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Trial record 1 of 1 for:    gog 0250
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Gemcitabine Hydrochloride and Docetaxel With or Without Bevacizumab in Treating Patients With Advanced or Recurrent Uterine Leiomyosarcoma

This study has been terminated.
(The study was targeted to accrue 130 patients, but closed early for futility.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01012297
First Posted: November 13, 2009
Last Update Posted: July 14, 2017
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.
Information provided by (Responsible Party):
National Cancer Institute (NCI)
Results First Submitted: January 26, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Recurrent Uterine Corpus Sarcoma
Stage IIIA Uterine Sarcoma
Stage IIIB Uterine Sarcoma
Stage IIIC Uterine Sarcoma
Stage IVA Uterine Sarcoma
Stage IVB Uterine Sarcoma
Uterine Corpus Leiomyosarcoma
Interventions: Biological: Bevacizumab
Drug: Docetaxel
Biological: Filgrastim
Drug: Gemcitabine Hydrochloride
Biological: Pegfilgrastim
Other: Placebo

  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
No text entered.

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
Arm I Gem+Doce+Placebo

Patients receive a placebo IV over 30-90 minutes on day 1, gemcitabine hydrochloride IV over 90 minutes on days 1 and 8, and docetaxel IV over 60 minutes on day 8. Patients also receive filgrastim subcutaneously (SC) on days 9-15 or pegfilgrastim SC on day 9 or 10.

Docetaxel: Given IV

Filgrastim: Given SC

Gemcitabine Hydrochloride: Given IV

Pegfilgrastim: Given SC

Placebo: Given IV

Arm II Gem+Doce+Bev

Patients receive bevacizumab IV over 30-90 minutes on day 1, gemcitabine hydrochloride IV over 90 minutes on days 1 and 8, and docetaxel IV over 60 minutes on day 8. Patients also receive filgrastim SC on days 9-15 or pegfilgrastim SC on day 9 or 10.

Bevacizumab: Given IV

Docetaxel: Given IV

Filgrastim: Given SC

Gemcitabine Hydrochloride: Given IV

Pegfilgrastim: Given SC


Participant Flow:   Overall Study
    Arm I Gem+Doce+Placebo   Arm II Gem+Doce+Bev
STARTED   54   53 
COMPLETED   54   53 
NOT COMPLETED   0   0 



  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.
No text entered.

Reporting Groups
  Description
Arm I Gem+Doce+Placebo

Patients receive a placebo IV over 30-90 minutes on day 1, gemcitabine hydrochloride IV over 90 minutes on days 1 and 8, and docetaxel IV over 60 minutes on day 8. Patients also receive filgrastim subcutaneously (SC) on days 9-15 or pegfilgrastim SC on day 9 or 10.

Docetaxel: Given IV

Filgrastim: Given SC

Gemcitabine Hydrochloride: Given IV

Pegfilgrastim: Given SC

Placebo: Given IV

Arm II Gem+Doce+Bev

Patients receive bevacizumab IV over 30-90 minutes on day 1, gemcitabine hydrochloride IV over 90 minutes on days 1 and 8, and docetaxel IV over 60 minutes on day 8. Patients also receive filgrastim SC on days 9-15 or pegfilgrastim SC on day 9 or 10.

Bevacizumab: Given IV

Docetaxel: Given IV

Filgrastim: Given SC

Gemcitabine Hydrochloride: Given IV

Pegfilgrastim: Given SC

Total Total of all reporting groups

Baseline Measures
   Arm I Gem+Doce+Placebo   Arm II Gem+Doce+Bev   Total 
Overall Participants Analyzed 
[Units: Participants]
 54   53   107 
Age 
[Units: Years]
Mean (Standard Deviation)
 57.5  (8.1)   54.0  (8.7)   55.7  (8.6) 
Age, Customized 
[Units: Participants]
Count of Participants
     
Age Groups       
20-29 years      0   0.0%      1   1.9%      1   0.9% 
30-39 years      0   0.0%      3   5.7%      3   2.8% 
40-49 years      11  20.4%      12  22.6%      23  21.5% 
50-59 years      24  44.4%      25  47.2%      49  45.8% 
60-69 years      19  35.2%      12  22.6%      31  29.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      54 100.0%      53 100.0%      107 100.0% 
Male      0   0.0%      0   0.0%      0   0.0% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      4   7.4%      3   5.7%      7   6.5% 
Not Hispanic or Latino      48  88.9%      43  81.1%      91  85.0% 
Unknown or Not Reported      2   3.7%      7  13.2%      9   8.4% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      1   1.9%      1   0.9% 
Asian      1   1.9%      1   1.9%      2   1.9% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      6  11.1%      12  22.6%      18  16.8% 
White      46  85.2%      36  67.9%      82  76.6% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      1   1.9%      3   5.7%      4   3.7% 
Prior whole pelvic radiation 
[Units: Participants]
Count of Participants
     
Yes   11   11   22 
No   43   42   85 
Performance Status 
[Units: Participants]
Count of Participants
     
0: Asymptomatic   38   41   79 
1: Symptomatic, fully ambulatory   15   11   26 
2: Symptomatic, in bed < 50% of time   1   1   2 
FIGO Stage [1] 
[Units: Participants]
Count of Participants
     
 20   11   31 
 4   0   4 
 3   5   8 
 22   30   52 
unknown   5   7   12 
[1] FIGO Stage describes disease burden at time of surgery. Stage 1 indicates the cancer has not spread beyond the uterus. Stage 4 indicates cancer metastasis in distant organs.
Cell Type 
[Units: Participants]
Count of Participants
     
Leiomyosarcoma      52  96.3%      52  98.1%      104  97.2% 
Sarcoma, Unsp.      1   1.9%      0   0.0%      1   0.9% 
Carcinsarcoma      0   0.0%      1   1.9%      1   0.9% 
Unknown      1   1.9%      0   0.0%      1   0.9% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Progression-free Survival   [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months ]

2.  Secondary:   Overall Survival   [ Time Frame: Up to 5 years ]

3.  Secondary:   Frequency and Severity of Adverse Effects as Assessed by the CTCAE Version 4.0   [ Time Frame: Up to 5 years ]

4.  Secondary:   Objective Response Rate as Measured by RECIST 1.1 Criteria   [ Time Frame: Up to 5 years ]


  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
The study was targeted to accrue 130 patients, but closed early for futility. Early termination leading to small numbers of subjects analyzed.


  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 Administration and Operations
Organization: NRG Oncology Statistics and Data Management Center - Buffalo
phone: (716) 845-5702
e-mail: kurasa@nrgoncology.org


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01012297     History of Changes
Other Study ID Numbers: NCI-2010-01738
NCI-2010-01738 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000659024
GOG-0250
GOG-0250 ( Other Identifier: NRG Oncology )
GOG-0250 ( Other Identifier: CTEP )
U10CA027469 ( U.S. NIH Grant/Contract )
First Submitted: November 12, 2009
First Posted: November 13, 2009
Results First Submitted: January 26, 2017
Results First Posted: July 14, 2017
Last Update Posted: July 14, 2017



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