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| Name | Class |
|---|---|
| Genentech, Inc. | INDUSTRY |
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The purpose of this study is to test whether an experimental drug called bevacizumab given together with gemcitabine and docetaxel, a standard chemotherapy regimen for sarcoma, can help sarcoma patients. This trial will examine what effects, good and/or bad the combination of gemcitabine, docetaxel and bevacizumab has on sarcoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| gemcitabine and docetaxel with bevacizumab | Experimental | Patients will receive bevacizumab at 15 mg/kg on day 1 of each 21-day cycle intravenously over 30 minutes followed by a one hour (+30/-15 min) break. For cycles 1 through 6, gemcitabine will be administered at 900 mg/m2 over 90 minutes on day 1 and 8 of a 21-day cycle. Docetaxel will be administered at 75 mg/m2, over 60 minutes, on day 8. This will be followed by either 5 days of filgrastim or a single injection of pegfilgrastim. For cycles 7 and beyond, gemcitabine will be given at 800 mg/m2 over 30 minutes on day 1 and 8; docetaxel will be given at 35 mg/m2 over 30 minutes, also on days 1 and 8. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| gemcitabine | Drug |
| ||
| docetaxel |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Objective Response | 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) | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| William Tap, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10065 | United States |
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| Label | URL |
|---|---|
| Memorial Sloan-Kettering Cancer Center | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Gemcitabine, Docetaxel, Bevacizumab | Gemcitabine, Docetaxel, Bevacizumab |
| FG001 | Gemcitabine, Docetaxel, Placebo | Gemcitabine, Docetaxel, Placebo |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Gemcitabine, Docetaxel, Bevacizumab | Gemcitabine, Docetaxel, Bevacizumab |
| BG001 | Gemcitabine, Docetaxel, Placebo | Gemcitabine, Docetaxel, Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Overall Objective Response | 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) | Posted | Number | participants | 6 months |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Gemcitabine, Docetaxel, Bevacizumab | Gemcitabine, Docetaxel, Bevacizumab |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac ischemia/infarction | Cardiac disorders | CTC-3.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Albumin, low (hypoalbuminemia) | Metabolism and nutrition disorders | CTC-3.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. William Tap | Memorial Sloan Kettering Cancer Center | 646-888-4163 | tapw@mskcc.org |
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| ID | Term |
|---|---|
| D012509 | Sarcoma |
| D007890 | Leiomyosarcoma |
| D051642 | Histiocytoma |
| D006394 | Hemangiosarcoma |
| ID | Term |
|---|---|
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009379 | Neoplasms, Muscle Tissue |
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| ID | Term |
|---|---|
| D000093542 | Gemcitabine |
| D000077143 | Docetaxel |
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
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|
| bevacizumab | Drug |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Counts |
|---|
| Participants |
|
|
| 12 |
| 37 |
| 33 |
| 37 |
| EG001 | Gemcitabine, Docetaxel, Placebo | Gemcitabine, Docetaxel, Placebo | 6 | 10 | 10 | 10 |
| Colitis | Gastrointestinal disorders | CTC-3.0 | Systematic Assessment |
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| Confusion | Nervous system disorders | CTC-3.0 | Systematic Assessment |
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| Death not assoc w CTCAE term- Death NOS | General disorders | CTC-3.0 | Systematic Assessment |
|
| Dyspnea (shortness of breath) | Respiratory, thoracic and mediastinal disorders | CTC-3.0 | Systematic Assessment |
|
| Febrile neutropenia | General disorders | CTC-3.0 | Systematic Assessment |
|
| Hemoglobin | Blood and lymphatic system disorders | CTC-3.0 | Systematic Assessment |
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| Hemorrhage/Bleeding, other | Blood and lymphatic system disorders | CTC-3.0 | Systematic Assessment |
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| Hypertension | Cardiac disorders | CTC-3.0 | Systematic Assessment |
