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Sorafenib in Treating Patients With Metastatic, Locally Advanced, or Recurrent Sarcoma

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ClinicalTrials.gov Identifier: NCT00245102
Recruitment Status : Completed
First Posted : October 27, 2005
Results First Posted : January 20, 2014
Last Update Posted : May 23, 2014
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 Adult Angiosarcoma
Adult Epithelioid Sarcoma
Adult Leiomyosarcoma
Adult Malignant Fibrous Histiocytoma
Adult Neurofibrosarcoma
Adult Synovial Sarcoma
Ovarian Sarcoma
Recurrent Adult Soft Tissue Sarcoma
Recurrent Uterine Sarcoma
Stage III Adult Soft Tissue Sarcoma
Stage III Uterine Sarcoma
Stage IV Adult Soft Tissue Sarcoma
Stage IV Uterine Sarcoma
Uterine Carcinosarcoma
Uterine Leiomyosarcoma
Intervention Drug: sorafenib tosylate
Enrollment 147

Recruitment Details Protocol Open to Accrual 09/09/2005 Protocol Closed to Accrual 07/22/2008 Primary Completion Date 03/22/2011 Recruitment Location is the medical clinic
Pre-assignment Details  
Arm/Group Title Angiosarcoma MPNST Leiomyosarcoma Undifferentiated Pleomorphic Sarcoma Fibrosarcoma Other Histology
Hide Arm/Group Description Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Period Title: Overall Study
Started 44 16 46 13 5 23
Completed 37 12 39 10 5 19
Not Completed 7 4 7 3 0 4
Reason Not Completed
Not Treated             1             0             1             0             0             0
Protocol Violation             1             0             0             0             0             0
Death             0             0             0             1             0             0
Adverse Event             4             2             5             1             0             2
Decline in performance             0             2             0             1             0             2
Participant needed surgery             0             0             1             0             0             0
Clinical progression             1             0             0             0             0             0
Arm/Group Title Angiosarcoma MPNST Leiomyosarcoma Undifferentiated Pleomorphic Sarcoma Fibrosarcoma Other Histology Total
Hide Arm/Group Description Sorafenib 400 mg PO BID Sorafenib 400 mg PO BID Sorafenib 400 mg PO BID Sorafenib 400 mg PO BID Sorafenib 400 mg PO BID Sorafenib 400 mg PO BID Total of all reporting groups
Overall Number of Baseline Participants 44 16 46 13 5 23 147
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 44 participants 16 participants 46 participants 13 participants 5 participants 23 participants 147 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
20
  45.5%
14
  87.5%
35
  76.1%
7
  53.8%
5
 100.0%
22
  95.7%
103
  70.1%
>=65 years
24
  54.5%
2
  12.5%
11
  23.9%
6
  46.2%
0
   0.0%
1
   4.3%
44
  29.9%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 44 participants 16 participants 46 participants 13 participants 5 participants 23 participants 147 participants
54  (50.91168825) 47.5  (34.64823228) 56  (33.9411255) 62.5  (31.81980515) 43.5  (10.60660172) 44  (31.11269837) 54  (50.91168825)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 44 participants 16 participants 46 participants 13 participants 5 participants 23 participants 147 participants
Female
25
  56.8%
9
  56.3%
37
  80.4%
8
  61.5%
4
  80.0%
11
  47.8%
94
  63.9%
Male
19
  43.2%
7
  43.8%
9
  19.6%
5
  38.5%
1
  20.0%
12
  52.2%
53
  36.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 44 participants 16 participants 46 participants 13 participants 5 participants 23 participants 147 participants
United States 44 15 46 13 5 23 146
Italy 0 1 0 0 0 0 1
1.Primary Outcome
Title Overall Response Rate Measured by Complete Response (CR) Rate and Partial Response (PR) Rate as Determined by RECIST
Hide Description A 5% response rate is considered not promising, a 20% response rate is considered promising. For each stratum, the response rate will be estimated and a confidence interval will be constructed.
