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Imatinib Mesylate With or Without Bevacizumab in Treating Patients With Metastatic or Unresectable Gastrointestinal Stromal Tumor (S0502)

This study has been terminated.
(The trial failed to accrue)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00324987
First Posted: May 11, 2006
Last Update Posted: September 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: May 10, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Gastrointestinal Stromal Tumor
Interventions: Biological: Bevacizumab
Drug: Imatinib Mesylate
Other: Laboratory Biomarker Analysis
Other: Pharmacological Study

  Participant Flow
  Hide Participant Flow

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
Imatinib + Bevacizumab Patients receive 400 or 800mg imatinib mesylate PO QD on days 1-21 and 15 mg/kg bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Imatinib Patients receive 400 or 800mg imatinib mesylate PO QD on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.

Participant Flow:   Overall Study
    Imatinib + Bevacizumab   Imatinib
STARTED   6   6 
COMPLETED   0 [1]   0 [1] 
NOT COMPLETED   6   6 
Adverse Event                2                1 
Withdrawal by Subject                1                1 
Progression                1                1 
symptomatic deterioration, toxicity, etc                2                3 
[1] Patients were to be treated until progression



  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
Imatinib + Bevacizumab Patients receive 400 or 800mg imatinib mesylate PO QD on days 1-21 and 15 mg/kg bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Imatinib Patients receive 400 or 800mg imatinib mesylate PO QD on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Total Total of all reporting groups

Baseline Measures
   Imatinib + Bevacizumab   Imatinib   Total 
Overall Participants Analyzed 
[Units: Participants]
 6   6   12 
Age 
[Units: Years]
Median (Full Range)
 64.7 
 (49.4 to 82.9) 
 57.9 
 (44.0 to 68.5) 
 59.9 
 (44.0 to 82.9) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      3  50.0%      5  83.3%      8  66.7% 
Male      3  50.0%      1  16.7%      4  33.3% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      0   0.0%      0   0.0%      0   0.0% 
Not Hispanic or Latino      5  83.3%      5  83.3%      10  83.3% 
Unknown or Not Reported      1  16.7%      1  16.7%      2  16.7% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      1  16.7%      1  16.7%      2  16.7% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      0   0.0%      0   0.0%      0   0.0% 
White      5  83.3%      4  66.7%      9  75.0% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      1  16.7%      1   8.3% 
Performance Status [1] 
[Units: Participants]
     
 5   4   9 
>=1   1   2   3 
[1]

Patients graded according to the Zubrod Perfromance Status Scale:

0: Fully active, able to carry on all pre-disease performance without restriction; 1: Restricted in physically strenuous activity but ambulatory and able to carry out work of a light sedentary nature; 2: Ambulatory and capable of self-care but unable to carry out any work activities, up and about more than 50% of waking hours; 3: Capable of limited self-care, confined to bed or chair more than 50% of waking hours; 4: Completely disabled, cannot carry on any self-care, totally confined to bed or chair.

Disease Status 
[Units: Participants]
     
Measurable   5   5   10 
Non-measurable   1   1   2 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Progression Free Survival   [ Time Frame: Up to 7 years ]

2.  Secondary:   Response Rate   [ Time Frame: Up to 7 years ]

3.  Secondary:   Overall Survival   [ Time Frame: up to 7 years ]

4.  Secondary:   Central-review Based Progression-free Survival (CRb-PFS)   [ Time Frame: up to 7 years ]

5.  Secondary:   Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug   [ Time Frame: Up to 7 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
Trial was terminated due to poor accrual. No conclusions should be drawn from the reported data due to the small sample size.


  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: SWOG Statistician
Organization: SWOG Statistical Center
phone: 206-667-4408


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

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00324987     History of Changes
Other Study ID Numbers: NCI-2009-00776
NCI-2009-00776 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000482236
S0502 ( Other Identifier: SWOG )
S0502 ( Other Identifier: CTEP )
U10CA180888 ( U.S. NIH Grant/Contract )
U10CA032102 ( U.S. NIH Grant/Contract )
First Submitted: May 10, 2006
First Posted: May 11, 2006
Results First Submitted: May 10, 2017
Results First Posted: September 14, 2017
Last Update Posted: September 14, 2017



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