Ixabepilone in Treating Patients With Recurrent or Persistent Endometrial Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00095979
First received: November 9, 2004
Last updated: May 5, 2015
Last verified: January 2013
Results First Received: May 5, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Endometrial Adenocarcinoma
Recurrent Endometrial Carcinoma
Stage IV Endometrial Carcinoma
Intervention: Drug: ixabepilone

  Participant Flow
  Hide Participant Flow

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 5/2/2005 and closed to accrual on 1/3/2008 (suspended from 4/3/2006 to 4/1/2007).

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 40 mg/m2 administered as 3-hour infusion on day 1 of a 21-day cycle until disease progression or adverse effects prohibit further treatment

Participant Flow:   Overall Study
    Ixabepilone  
STARTED     52  
COMPLETED     50  
NOT COMPLETED     2  
Ineligible: Second primary cancer site                 2  



  Baseline Characteristics
  Hide Baseline Characteristics

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 40 mg/m2 administered as 3-hour infusion 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]
  50  
Age  
[units: years]
Mean (Standard Deviation)
  64.8  (9.4)  
Age, Customized  
[units: participants]
 
20-29 years     0  
30-39 years     0  
40-49 years     2  
50-59 years     11  
60-69 years     19  
70-79 years     16  
80-89 years     2  
Gender  
[units: participants]
 
Female     50  
Male     0  
International Federation of Gynecology and Obstetrics (FIGO) Stage Recurrent/Persistent  
[units: participants]
  50  
Histologic Type  
[units: participants]
 
Adenocarcinoma, Unspecified     1  
Clear Cell Carcinoma     1  
Endometrioid Adenocarcinoma     22  
Mixed Epithelial Carcinoma     4  
Serous Adenocarcinoma     21  
Carcinosarcoma-homologous     1  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Tumor Response   [ Time Frame: Every other cycle for first 6 months; then every six 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 Observed Adverse Effects   [ 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
  Hide Limitations and Caveats

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
No text entered.


  More Information
  Hide More Information

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: NCT00095979     History of Changes
Other Study ID Numbers: NCI-2012-02628
NCI-2012-02628 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000391849
GOG-0129P ( Other Identifier: Gynecologic Oncology Group )
GOG-0129P ( Other Identifier: CTEP )
U10CA027469 ( US NIH Grant/Contract Award Number )
Study First Received: November 9, 2004
Results First Received: May 5, 2015
Last Updated: May 5, 2015
Health Authority: United States: Food and Drug Administration