Time Frame Up to 4 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Angiosarcoma MPNST Leiomyosarcoma Undifferentiated Pleomorphic Sarcoma Fibrosarcoma Other Histology
Hide Arm/Group Description:
Sorafenib 400 mg PO BID
Sorafenib 400 mg PO BID
Sorafenib 400 mg PO BID
Sorafenib 400 mg PO BID
Sorafenib 400 mg PO BID
Sorafenib 400 mg PO BID
Overall Number of Participants Analyzed 37 12 39 10 5 19
Measure Type: Number
Unit of Measure: participants
Complete Response 1 0 0 0 0 0
Partial Response 4 0 1 0 0 0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Angiosarcoma MPNST Leiomyosarcoma Undifferentiated Pleomorphic Sarcoma Fibrosarcoma Other Histology
Hide Arm/Group Description Sorafenib 400 mg PO BID Sorafenib 400 mg PO BID Sorafenib 400 mg PO BID Sorafenib 400 mg PO BID Sorafenib 400 mg PO BID Sorafenib 400 mg PO BID
All-Cause Mortality
Angiosarcoma MPNST Leiomyosarcoma Undifferentiated Pleomorphic Sarcoma Fibrosarcoma Other Histology
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Angiosarcoma MPNST Leiomyosarcoma Undifferentiated Pleomorphic Sarcoma Fibrosarcoma Other Histology
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   13/44 (29.55%)      7/16 (43.75%)      7/46 (15.22%)      9/13 (69.23%)      0/5 (0.00%)      5/23 (21.74%)    
Blood and lymphatic system disorders             
Hemoglobin decreased (Anemia)  1  0/44 (0.00%)  0 0/16 (0.00%)  0 1/46 (2.17%)  1 0/13 (0.00%)  0 0/5 (0.00%)  0 0/23 (0.00%)  0
Cardiac disorders             
Cardiac disorder  1  2/44 (4.55%)  2 0/16 (0.00%)  0 0/46 (0.00%)  0 0/13 (0.00%)  0 0/5 (0.00%)  0 0/23 (0.00%)  0
Left ventricular systolic dysfunction  1  1/44 (2.27%)  1 0/16 (0.00%)  0 0/46 (0.00%)  0 0/13 (0.00%)  0 0/5 (0.00%)  0 0/23 (0.00%)  0
Atrial fibrillation  1  0/44 (0.00%)  0 0/16 (0.00%)  0 1/46 (2.17%)  1 0/13 (0.00%)  0 0/5 (0.00%)  0 0/23 (0.00%)  0
Left ventricular diastolic dysfunction  1  0/44 (0.00%)  0 0/16 (0.00%)  0 1/46 (2.17%)  1 0/13 (0.00%)  0 0/5 (0.00%)  0 0/23 (0.00%)  0
Eye disorders             
Vision-flashing lights  1  0/44 (0.00%)  0 0/16 (0.00%)  0 1/46 (2.17%)  1 0/13 (0.00%)  0 0/5 (0.00%)  0 0/23 (0.00%)  0
Gastrointestinal disorders             
Upper gastrointestinal hemorrhage  1  1/44 (2.27%)  1 0/16 (0.00%)  0 0/46 (0.00%)  0 0/13 (0.00%)  0 0/5 (0.00%)  0 0/23 (0.00%)  0
Small intestinal perforation  1  1/44 (2.27%)  1 0/16 (0.00%)  0 0/46 (0.00%)  0 0/13 (0.00%)  0 0/5 (0.00%)  0 0/23 (0.00%)  0
Small intestinal obstruction  1  0/44 (0.00%)  0 1/16 (6.25%)  1 1/46 (2.17%)  1 0/13 (0.00%)  0 0/5 (0.00%)  0 0/23 (0.00%)  0
