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Trial record 6 of 66 for:    Sarcoma | "Dermatofibroma"

Gemcitabine and Docetaxel With Bevacizumab in Selected Sarcoma Subtypes

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ClinicalTrials.gov Identifier: NCT00887809
Recruitment Status : Completed
First Posted : April 24, 2009
Results First Posted : January 25, 2016
Last Update Posted : January 25, 2016
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Sarcoma
Leiomyosarcoma
Malignant Fibrous
Histiocytoma
Angiosarcoma
Interventions Drug: gemcitabine
Drug: docetaxel
Drug: bevacizumab
Enrollment 47
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Gemcitabine, Docetaxel, Bevacizumab Gemcitabine, Docetaxel, Placebo
Hide Arm/Group Description Gemcitabine, Docetaxel, Bevacizumab Gemcitabine, Docetaxel, Placebo
Period Title: Overall Study
Started 37 10
Completed 33 10
Not Completed 4 0
Reason Not Completed
Patient Not Treated             3             0
Death             1             0
Arm/Group Title Gemcitabine, Docetaxel, Bevacizumab Gemcitabine, Docetaxel, Placebo Total
Hide Arm/Group Description Gemcitabine, Docetaxel, Bevacizumab Gemcitabine, Docetaxel, Placebo Total of all reporting groups
Overall Number of Baseline Participants 37 10 47
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants 10 participants 47 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
26
  70.3%
7
  70.0%
33
  70.2%
>=65 years
11
  29.7%
3
  30.0%
14
  29.8%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants 10 participants 47 participants
Female
22
  59.5%
2
  20.0%
24
  51.1%
Male
15
  40.5%
8
  80.0%
23
  48.9%
1.Primary Outcome
Title Overall Objective Response
Hide Description Overall Objective Response will be evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1)
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Gemcitabine, Docetaxel, Bevacizumab Gemcitabine, Docetaxel, Placebo
Hide Arm/Group Description:
Gemcitabine, Docetaxel, Bevacizumab
Gemcitabine, Docetaxel, Placebo
Overall Number of Participants Analyzed 33 10
Measure Type: Number
Unit of Measure: participants
Complete Response (CR) 0 1
Partial Response (PR) 9 1
Stable Disease (SD) 23 7
Progression of Disease (POD) 1 1
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Gemcitabine, Docetaxel, Bevacizumab Gemcitabine, Docetaxel, Placebo
Hide Arm/Group Description Gemcitabine, Docetaxel, Bevacizumab Gemcitabine, Docetaxel, Placebo
All-Cause Mortality
Gemcitabine, Docetaxel, Bevacizumab Gemcitabine, Docetaxel, Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Gemcitabine, Docetaxel, Bevacizumab Gemcitabine, Docetaxel, Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   12/37 (32.43%)      6/10 (60.00%)    
Blood and lymphatic system disorders     
Hemoglobin  1  0/37 (0.00%)  0 2/10 (20.00%)  2
Hemorrhage/Bleeding, other  1  1/37 (2.70%)  1 0/10 (0.00%)  0
Leukocytes  1  0/37 (0.00%)  0 1/10 (10.00%)  1
Platelets  1  1/37 (2.70%)  1 2/10 (20.00%)  2
Cardiac disorders     
Cardiac ischemia/infarction  1  0/37 (0.00%)  0 1/10 (10.00%)  1
Hypertension  1  1/37 (2.70%)  1 0/10 (0.00%)  0
Valvular heart disease  1  1/37 (2.70%)  1 0/10 (0.00%)  0
Gastrointestinal disorders     
Colitis  1  0/37 (0.00%)  0 1/10 (10.00%)  1
General disorders     
Death not assoc w CTCAE term- Death NOS  1  1/37 (2.70%)  1 0/10 (0.00%)  0
Febrile neutropenia  1  0/37 (0.00%)  0 1/10 (10.00%)  1
Pain - Chest/thorax NOS  1  1/37 (2.70%)  1 0/10 (0.00%)  0
Pain - Extremity-limb  1  1/37 (2.70%)  1 0/10 (0.00%)  0
Pain - Pelvis  1  0/37 (0.00%)  0 2/10 (20.00%)  2
