Thalidomide in Treating Patients With Recurrent or Persistent Carcinosarcoma of the Uterus

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00025506
First received: October 11, 2001
Last updated: May 7, 2015
Last verified: December 2013
Results First Received: May 7, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Recurrent Uterine Corpus Sarcoma
Uterine Carcinosarcoma
Interventions: Other: Laboratory Biomarker Analysis
Drug: Thalidomide

  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
The study was activated on 9/4/2001 and closed to accrual on 3/3/2008 (suspended from 6/30/2003 to 8/1/2005).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
None.

Reporting Groups
  Description
Thalidomide Thalidomide 200 mg PO once a day initial dose (each 28-day period will be considered one cycle). Dose increased by 200 mg every 2 weeks to maximum dose of 1000 mg/day until disease progression or adverse effects prohibit further therapy.

Participant Flow:   Overall Study
    Thalidomide  
STARTED     55  
COMPLETED     45 [1]
NOT COMPLETED     10  
Ineligible: clerical error                 1  
Ineligible: wrong cell type                 5  
Ineligible: inadequate pathology                 2  
Never Treated                 2  
[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
Thalidomide Thalidomide 200 mg PO once a day initial dose (each 28-day period will be considered one cycle). Dose increased by 200 mg every 2 weeks to maximum dose of 1000 mg/day until disease progression or adverse effects prohibit further therapy.

Baseline Measures
    Thalidomide  
Number of Participants  
[units: participants]
  45  
Age  
[units: years]
Mean (Standard Deviation)
  65.6  (8.9)  
Age, Customized  
[units: participants]
 
30-39 years     1  
40-49 years     1  
50-59 years     7  
60-69 years     23  
70-79 years     11  
80-89 years     2  
Gender  
[units: participants]
 
Female     45  
Male     0  
Region of Enrollment  
[units: participants]
 
United States     45  
Histologic type  
[units: participants]
 
Carcinosarcoma-homologous     22  
Carcinosarcoma-heterologous     16  
Carcinosarcoma, MMT     7  



  Outcome Measures
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1.  Primary:   Progression-free Survival (PFS) > 6 Months   [ Time Frame: For those patients whose disease can be evaluated by physical examination, progression was assessed prior to each 28-day cycle. CT scan or MRI if used to follow lesion for measurable disease every other cycle ]

2.  Secondary:   Tumor Response   [ Time Frame: For those patients whose disease can be evaluated by physical examination, response was assessed prior to each 28-day cycle. CT scan or MRI if used to follow lesion for measurable disease every other cycle. ]

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

4.  Primary:   Frequency and Severity of Adverse Effects as Assessed by Common Toxicity Criteria (CTC) v2.0   [ Time Frame: Up to 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

5.  Secondary:   Progression Free Survival   [ Time Frame: For those patients whose disease can be evaluated by physical examination, progression was assessed prior to each 28-day cycle. CT scan or MRI if used to follow lesion for measurable disease every other cycle ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   Initial Performance Status and Histological Grade   [ Time Frame: Up to 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

7.  Secondary:   Serum and Plasma Concentrations of Vascular Endothelial Growth Factor (VEGF) and bFGF   [ Time Frame: Up to 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

8.  Secondary:   Serum and Plasma Concentrations of VEGF and bFGF With PFS   [ Time Frame: Up to 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  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
No text entered.


  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


No publications provided


Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00025506     History of Changes
Other Study ID Numbers: NCI-2012-02421, NCI-2012-02421, CDR0000068967, GOG-0230B, GOG-0230B, U10CA027469
Study First Received: October 11, 2001
Results First Received: May 7, 2015
Last Updated: May 7, 2015
Health Authority: United States: Food and Drug Administration