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Thalidomide in Treating Patients With Recurrent or Persistent Carcinosarcoma 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: NCT00025506
Recruitment Status : Completed
First Posted : January 27, 2003
Results First Posted : May 27, 2015
Last Update Posted : January 19, 2018
Sponsor:
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 Corpus Sarcoma
Uterine Carcinosarcoma
Interventions: Other: Laboratory Biomarker Analysis
Drug: Thalidomide

  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 9/4/2001 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
No text entered.

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

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 
Overall Participants Analyzed 
[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 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      45 100.0% 
Male      0   0.0% 
Region of Enrollment 
[Units: Participants]
 
United States   45 
Histologic type 
[Units: Participants]
 
Carcinosarcoma-homologous   22 
Carcinosarcoma-heterologous   16 
Carcinosarcoma, MMT   7 


  Outcome Measures

1.  Primary:   Progression-free Survival (PFS) > 6 Months   [ Time Frame: Every other cycle for 6 months ]

2.  Primary:   Frequency and Severity of Adverse Effects as Assessed by Common Toxicity Criteria (CTC) v2.0   [ Time Frame: Each cycle during treatment and 30 days after the last treatment (average 4 months) ]

3.  Secondary:   Progression Free Survival   [ Time Frame: Every other cycle until progression or death, up to 5 years. ]

4.  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. (average = 4 months) ]

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

6.  Secondary:   Initial Performance Status   [ Time Frame: baseline ]

7.  Secondary:   Initial Histologic Grade   [ Time Frame: Baseline ]

8.  Other Pre-specified:   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.  

9.  Other Pre-specified:   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.  


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



Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00025506     History of Changes
Other Study ID Numbers: NCI-2012-02421
NCI-2012-02421 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000068967
GOG-0230B ( Other Identifier: Gynecologic Oncology Group )
GOG-0230B ( Other Identifier: CTEP )
U10CA027469 ( U.S. NIH Grant/Contract )
First Submitted: October 11, 2001
First Posted: January 27, 2003
Results First Submitted: May 7, 2015
Results First Posted: May 27, 2015
Last Update Posted: January 19, 2018