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Sunitinib in Treating Patients With Metastatic, Locally Advanced, or Locally Recurrent Sarcomas

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ClinicalTrials.gov Identifier: NCT00474994
Recruitment Status : Completed
First Posted : May 17, 2007
Results First Posted : January 20, 2016
Last Update Posted : January 20, 2016
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Dana-Farber Cancer Institute
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Adult Malignant Fibrous Histiocytoma of Bone
Desmoid Tumor
Endometrial Cancer
Ovarian Cancer
Sarcoma
Small Intestine Cancer
Intervention Drug: sunitinib malate
Enrollment 53
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Sunitinib (Sutent®, SU11248) in Non-GIST Sarcomas
Hide Arm/Group Description Sunitinib (Sutent®, SU11248) in Non-GIST Sarcomas
Period Title: Overall Study
Started 53
Completed 48
Not Completed 5
Reason Not Completed
Patient Not treated             1
Patient evaluable for toxicity only             3
Patient found to be ineligible             1
Arm/Group Title Sunitinib (Sutent®, SU11248) in Non-GIST Sarcomas
Hide Arm/Group Description Sunitinib (Sutent®, SU11248) in Non-GIST Sarcomas
Overall Number of Baseline Participants 53
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 53 participants
<=18 years
1
   1.9%
Between 18 and 65 years
45
  84.9%
>=65 years
7
  13.2%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 53 participants
Female
28
  52.8%
Male
25
  47.2%
1.Primary Outcome
Title Overall Objective Response
Hide Description as assessed by RECIST criteria
Time Frame 2 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sunitinib (Sutent®, SU11248) in Non-GIST Sarcomas
Hide Arm/Group Description:
Sunitinib (Sutent®, SU11248) in Non-GIST Sarcomas
Overall Number of Participants Analyzed 48
Measure Type: Number
Unit of Measure: participants
Partial Response (PR) 1
Stable Disease (SD) 21
Progression of Disease (POD) 26
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Sunitinib (Sutent®, SU11248) in Non-GIST Sarcomas
Hide Arm/Group Description Sunitinib (Sutent®, SU11248) in Non-GIST Sarcomas
All-Cause Mortality
Sunitinib (Sutent®, SU11248) in Non-GIST Sarcomas
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Sunitinib (Sutent®, SU11248) in Non-GIST Sarcomas
Affected / at Risk (%) # Events
Total   9/53 (16.98%)    
Blood and lymphatic system disorders   
Hemoglobin  1  1/53 (1.89%)  2
Platelets  1  1/53 (1.89%)  1
Gastrointestinal disorders   
Pneumothorax  1  1/53 (1.89%)  1
Ulcer, Duodenum  1  2/53 (3.77%)  3
General disorders   
Death not associated with CTCAE term- Death NOS  1  1/53 (1.89%)  1
Death not associated with CTCAE term-Disease progression NOS  1  2/53 (3.77%)  2
Pain - Abdomen NOS  1  1/53 (1.89%)  1
Nervous system disorders   
Dizziness  1  1/53 (1.89%)  1
Seizure  1  1/53 (1.89%)  2
Respiratory, thoracic and mediastinal disorders   
Thrombosis/thrombus/embolism  1  1/53 (1.89%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTC-3.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Sunitinib (Sutent®, SU11248) in Non-GIST Sarcomas
Affected / at Risk (%) # Events
Total   37/53 (69.81%)    
Blood and lymphatic system disorders   
AST, SGOT  1  3/53 (5.66%)  3
Hemoglobin  1  5/53 (9.43%)  5
Leukocytes (total WBC)  1  14/53 (26.42%)  14
Lymphopenia  1  3/53 (5.66%)  3
Neutrophils/granulocytes (ANC/AGC)  1  15/53 (28.30%)  15
Platelets  1  7/53 (13.21%)  7
Cardiac disorders   
Hypertension  1  9/53 (16.98%)  9
Gastrointestinal disorders   
Diarrhea  1  7/53 (13.21%)  7
Gastrointestinal, other  1  3/53 (5.66%)  3
General disorders   
Fatigue (asthenia, lethargy, malaise)  1  6/53 (11.32%)  6
Mucositis (Clincal exam)- Oral cavity  1  7/53 (13.21%)  7
Metabolism and nutrition disorders   
Bilirubin (hyperbilirubinemia)  1  4/53 (7.55%)  4
Skin and subcutaneous tissue disorders   
Rash: hand-foot skin reaction  1  7/53 (13.21%)  7
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTC-3.0
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Mary Keohan
Organization: Memorial Sloan Kettering Cancer Center
Phone: 646-888-4160
Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00474994     History of Changes
Other Study ID Numbers: 07-054
P30CA008748 ( U.S. NIH Grant/Contract )
MSKCC-07054
PFIZER-MSKCC-07054
First Submitted: May 16, 2007
First Posted: May 17, 2007
Results First Submitted: December 15, 2015
Results First Posted: January 20, 2016
Last Update Posted: January 20, 2016