Ileal perforation  1  0/44 (0.00%)  0 1/16 (6.25%)  1 0/46 (0.00%)  0 0/13 (0.00%)  0 0/5 (0.00%)  0 0/23 (0.00%)  0
Vomiting  1  0/44 (0.00%)  0 1/16 (6.25%)  1 1/46 (2.17%)  1 0/13 (0.00%)  0 0/5 (0.00%)  0 0/23 (0.00%)  0
Constipation  1  0/44 (0.00%)  0 0/16 (0.00%)  0 1/46 (2.17%)  1 1/13 (7.69%)  1 0/5 (0.00%)  0 0/23 (0.00%)  0
Diarrhea  1  0/44 (0.00%)  0 0/16 (0.00%)  0 1/46 (2.17%)  1 0/13 (0.00%)  0 0/5 (0.00%)  0 1/23 (4.35%)  1
Abdominal pain  1  0/44 (0.00%)  0 0/16 (0.00%)  0 1/46 (2.17%)  1 0/13 (0.00%)  0 0/5 (0.00%)  0 0/23 (0.00%)  0
Colitis  1  0/44 (0.00%)  0 0/16 (0.00%)  0 0/46 (0.00%)  0 1/13 (7.69%)  1 0/5 (0.00%)  0 0/23 (0.00%)  0
General disorders             
Death-Disease progression  1  1/1 (100.00%)  1 1/16 (6.25%)  1 1/46 (2.17%)  1 1/13 (7.69%)  1 0/5 (0.00%)  0 0/23 (0.00%)  0
Non-cardiac chest pain  1  2/44 (4.55%)  2 0/16 (0.00%)  0 0/46 (0.00%)  0 0/13 (0.00%)  0 0/5 (0.00%)  0 1/23 (4.35%)  1
Fatigue  1  0/44 (0.00%)  0 1/16 (6.25%)  1 1/46 (2.17%)  1 1/13 (7.69%)  1 0/5 (0.00%)  0 2/23 (8.70%)  2
Fever  1  0/44 (0.00%)  0 0/16 (0.00%)  0 1/46 (2.17%)  1 0/13 (0.00%)  0 0/5 (0.00%)  0 1/23 (4.35%)  1
General symptom, other-Failure to thrive  1  0/44 (0.00%)  0 0/16 (0.00%)  0 0/46 (0.00%)  0 1/13 (7.69%)  1 0/5 (0.00%)  0 0/23 (0.00%)  0
Death, NOS  1  0/44 (0.00%)  0 0/16 (0.00%)  0 0/46 (0.00%)  0 1/13 (7.69%)  1 0/5 (0.00%)  0 1/23 (4.35%)  1
Infections and infestations             
Bladder infection  1  0/44 (0.00%)  0 0/16 (0.00%)  0 0/46 (0.00%)  0 1/13 (7.69%)  1 0/5 (0.00%)  0 0/23 (0.00%)  0
Investigations             
Lymphocyte count decreased  1  1/44 (2.27%)  1 0/16 (0.00%)  0 0/46 (0.00%)  0 0/13 (0.00%)  0 0/5 (0.00%)  0 0/23 (0.00%)  0
Alanine aminotransferase increased  1  0/44 (0.00%)  0 0/16 (0.00%)  0 1/46 (2.17%)  1 0/13 (0.00%)  0 0/5 (0.00%)  0 0/23 (0.00%)  0
Aspartate aminotransferase increased  1  0/44 (0.00%)  0 0/16 (0.00%)  0 0/46 (0.00%)  0 0/13 (0.00%)  0 0/5 (0.00%)  0 0/23 (0.00%)  0
Alkaline phosphatase increased  1  0/44 (0.00%)  0 0/16 (0.00%)  0 2/46 (4.35%)  2 0/13 (0.00%)  0 0/5 (0.00%)  0 0/23 (0.00%)  0
Blood Bilirubin increased  1  0/44 (0.00%)  0 0/16 (0.00%)  0 1/46 (2.17%)  1 1/13 (7.69%)  1 0/5 (0.00%)  0 0/23 (0.00%)  0
Cardiac troponin T increased  1  0/44 (0.00%)  0 0/16 (0.00%)  0 0/46 (0.00%)  0 1/13 (7.69%)  1 0/5 (0.00%)  0 0/23 (0.00%)  0
Metabolism and nutrition disorders             
Hyponatremia  1  1/44 (2.27%)  1 0/16 (0.00%)  0 0/46 (0.00%)  0 0/13 (0.00%)  0 0/5 (0.00%)  0 0/23 (0.00%)  0
