Imatinib Mesylate in Treating Patients With Recurrent or Persistent Uterine Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00075400
First received: January 9, 2004
Last updated: May 6, 2015
Last verified: March 2014
Results First Received: May 6, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Recurrent Uterine Sarcoma
Uterine Carcinosarcoma
Interventions: Drug: imatinib mesylate
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
The study was activated on 1/5/2004 and closed to accrual on 8/1/2005.

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
Gleevec Gleevec™ 600 mg QD po continuously (a cycle will be defined as 28 days). If first cycle of Gleevec™ at 600 mg QD is tolerated without any significant toxicity, the dose can be escalated to 400 mg BID po Q 12 hours until disease progression or adverse effects prohibit further therapy.

Participant Flow:   Overall Study
    Gleevec  
STARTED     26  
COMPLETED     23 [1]
NOT COMPLETED     3  
Ineligible: wrong primary                 1  
Never treated                 2  
[1] Eligible and treated patients.



  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.
Eligible and treated patients.

Reporting Groups
  Description
Gleevec Gleevec™ 600 mg QD po continuously (a cycle will be defined as 28 days). If first cycle of Gleevec™ at 600 mg QD is tolerated without any significant toxicity, the dose can be escalated to 400 mg BID po Q 12 hours until disease progression or adverse effects prohibit further therapy.

Baseline Measures
    Gleevec  
Number of Participants  
[units: participants]
  23  
Age  
[units: years]
Mean (Standard Deviation)
  64.5  (10.2)  
Age, Customized  
[units: participants]
 
40-49 years     3  
50-59 years     3  
60-69 years     11  
70-79 years     4  
80-89 years     2  
Gender  
[units: participants]
 
Female     23  
Male     0  
Region of Enrollment  
[units: participants]
 
United States     23  
FIGO (International Federation of Gynecology and Obstetrics) Stage Recurrent/Persistent  
[units: participants]
  23  
Histologic Type  
[units: participants]
 
Carcinosarcoma-homologous     3  
Carcinosarcoma-heterologous     8  
Carcinosarcoma, MMT     12  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Progression-free Survival (PFS) > 6 Months   [ Time Frame: For those patients whose disease can be evaluated by physical examination, progression was assessed prior to each 28-day cycle. CT scan or MRI if used to follow measurable disease every other cycle for the first 6 months; every 6 months thereafter. ]

2.  Secondary:   Tumor Response   [ Time Frame: For those patients whose disease can be evaluated by physical examination, response was assessed prior to each 28-day cycle. CT scan or MRI if used to follow measurable disease every other cycle for the first 6 months; every 6 months thereafter. ]

3.  Secondary:   Overall Survival   [ Time Frame: From study entry to death or last contact, up to 5 years. ]

4.  Primary:   Incidence of Adverse Effects as Assessed by CTCAE v 3.0   [ Time Frame: Up to 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

5.  Secondary:   Duration of PFS   [ Time Frame: Up to 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   Initial Performance Status   [ Time Frame: Baseline ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

7.  Secondary:   Initial Histologic Grade   [ Time Frame: Baseline ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

8.  Secondary:   c-KIT Expression Levels in Archived, Formalin-fixed, Paraffin-embedded Primary Tumor Tissue by Immunohistochemistry (IHC)   [ Time Frame: Baseline ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

9.  Secondary:   PDGFR Expression Levels in Archived, Formalin-fixed, Paraffin-embedded Primary Tumor Tissue by IHC   [ Time Frame: Baseline ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

10.  Secondary:   AKT2 Expression Levels in Archived, Formalin-fixed, Paraffin-embedded Primary Tumor Tissue by IHC   [ Time Frame: Baseline ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

11.  Secondary:   p-AKT2 Expression Levels in Archived, Formalin-fixed, Paraffin-embedded Primary Tumor Tissue   [ Time Frame: Baseline ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  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 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Angela M. Kuras, Associate Director of Data Management
Organization: NRG Oncology Statistics and Data Management Center - Buffalo
phone: 716-845-7733
e-mail: kurasa@nrgoncology.org



Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00075400     History of Changes
Other Study ID Numbers: NCI-2014-00653
NCI-2014-00653 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000346361
GOG-0230C ( Other Identifier: Gynecologic Oncology Group )
GOG-0230C ( Other Identifier: CTEP )
U10CA027469 ( US NIH Grant/Contract Award Number )
Study First Received: January 9, 2004
Results First Received: May 6, 2015
Last Updated: May 6, 2015
Health Authority: United States: Food and Drug Administration