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| Name | Class |
|---|---|
| Bayer | INDUSTRY |
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The purpose of this study is to find out what effects, good and/or bad, the combination of sorafenib and dacarbazine has on sarcoma. Recurrent sarcoma is difficult to treat. Standard chemotherapy drugs can be toxic, and the length of benefit is usually short. As a result, we need new treatments for sarcoma. Sorafenib is a new type of "targeted" chemotherapy that attacks specific proteins (including "raf" and "VEGF receptor") in cells. We hope that by blocking these proteins we can cause the tumor to shrink. Sorafenib is also known as BAY 43-9006 and by the trade name Nexavar®. The FDA approved sorafenib in December of 2005 to treat patients with kidney cancer and in November of 2007 to treat patients with liver cancer. This drug is not approved by the U.S. Food and Drug Administration (FDA) or any other licensing authority for the treatment of sarcoma and is therefore considered to be experimental in this setting.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sorafenib and Dacarbazine | Experimental | This study is an open label, single arm, Simon two stage, phase 2 trial of continuous, daily oral sorafenib, with intravenous dacarbazine administered every three weeks for patients with synovial sarcoma, leiomyosarcoma and malignant peripheral nerve sheath tumor. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sorafenib and Dacarbazine | Drug | Treatment will be administered on an outpatient basis. Sorafenib is supplied as 200-mg tablets. The starting dose of sorafenib will be 400 mg PO twice daily (every 12 hours) continuously. There is no planned treatment interruption between cycles. All patients will receive dacarbazine as an open-label dose of 850 mg/m2 by IV infusion over 60 minutes, starting on Week 1 and repeated every 3 weeks until disease progression or intolerance. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Objective Response | Response and progression 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) | at 18 weeks |
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Inclusion Criteria:
Hemoglobin ≥ 8.5 g/dl Absolute neutrophil count (ANC) ≥ 1,500/mm3 Platelet count ≥ 75,000/mm3 Total bilirubin < or = to 1.5 times ULN ALT and AST < or = to 2.5 times the ULN ( < or = to 5 x ULN for patients with liver involvement) Creatinine < or = to 1.5 times ULN
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 | Soft Tissue Sarcoma Patients | Sorafenib and Dacarbazine in Soft Tissue Sarcoma |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Soft Tissue Sarcoma Patients | Sorafenib and Dacarbazine in Soft Tissue Sarcoma |
| 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 | Response and progression 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 | at 18 weeks |
|
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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 | Soft Tissue Sarcoma Patients | Sorafenib and Dacarbazine in Soft Tissue Sarcoma |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death not associated w CTCAE term- Death NOS | General 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 |
| D013584 | Sarcoma, Synovial |
| D007890 | Leiomyosarcoma |
| D018319 | Neurofibrosarcoma |
| ID | Term |
|---|---|
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009372 | Neoplasms, Connective Tissue |
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| ID | Term |
|---|---|
| D000077157 | Sorafenib |
| D003606 | Dacarbazine |
| ID | Term |
|---|---|
| D010671 | Phenylurea Compounds |
| D014508 | Urea |
| D000577 | Amides |
| D009930 | Organic Chemicals |
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|
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
| 8 |
| 37 |
| 30 |
| 37 |
| Death not associated w CTCAE term-Disease progression NOS | General disorders | CTC-3.0 | Systematic Assessment |
|
| Fatigue (asthenia, lethargy, malaise) | General disorders | CTC-3.0 | Systematic Assessment |
|
| Hemoglobin | Blood and lymphatic system disorders | CTC-3.0 | Systematic Assessment |
|
| Hemorrhage/Bleeding, other | Blood and lymphatic system disorders | CTC-3.0 | Systematic Assessment |
|
| Leukocytes (total WBC) | Blood and lymphatic system disorders | CTC-3.0 | Systematic Assessment |
|
| Obstruction of airway-Bronchus | Respiratory, thoracic and mediastinal disorders | CTC-3.0 | Systematic Assessment |
|
| Pain - Extremity-limb | General disorders | CTC-3.0 | Systematic Assessment |
|
| Platelets | Blood and lymphatic system disorders | CTC-3.0 | Systematic Assessment |
|
| Sodium, low (hyponatremia) | Metabolism and nutrition disorders | CTC-3.0 | Systematic Assessment |
|
| Thrombosis/thrombus/embolism | Respiratory, thoracic and mediastinal disorders | CTC-3.0 | Systematic Assessment |
|
| Amylase | Metabolism and nutrition disorders | CTC-3.0 | Systematic Assessment |
|
| Creatinine | Metabolism and nutrition 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 |
|
| Hemoglobin | Blood and lymphatic system disorders | CTC-3.0 | Systematic Assessment |
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| Hypertension | Cardiac 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 |
|
| Neutrophils/granulocytes (ANC/AGC) | Blood and lymphatic system disorders | CTC-3.0 | Systematic Assessment |
|
| Phosphate, low (hypophosphatemia) | Metabolism and nutrition disorders | CTC-3.0 | Systematic Assessment |
|
| Platelets | Blood and lymphatic system disorders | CTC-3.0 | Systematic Assessment |
|
| Potassium, low (hypokalemia) | Investigations | CTC-3.0 | Systematic Assessment |
|
| Rash: hand-foot skin reaction | 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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| D009379 | Neoplasms, Muscle Tissue |
| D005354 | Fibrosarcoma |
| D018218 | Neoplasms, Fibrous Tissue |
| D009455 | Neurofibroma |
| D018317 | Nerve Sheath Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D010524 | Peripheral Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009422 | Nervous System Diseases |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D001555 |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009536 | Niacinamide |
| D009539 | Nicotinic Acids |
| D000147 | Acids, Heterocyclic |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D014226 | Triazenes |
| D007093 | Imidazoles |
| D001393 | Azoles |