Dehydration  1  0/44 (0.00%)  0 0/16 (0.00%)  0 1/46 (2.17%)  1 1/13 (7.69%)  1 0/5 (0.00%)  0 0/23 (0.00%)  0
Anorexia  1  0/44 (0.00%)  0 0/16 (0.00%)  0 0/46 (0.00%)  0 1/13 (7.69%)  1 0/5 (0.00%)  0 0/23 (0.00%)  0
Musculoskeletal and connective tissue disorders             
Back pain  1  2/44 (4.55%)  2 0/16 (0.00%)  0 0/46 (0.00%)  0 0/13 (0.00%)  0 0/5 (0.00%)  0 0/23 (0.00%)  0
Myalgia  1  1/44 (2.27%)  1 0/16 (0.00%)  0 0/46 (0.00%)  0 0/13 (0.00%)  0 0/5 (0.00%)  0 0/23 (0.00%)  0
Neck pain  1  0/44 (0.00%)  0 1/16 (6.25%)  1 0/46 (0.00%)  0 0/13 (0.00%)  0 0/5 (0.00%)  0 0/23 (0.00%)  0
Nervous system disorders             
Ischemia cerebrovascular  1  1/44 (2.27%)  1 1/16 (6.25%)  1 0/46 (0.00%)  0 0/13 (0.00%)  0 0/5 (0.00%)  0 0/23 (0.00%)  0
Peripheral motor neuropathy  1  1/44 (2.27%)  1 0/16 (0.00%)  0 0/46 (0.00%)  0 0/13 (0.00%)  0 0/5 (0.00%)  0 0/23 (0.00%)  0
Peripheral sensory neuropathy  1  0/44 (0.00%)  0 1/16 (6.25%)  1 0/46 (0.00%)  0 0/13 (0.00%)  0 0/5 (0.00%)  0 0/23 (0.00%)  0
Intracranial hemorrhage  1  0/44 (0.00%)  0 0/16 (0.00%)  0 1/46 (2.17%)  1 0/13 (0.00%)  0 0/5 (0.00%)  0 0/23 (0.00%)  0
Psychiatric disorders             
Confusion  1  1/44 (2.27%)  1 0/16 (0.00%)  0 0/46 (0.00%)  0 0/13 (0.00%)  0 0/5 (0.00%)  0 0/23 (0.00%)  0
Respiratory, thoracic and mediastinal disorders             
Cough  1  1/44 (2.27%)  1 0/16 (0.00%)  0 0/46 (0.00%)  0 0/13 (0.00%)  0 0/5 (0.00%)  0 0/23 (0.00%)  0
Dyspnea  1  1/44 (2.27%)  1 0/16 (0.00%)  0 0/46 (0.00%)  0 1/13 (7.69%)  1 0/5 (0.00%)  0 0/23 (0.00%)  0
Pneumonitis  1  2/44 (4.55%)  2 0/16 (0.00%)  0 0/46 (0.00%)  0 0/13 (0.00%)  0 0/5 (0.00%)  0 0/23 (0.00%)  0
Pneumothorax  1  1/44 (2.27%)  1 0/16 (0.00%)  0 0/46 (0.00%)  0 0/13 (0.00%)  0 0/5 (0.00%)  0 0/23 (0.00%)  0
Bronchopulmonary hemorrhage  1  0/44 (0.00%)  0 1/16 (6.25%)  1 0/46 (0.00%)  0 0/13 (0.00%)  0 0/5 (0.00%)  0 0/23 (0.00%)  0
Hemorrhage, Respiratory tract (NOS)  1  0/44 (0.00%)  0 0/16 (0.00%)  0 0/46 (0.00%)  0 1/13 (7.69%)  1 0/5 (0.00%)  0 2/23 (8.70%)  2
Hemorrhage, bleeding other-Chest wall  1  0/44 (0.00%)  0 0/16 (0.00%)  0 0/46 (0.00%)  0 1/13 (7.69%)  1 0/5 (0.00%)  0 0/23 (0.00%)  0
Skin and subcutaneous tissue disorders             
Pruritus  1  1/44 (2.27%)  1 0/16 (0.00%)  0 0/46 (0.00%)  0 0/13 (0.00%)  0 0/5 (0.00%)  0 0/23 (0.00%)  0
Palmar-plantar erythrodysesthesia syndrome  1  1/44 (2.27%)  1 0/16 (0.00%)  0 1/46 (2.17%)  1 0/13 (0.00%)  0 0/5 (0.00%)  0 1/23 (4.35%)  1
