Ixabepilone in Treating Patients With Recurrent or Persistent Leiomyosarcoma of the Uterus Previously Treated With Chemotherapy

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01220609
First received: October 12, 2010
Last updated: September 30, 2015
Last verified: January 2015
Results First Received: September 30, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Recurrent Uterine Corpus Sarcoma
Uterine Corpus Leiomyosarcoma
Interventions: Drug: Ixabepilone
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
No text entered.

Reporting Groups
  Description
Ixabepilone Ixabepilone administered at 40 mg/m2 IV infusion over 3 hours on day 1 of a 21-day cycle until disease progression or adverse effects prohibit further treatment

Participant Flow:   Overall Study
    Ixabepilone  
STARTED     26  
COMPLETED     23 [1]
NOT COMPLETED     3  
Ineligible-Wrong primary cancer site                 1  
Ineligible- Wrong cell type                 1  
Ineligible-Never treated                 1  
[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
Ixabepilone Ixabepilone administered at 40 mg/m2 IV infusion over 3 hours on day 1 of a 21-day cycle until disease progression or adverse effects prohibit further treatment

Baseline Measures
    Ixabepilone  
Number of Participants  
[units: participants]
  23  
Age  
[units: years]
Mean (Standard Deviation)
  55.5  (7.1)  
Age, Customized  
[units: participants]
 
40-49 years     5  
50-59 years     12  
60-69 years     6  
Gender  
[units: participants]
 
Female     23  
Male     0  
International Federation of Gynecology and Obstetrics (FIGO) Stage - Recurrent/Persistent  
[units: participants]
  23  
Histologic Type  
[units: participants]
 
Leiomyosarcoma     22  
Carcinosarcoma, MMT     1  



  Outcome Measures
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1.  Primary:   Tumor Response   [ Time Frame: Every other cycle for the first 6 months; then every 3 months thereafter until completion of study treatment; and at any other time if clinically indicated based on symptoms or physical signs suggestive of progressive disease. ]

2.  Secondary:   Progression-free Survival   [ Time Frame: From study entry to disease progression, death or date of last contact, whichever occurs first, up to 5 years of follow-up. ]

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

4.  Primary:   Frequency and Severity of Adverse Events as Assessed by NCI CTCAE v. 4.0   [ Time Frame: Every cycle until completion of study treatment up to 30 days after stopping study treatment ]
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 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


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01220609     History of Changes
Other Study ID Numbers: NCI-2011-02656
NCI-2011-02656 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000686644
GOG-0131H ( Other Identifier: CTEP )
U10CA027469 ( US NIH Grant/Contract Award Number )
U10CA180868 ( US NIH Grant/Contract Award Number )
Study First Received: October 12, 2010
Results First Received: September 30, 2015
Last Updated: September 30, 2015
Health Authority: United States: Food and Drug Administration