Syncope (fainting)  1  1/37 (2.70%)  1 0/10 (0.00%)  0
Infections and infestations     
Infection normal Absolute Neutrophil Counts/grade 1/2 neutrophils-Cellulitis(skin)  1  1/37 (2.70%)  1 0/10 (0.00%)  0
Infection normal Absolute Neutrophil Counts/grade 1/2 neutrophils-Pneumonia(lung)  1  1/37 (2.70%)  1 0/10 (0.00%)  0
Infection unknown Absolute Neutrophil Counts -Pneumonia(lung)  1  0/37 (0.00%)  0 1/10 (10.00%)  1
Infection, other  1  2/37 (5.41%)  2 0/10 (0.00%)  0
Nervous system disorders     
Confusion  1  0/37 (0.00%)  0 1/10 (10.00%)  1
Renal and urinary disorders     
Renal/Genitourinary-Other  1  0/37 (0.00%)  0 1/10 (10.00%)  1
Respiratory, thoracic and mediastinal disorders     
Dyspnea (shortness of breath)  1  0/37 (0.00%)  0 1/10 (10.00%)  1
Pulmonary/upper respiratory - Other  1  0/37 (0.00%)  0 1/10 (10.00%)  1
Pulmonary hypertension  1  1/37 (2.70%)  1 0/10 (0.00%)  0
Thrombosis/thrombus/embolism  1  1/37 (2.70%)  1 0/10 (0.00%)  0
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%
Gemcitabine, Docetaxel, Bevacizumab Gemcitabine, Docetaxel, Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   33/37 (89.19%)      10/10 (100.00%)    
Blood and lymphatic system disorders     
ALT, SGPT  1  10/37 (27.03%)  10 3/10 (30.00%)  3
AST, SGOT  1  10/37 (27.03%)  10 0/10 (0.00%)  0
Hemoglobin  1  27/37 (72.97%)  27 8/10 (80.00%)  8
International normalized ratio (INR)  1  0/37 (0.00%)  0 1/10 (10.00%)  1
Leukocytes (total WBC)  1  20/37 (54.05%)  20 5/10 (50.00%)  5
Lymphopenia  1  16/37 (43.24%)  16 6/10 (60.00%)  6
Neutrophils/granulocytes  1  22/37 (59.46%)  22 5/10 (50.00%)  5
Platelets  1  9/37 (24.32%)  9 3/10 (30.00%)  3
Partial thromboplastin time (PTT)  1  0/37 (0.00%)  0 1/10 (10.00%)  1
General disorders     
Edema: limb  1  3/37 (8.11%)  3 1/10 (10.00%)  1
Fatigue (asthenia, lethargy, malaise)  1  3/37 (8.11%)  3 2/10 (20.00%)  2
Mucositis (Clincal exam)- Oral cavity  1  3/37 (8.11%)  3 0/10 (0.00%)  0
Infections and infestations     
Infection normal Absolute Neutrophil Counts/grade 1/2 neutrophils-Pneumonia(lung)  1  0/37 (0.00%)  0 1/10 (10.00%)  1
Metabolism and nutrition disorders     
Albumin, low (hypoalbuminemia)  1  19/37 (51.35%)  19 6/10 (60.00%)  6
Alkaline phosphatase  1  5/37 (13.51%)  5 1/10 (10.00%)  1
Bilirubin (hyperbilirubinemia)  1  3/37 (8.11%)  3 1/10 (10.00%)  1
Creatinine  1  0/37 (0.00%)  0 1/10 (10.00%)  1
Glucose, high (hyperglycemia)  1  17/37 (45.95%)  17 4/10 (40.00%)  4
Glucose, low (hypoglycemia)  1  3/37 (8.11%)  3 0/10 (0.00%)  0
Magnesium, high (hypermagnesemia)  1  2/37 (5.41%)  2 0/10 (0.00%)  0
Phosphate, low (hypophosphatemia)  1  11/37 (29.73%)  11 3/10 (30.00%)  3
Potassium, high (hyperkalemia)  1  3/37 (8.11%)  3 1/10 (10.00%)  1
Potassium, low (hypokalemia)  1  4/37 (10.81%)  4 2/10 (20.00%)  2
Sodium, low (hyponatremia)  1  2/37 (5.41%)  2 2/10 (20.00%)  2
Respiratory, thoracic and mediastinal disorders     
Dyspnea (shortness of breath)  1  0/37 (0.00%)  0 1/10 (10.00%)  1
Skin and subcutaneous tissue disorders     
Rash: erythema multiforme  1  0/37 (0.00%)  0 1/10 (10.00%)  1
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. William Tap
Organization: Memorial Sloan Kettering Cancer Center
Phone: 646-888-4163
Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00887809     History of Changes
Other Study ID Numbers: 09-015
First Submitted: April 23, 2009
First Posted: April 24, 2009
Results First Submitted: December 21, 2015
Results First Posted: January 25, 2016
Last Update Posted: January 25, 2016