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Trabectedin in Treating Patients With Advanced, Persistent, or Recurrent Leiomyosarcoma of the Uterus

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.
ClinicalTrials.gov Identifier: NCT00379145
Recruitment Status : Completed
First Posted : September 21, 2006
Results First Posted : December 12, 2017
Last Update Posted : December 12, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Sarcoma
Intervention: Drug: trabectedin

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This trial was opened to patient entry on June 4, 2007 and was closed to accrual on November 3, 2008.

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
Trabectidin Trabectedin 1.5 mg/m2 IV over 24 hours every 3 weeks (one cycle) until disease progression or adverse effects prohibit further therapy

Participant Flow:   Overall Study
    Trabectidin
STARTED   20 
COMPLETED [1]   20 
NOT COMPLETED   0 
[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
  Description
Trabectidin Trabectedin 1.5 mg/m2 IV over 24 hours every 3 weeks (one cycle) until disease progression or adverse effects prohibit further therapy

Baseline Measures
   Trabectidin 
Overall Participants Analyzed 
[Units: Participants]
 20 
Age, Customized 
[Units: Participants]
Count of Participants
 
<40 years      1   5.0% 
40-49 years      3  15.0% 
50-59 years      5  25.0% 
60-69 years      7  35.0% 
70-79 years      3  15.0% 
>79 years      1   5.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      20 100.0% 
Male      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      1   5.0% 
Asian      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      4  20.0% 
White      15  75.0% 
More than one race      0   0.0% 
Unknown or Not Reported      0   0.0% 


  Outcome Measures

1.  Primary:   Number of Patients With Objective Tumor Response Rate (Complete Response [CR] or Partial Response [PR]) Using RECIST Version 1.0   [ Time Frame: CT scan or MRI if used to follow lesion for measurable disease every other cycle until disease progression for up to 5 years. ]

2.  Primary:   Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0   [ Time Frame: Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in 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 Kuras on behalf of James Kauderer
Organization: NRG Oncology
phone: 716-845-5702
e-mail: kurasa@nrgoncology.org


Publications of Results:
Other Publications:

Responsible Party: Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT00379145     History of Changes
Other Study ID Numbers: GOG-0087M
CDR0000502192 ( Other Identifier: CDR )
NCI-2009-00573 ( Other Identifier: NCI )
First Submitted: September 19, 2006
First Posted: September 21, 2006
Results First Submitted: October 13, 2017
Results First Posted: December 12, 2017
Last Update Posted: December 12, 2017