Vascular disorders             
Hypertension  1  1/44 (2.27%)  1 0/16 (0.00%)  0 0/46 (0.00%)  0 0/13 (0.00%)  0 0/5 (0.00%)  0 0/23 (0.00%)  0
Thrombosis  1  0/44 (0.00%)  0 0/16 (0.00%)  0 1/46 (2.17%)  1 2/13 (15.38%)  2 0/5 (0.00%)  0 0/23 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE v.3.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Angiosarcoma MPNST Leiomyosarcoma Undifferentiated Pleomorphic Sarcoma Fibrosarcoma Other Histology
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   36/44 (81.82%)      12/16 (75.00%)      40/46 (86.96%)      10/13 (76.92%)      4/5 (80.00%)      21/23 (91.30%)    
Blood and lymphatic system disorders             
Anemia  1  10/44 (22.73%)  10 3/16 (18.75%)  3 2/46 (4.35%)  24 3/13 (23.08%)  3 1/5 (20.00%)  1 4/23 (17.39%)  4
Eye disorders             
Eyelid function disorder  1  0/44 (0.00%)  0 0/16 (0.00%)  0 0/46 (0.00%)  0 1/13 (7.69%)  1 0/5 (0.00%)  0 0/23 (0.00%)  0
Gastrointestinal disorders             
Constipation  1  2/44 (4.55%)  2 0/16 (0.00%)  0 0/46 (0.00%)  0 0/13 (0.00%)  0 0/5 (0.00%)  0 0/23 (0.00%)  0
Diarrhea  1  3/44 (6.82%)  3 0/16 (0.00%)  0 0/46 (0.00%)  0 1/13 (7.69%)  1 1/5 (20.00%)  1 3/23 (13.04%)  3
Nausea  1  2/44 (4.55%)  2 2/16 (12.50%)  2 0/46 (0.00%)  0 0/13 (0.00%)  0 0/5 (0.00%)  0 0/23 (0.00%)  0
Vomiting  1  3/44 (6.82%)  3 0/16 (0.00%)  0 2/46 (4.35%)  2 0/13 (0.00%)  0 0/5 (0.00%)  0 0/23 (0.00%)  0
Abdominal pain  1  0/44 (0.00%)  0 0/16 (0.00%)  0 0/46 (0.00%)  0 1/13 (7.69%)  1 0/5 (0.00%)  0 0/23 (0.00%)  0
Abdominal distension  1  0/44 (0.00%)  0 0/16 (0.00%)  0 0/46 (0.00%)  0 0/13 (0.00%)  0 1/5 (20.00%)  1 0/23 (0.00%)  0
Flatulence  1  0/44 (0.00%)  0 0/16 (0.00%)  0 0/46 (0.00%)  0 0/13 (0.00%)  0 1/5 (20.00%)  1 0/23 (0.00%)  0
Gingival pain  1  0/44 (0.00%)  0 0/16 (0.00%)  0 0/46 (0.00%)  0 0/13 (0.00%)  0 1/5 (20.00%)  1 0/23 (0.00%)  0
General disorders             
Fatigue  1  11/44 (25.00%)  11 0/16 (0.00%)  0 4/46 (8.70%)  4 0/13 (0.00%)  0 1/5 (20.00%)  1 4/23 (17.39%)  4
Fever  1  0/44 (0.00%)  0 0/16 (0.00%)  0 3/46 (6.52%)  3 0/13 (0.00%)  0 0/5 (0.00%)  0 0/23 (0.00%)  0
Edema limbs  1  0/44 (0.00%)  0 0/16 (0.00%)  0 0/46 (0.00%)  0 0/13 (0.00%)  0 1/5 (20.00%)  1 0/23 (0.00%)  0
Injury, poisoning and procedural complications             
Wound complication, non-infectious  1  0/44 (0.00%)  0 1/16 (6.25%)  1 0/46 (0.00%)  0 0/13 (0.00%)  0 0/5 (0.00%)  0 0/23 (0.00%)  0
Investigations             
Alanine aminotransferase increased  1  3/44 (6.82%)  3 1/16 (6.25%)  1 5/46 (10.87%)  5 2/13 (15.38%)  2 1/5 (20.00%)  1 1/23 (4.35%)  1
Aspartate aminotransferase increased  1  3/44 (6.82%)  3 1/16 (6.25%)  1 4/46 (8.70%)  4 0/13 (0.00%)  0 1/5 (20.00%)  1 1/23 (4.35%)  1
Blood bilirubin increased  1  2/44 (4.55%)  2 1/16 (6.25%)  1 0/46 (0.00%)  0 0/13 (0.00%)  0 0/5 (0.00%)  0 2/23 (8.70%)  2
INR increased  1  2/44 (4.55%)  2 0/16 (0.00%)  0 0/46 (0.00%)  0 0/13 (0.00%)  0 0/5 (0.00%)  0 0/23 (0.00%)  0
White blood cell decreased  1  2/44 (4.55%)  2 1/16 (6.25%)  1 6/46 (13.04%)  6 2/13 (15.38%)  2 1/5 (20.00%)  1 4/23 (17.39%)  4
Lymphocyte count decreased  1  7/44 (15.91%)  7 2/16 (12.50%)  2 7/46 (15.22%)  7 4/13 (30.77%)  4 1/5 (20.00%)  1 3/23 (13.04%)  3
Neutrophil count decreased  1  0/44 (0.00%)  0 1/16 (6.25%)  1 2/46 (4.35%)  2 0/13 (0.00%)  0 1/5 (20.00%)  1 2/23 (8.70%)  2
Weight loss  1  0/44 (0.00%)  0 1/16 (6.25%)  1 0/46 (0.00%)  0 0/13 (0.00%)  0 0/5 (0.00%)  0 0/23 (0.00%)  0
Platelet count decreased  1  0/44 (0.00%)  0 0/16 (0.00%)  0 0/46 (0.00%)  0 0/13 (0.00%)  0 1/5 (20.00%)  1 0/23 (0.00%)  0
Metabolism and nutrition disorders             
Hypoalbuminemia  1  5/44 (11.36%)  5 5/16 (31.25%)  5 2/46 (4.35%)  2 3/13 (23.08%)  3 1/5 (20.00%)  1 3/23 (13.04%)  3
Hyperglycemia  1  2/44 (4.55%)  2 3/16 (18.75%)  3 7/46 (15.22%)  7 3/13 (23.08%)  3 0/5 (0.00%)  0 2/23 (8.70%)  2
Hypophosphatemia  1  12/44 (27.27%)  12 1/16 (6.25%)  1 7/46 (15.22%)  7 2/13 (15.38%)  2 0/5 (0.00%)  0 9/23 (39.13%)  9
Hyperkalemia  1  2/44 (4.55%)  2 0/16 (0.00%)  0 0/46 (0.00%)  0 1/13 (7.69%)  1 0/5 (0.00%)  0 0/23 (0.00%)  0
Hypokalemia  1  2/44 (4.55%)  2 0/16 (0.00%)  0 0/46 (0.00%)  0 0/13 (0.00%)  0 1/5 (20.00%)  1 0/23 (0.00%)  0
Hypocalcemia  1  0/44 (0.00%)  0 3/16 (18.75%)  3 3/46 (6.52%)  3 2/13 (15.38%)  2 1/5 (20.00%)  1 1/23 (4.35%)  1
Hypomagnesemia  1  0/44 (0.00%)  0 1/16 (6.25%)  1 0/46 (0.00%)  0 0/13 (0.00%)  0 0/5 (0.00%)  0 0/23 (0.00%)  0
Anorexia  1  0/44 (0.00%)  0 0/16 (0.00%)  0 3/46 (6.52%)  3 1/13 (7.69%)  1 1/5 (20.00%)  1 0/23 (0.00%)  0
Hypoglycemia  1  0/44 (0.00%)  0 0/16 (0.00%)  0 0/46 (0.00%)  0 2/13 (15.38%)  2 0/5 (0.00%)  0 0/23 (0.00%)  0
Hyponatremia  1  0/44 (0.00%)  0 0/16 (0.00%)  0 0/46 (0.00%)  0 1/13 (7.69%)  1 0/5 (0.00%)  0 0/23 (0.00%)  0
Musculoskeletal and connective tissue disorders             
Pain in extremity  1  3/44 (6.82%)  3 0/16 (0.00%)  0 4/46 (8.70%)  4 2/13 (15.38%)  2 2/5 (40.00%)  2 0/23 (0.00%)  0
Joint range of motion decrease  1  0/44 (0.00%)  0 0/16 (0.00%)  0 0/46 (0.00%)  0 0/13 (0.00%)  0 1/5 (20.00%)  1 0/23 (0.00%)  0