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| Infection normal Absolute Neutrophil Counts/grade 1/2 neutrophils-Cellulitis(skin) | Infections and infestations | CTC-3.0 | Systematic Assessment |
|
| Infection normal Absolute Neutrophil Counts/grade 1/2 neutrophils-Pneumonia(lung) | Infections and infestations | CTC-3.0 | Systematic Assessment |
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| Infection unknown Absolute Neutrophil Counts -Pneumonia(lung) | Infections and infestations | CTC-3.0 | Systematic Assessment |
|
| Infection, other | Infections and infestations | CTC-3.0 | Systematic Assessment |
|
| Leukocytes | Blood and lymphatic system disorders | CTC-3.0 | Systematic Assessment |
|
| Pain - Chest/thorax NOS | General disorders | CTC-3.0 | Systematic Assessment |
|
| Pain - Extremity-limb | General disorders | CTC-3.0 | Systematic Assessment |
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| Pain - Pelvis | General disorders | CTC-3.0 | Systematic Assessment |
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| Platelets | Blood and lymphatic system disorders | CTC-3.0 | Systematic Assessment |
|
| Pulmonary/upper respiratory - Other | Respiratory, thoracic and mediastinal disorders | CTC-3.0 | Systematic Assessment |
|
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | CTC-3.0 | Systematic Assessment |
|
| Renal/Genitourinary-Other | Renal and urinary disorders | CTC-3.0 | Systematic Assessment |
|
| Syncope (fainting) | General disorders | CTC-3.0 | Systematic Assessment |
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| Thrombosis/thrombus/embolism | Respiratory, thoracic and mediastinal disorders | CTC-3.0 | Systematic Assessment |
|
| Valvular heart disease | Cardiac disorders | CTC-3.0 | Systematic Assessment |
|
| Alkaline phosphatase | Metabolism and nutrition disorders | CTC-3.0 | Systematic Assessment |
|
| ALT, SGPT | Blood and lymphatic system disorders | CTC-3.0 | Systematic Assessment |
|
| AST, SGOT | Blood and lymphatic system disorders | CTC-3.0 | Systematic Assessment |
|
| Bilirubin (hyperbilirubinemia) | Metabolism and nutrition disorders | CTC-3.0 | Systematic Assessment |
|
| Creatinine | Metabolism and nutrition disorders | CTC-3.0 | Systematic Assessment |
|
| Dyspnea (shortness of breath) | Respiratory, thoracic and mediastinal disorders | CTC-3.0 | Systematic Assessment |
|
| Edema: limb | General disorders | CTC-3.0 | Systematic Assessment |
|
| Fatigue (asthenia, lethargy, malaise) | General disorders | CTC-3.0 | Systematic Assessment |
|
| Glucose, high (hyperglycemia) | Metabolism and nutrition disorders | CTC-3.0 | Systematic Assessment |
|
| Glucose, low (hypoglycemia) | Metabolism and nutrition disorders | CTC-3.0 | Systematic Assessment |
|
| Hemoglobin | Blood and lymphatic system disorders | CTC-3.0 | Systematic Assessment |
|
| Infection normal Absolute Neutrophil Counts/grade 1/2 neutrophils-Pneumonia(lung) | Infections and infestations | CTC-3.0 | Systematic Assessment |
|
| International normalized ratio (INR) | Blood and lymphatic system disorders | CTC-3.0 | Systematic Assessment |
|
| Leukocytes (total WBC) | Blood and lymphatic system disorders | CTC-3.0 | Systematic Assessment |
|
| Lymphopenia | Blood and lymphatic system disorders | CTC-3.0 | Systematic Assessment |
|
| Magnesium, high (hypermagnesemia) | Metabolism and nutrition disorders | CTC-3.0 | Systematic Assessment |
|
| Mucositis (Clincal exam)- Oral cavity | General disorders | CTC-3.0 | Systematic Assessment |
|
| Neutrophils/granulocytes | Blood and lymphatic system disorders | CTC-3.0 | Systematic Assessment |
|
| Phosphate, low (hypophosphatemia) | Metabolism and nutrition disorders | CTC-3.0 | Systematic Assessment |
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| Platelets | Blood and lymphatic system disorders | CTC-3.0 | Systematic Assessment |
|
| Potassium, high (hyperkalemia) | Metabolism and nutrition disorders | CTC-3.0 | Systematic Assessment |
|
| Potassium, low (hypokalemia) | Metabolism and nutrition disorders | CTC-3.0 | Systematic Assessment |
|
| Partial thromboplastin time (PTT) | Blood and lymphatic system disorders | CTC-3.0 | Systematic Assessment |
|
| Rash: erythema multiforme | Skin and subcutaneous tissue disorders | CTC-3.0 | Systematic Assessment |
|
| Sodium, low (hyponatremia) | Metabolism and nutrition disorders | CTC-3.0 | Systematic Assessment |
|
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| D018218 | Neoplasms, Fibrous Tissue |
| D009372 | Neoplasms, Connective Tissue |
| D009383 | Neoplasms, Vascular Tissue |
| D011743 |
| Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |