This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

Ixabepilone in Treating Patients With Recurrent or Persistent Uterine Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01168232
First received: July 22, 2010
Last updated: November 28, 2016
Last verified: November 2016
Results First Received: September 19, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Recurrent Uterine Sarcoma
Uterine Carcinosarcoma
Interventions: Drug: ixabepilone
Other: laboratory biomarker analysis

  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 9/7/2010 and closed to accrual on 8/26/2013 (suspended from 3/5/2012 to 9/30/2012).

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   42 
COMPLETED   34 [1] 
NOT COMPLETED   8 
Ineligible-Second primary cancer site                1 
Ineligible- Wrong cell type                6 
Ineligible-Inadequate pathology                1 
[1] Eligible and treated patients



  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 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 
Overall Participants Analyzed 
[Units: Participants]
 34 
Age 
[Units: Years]
Mean (Standard Deviation)
 66.9  (7.7) 
Age, Customized 
[Units: Participants]
Count of Participants
 
20-29 years   0 
30-39 years   0 
40-49 years   0 
50-59 years   7 
60-69 years   13 
70-79 years   12 
80-89 years   2 
Gender 
[Units: Participants]
Count of Participants
 
Female      34 100.0% 
Male      0   0.0% 
International Federation of Gynecology and Obstetrics (FIGO) Stage - Recurrent/Persistent 
[Units: Participants]
 34 
Histologic Type 
[Units: Participants]
 
Carcinosarcoma-heterologus   17 
Carcinosarcoma-homologous   11 
Carcinosarcoma, MMT   6 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Objective Tumor Response   [ Time Frame: Every other cycle for 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.1 cycle is 21 days ]

2.  Primary:   Adverse Events (Grade 3 or Higher) During Treatment Period.   [ Time Frame: During treatment and up to 30 days after stopping the study treatment ]

3.  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. ]

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


  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 Office
phone: 716-845-7733
e-mail: kurasa@nrgoncology.org



Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01168232     History of Changes
Other Study ID Numbers: NCI-2011-02056
NCI-2011-02056 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
GOG-0130F
CDR0000681684
GOG-0130F ( Other Identifier: Gynecologic Oncology Group )
GOG-0130F ( Other Identifier: CTEP )
U10CA027469 ( U.S. NIH Grant/Contract )
Study First Received: July 22, 2010
Results First Received: September 19, 2016
Last Updated: November 28, 2016