Trial record 1 of 1 for:    A Phase II Evaluation of Ixabepilone in the Treatment of Recurrent or Persistent Carcinosarcoma of the Uterus
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Ixabepilone in Treating Patients With Recurrent or Persistent Uterine Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01168232
Recruitment Status : Active, not recruiting
First Posted : July 23, 2010
Results First Posted : January 23, 2017
Last Update Posted : January 23, 2017
Information provided by (Responsible Party):
National Cancer Institute (NCI)

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

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
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
COMPLETED   34 [1] 
Ineligible-Second primary cancer site                1 
Ineligible- Wrong cell type                6 
Ineligible-Inadequate pathology                1 
[1] Eligible and treated patients

  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
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
Overall Participants Analyzed 
[Units: Participants]
[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 
[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]
Histologic Type 
[Units: Participants]
Carcinosarcoma-heterologus   17 
Carcinosarcoma-homologous   11 
Carcinosarcoma, MMT   6 

  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

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

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

Responsible Party: National Cancer Institute (NCI) Identifier: NCT01168232     History of Changes
Other Study ID Numbers: NCI-2011-02056
NCI-2011-02056 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
GOG-0130F ( Other Identifier: Gynecologic Oncology Group )
GOG-0130F ( Other Identifier: CTEP )
U10CA027469 ( U.S. NIH Grant/Contract )
First Submitted: July 22, 2010
First Posted: July 23, 2010
Results First Submitted: September 19, 2016
Results First Posted: January 23, 2017
Last Update Posted: January 23, 2017