Tumors of the Uterus
Interventions: Drug: Gemcitabine
Drug: Oxaliplatin
Radiation: Radiation

  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
20 participants were enrolled between May 2007 and August 2011.

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
Oxaliplatin/ Gemcitabine Then Radiation Patients received IV chemotherapy on days 1 and 15 of a 4-week cycle: gemcitabine 1000 mg/m2 and oxaliplatin 65 mg/m2 for up to 3 cycles. Two dose reductions per study drug were permitted. On study, chemotherapy was followed by radiation therapy (RT) within 4-6 weeks of last chemotherapy. RT regimen was tumor-volume directed.

Participant Flow:   Overall Study
    Oxaliplatin/ Gemcitabine Then Radiation  
STARTED     20  
Received Chemotherapy     19  
Received Radiation     15  
COMPLETED     15  
NOT COMPLETED     5  
Alternative therapy                 1  
Progressive Disease                 4  



  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.
The baseline population is comprised of all enrolled patients.

Reporting Groups
  Description
Oxaliplatin/ Gemcitabine Then Radiation

Patients rcvd IV chemotherapy on days 1 and 15 of a 4-week cycle: gemcitabine 1000 mg/m2 and oxaliplatin 65 mg/m2 for up to 3 cycles. Two dose reductions per study drug were permitted. On study, chemotherapy was followed by radiation therapy (RT) within 4-6 weeks of last chemotherapy. RT regimen was tumor-volume directed.

on


Baseline Measures
    Oxaliplatin/ Gemcitabine Then Radiation  
Number of Participants  
[units: participants]
  20  
Age  
[units: years]
Mean (Full Range)
  63  
  (49 to 73)  
Gender  
[units: participants]
 
Female     20  
Male     0  
Region of Enrollment  
[units: participants]
 
United States     20  



  Outcome Measures
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1.  Primary:   Chemotherapy Completion Rate   [ Time Frame: 3 cycles of chemotherapy which approximates 3 months given the 28-day cycle ]

2.  Secondary:   Radiation Therapy Completion Rate   [ Time Frame: Radiation therapy was within 4-6 weeks of last chemotherapy dose. Participants received up to 5 weeks of radiation therapy. ]


  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: Susana M. Campos, MD, MPH
Organization: Dana-Farber Cancer Institute
phone: 617-632-5269
e-mail: susanna_campos@dfci.harvard.edu



Responsible Party: Susana M. Campos, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00476086     History of Changes
Other Study ID Numbers: 06-063
Study First Received: May 17, 2007
Results First Received: March 10, 2016
Last Updated: May 5, 2016
Health Authority: United States: Institutional Review Board