Arthralgia  1  0/44 (0.00%)  0 0/16 (0.00%)  0 0/46 (0.00%)  0 0/13 (0.00%)  0 1/5 (20.00%)  1 0/23 (0.00%)  0
Nervous system disorders             
Peripheral sensory neuropathy  1  2/44 (4.55%)  2 0/16 (0.00%)  0 0/46 (0.00%)  0 1/13 (7.69%)  1 0/5 (0.00%)  0 0/23 (0.00%)  0
Psychiatric disorders             
Anxiety  1  0/44 (0.00%)  0 0/16 (0.00%)  0 0/46 (0.00%)  0 1/13 (7.69%)  1 0/5 (0.00%)  0 0/23 (0.00%)  0
Insomnia  1  0/44 (0.00%)  0 0/16 (0.00%)  0 0/46 (0.00%)  0 0/13 (0.00%)  0 1/5 (20.00%)  1 0/23 (0.00%)  0
Renal and urinary disorders             
Renal/Genitourinary-Other  1  0/44 (0.00%)  0 0/16 (0.00%)  0 0/46 (0.00%)  0 1/13 (7.69%)  1 0/5 (0.00%)  0 0/23 (0.00%)  0
Respiratory, thoracic and mediastinal disorders             
Dyspnea  1  0/44 (0.00%)  0 0/16 (0.00%)  0 0/46 (0.00%)  0 1/13 (7.69%)  1 0/5 (0.00%)  0 0/23 (0.00%)  0
Skin and subcutaneous tissue disorders             
Pruritus  1  3/44 (6.82%)  3 0/16 (0.00%)  0 0/46 (0.00%)  0 0/13 (0.00%)  0 1/5 (20.00%)  1 0/23 (0.00%)  0
Rash  1  10/44 (22.73%)  10 0/16 (0.00%)  0 12/46 (26.09%)  12 2/13 (15.38%)  2 3/5 (60.00%)  3 3/23 (13.04%)  3
Palmar-plantar erythrodysesthesia syndrome  1  15/44 (34.09%)  15 5/16 (31.25%)  5 17/46 (36.96%)  17 2/13 (15.38%)  2 3/5 (60.00%)  3 6/23 (26.09%)  6
Alopecia  1  0/44 (0.00%)  0 1/16 (6.25%)  1 2/46 (4.35%)  2 0/13 (0.00%)  0 0/5 (0.00%)  0 0/23 (0.00%)  0
Scalp pain  1  0/44 (0.00%)  0 0/16 (0.00%)  0 0/46 (0.00%)  0 0/13 (0.00%)  0 1/5 (20.00%)  1 0/23 (0.00%)  0
Vascular disorders             
Hypertension  1  8/44 (18.18%)  8 0/16 (0.00%)  0 4/46 (8.70%)  4 1/13 (7.69%)  1 0/5 (0.00%)  0 2/23 (8.70%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
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.
Results Point of Contact
Name/Title: Dr. William Tap
Organization: Memorial Sloan-Kettering Cancer Center
Phone: 646-888-4163
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00245102     History of Changes
Other Study ID Numbers: NCI-2012-01469
NCI-2012-01469 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
NCI-7060
CDR0000449962
MSKCC-05081
05-081 ( Other Identifier: Memorial Sloan-Kettering Cancer Center )
7060 ( Other Identifier: CTEP )
N01CM62206 ( U.S. NIH Grant/Contract )
P30CA008748 ( U.S. NIH Grant/Contract )
N01CM62201 ( U.S. NIH Grant/Contract )
First Submitted: October 25, 2005
First Posted: October 27, 2005
Results First Submitted: November 19, 2013
Results First Posted: January 20, 2014
Last Update Posted: May 23, 2014