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| Name | Class |
|---|---|
| Dana-Farber Cancer Institute | OTHER |
| Celgene Corporation | INDUSTRY |
| Genentech, Inc. | INDUSTRY |
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The purpose of this research study is to learn more about whether the combination of drugs carboplatin, Abraxane and Avastin helps treat non-small cell lung cancer (NSCLC). One of the standard treatments for advanced NSCLC is the combination of the drugs carboplatin, paclitaxel and Avastin. Paclitaxel can be associated with severe side effects that may make the treatment difficult to tolerate. Some of these side effects are caused by the solution used to dissolve paclitaxel before it can be administered. Abraxane is a different form of paclitaxel that does not need to be dissolved by this solution. Abraxane is approved for the treatment of breast cancer but is not approved to treat NSCLC. We will also be trying to learn more about how the drug Avastin may work to treat cancer.
Participants can receive up to 6 cycles of carboplatin, Abraxane and Avastin if their disease does not get worse and they do not experience intolerable side effects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chemotherapy | Experimental | Carboplatin, nab-paclitaxel, and bevacizumab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| carboplatin | Drug | Given by infusion on day 1 of each 3 week cycle for a maximum of 6 cycles |
|
| Measure | Description | Time Frame |
|---|---|---|
| 6-month Progression Free Survival Rate | Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. | 6 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate to Carboplatin, Abraxane and Avastin | Objective response rate to carboplatin, Abraxane and Avastin according to Response Evaluation Criteria in Solid Tumors [Version 1.0] | 3 years |
| 6 Month Survival Rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rebecca Heist, MD MPH | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States | ||
| Dana-Farber Cancer Institute |
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| ID | Title | Description |
|---|---|---|
| FG000 | Chemotherapy | carboplatin: Given by infusion on day 1 of each 3 week cycle for a maximum of 6 cycles Abraxane: Given by infusion once weekly (days 1, 8 and 15) of each three week cycle for a maximum of 6 cycles Bevacizumab |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Chemotherapy | carboplatin: Given by infusion on day 1 of each 3 week cycle for a maximum of 6 cycles Abraxane: Given by infusion once weekly (days 1, 8 and 15) of each three week cycle for a maximum of 6 cycles Bevacizumab |
| 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 | 6-month Progression Free Survival Rate | Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. | Posted | Number | 95% Confidence Interval | percentage of participants | 6 Months |
|
|
Adverse events were collected throughout duration of study
Adverse events were evaluated on day 1 of cycle 1 and every three weeks prior to chemotherapy and prior to each Avastin dose. Adverse events were then assessed every three months after the completion of 6 cycles of carboplatin, Abraxane, and Avastin until tumor progression or withdrawal from study.
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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 | Chemotherapy | carboplatin: Given by infusion on day 1 of each 3 week cycle for a maximum of 6 cycles Abraxane: Given by infusion once weekly (days 1, 8 and 15) of each three week cycle for a maximum of 6 cycles Bevacizumab |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombosis/thrombus/embolism | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | CTCAE (3.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Rebecca Heist | Massachusetts General Hospital | 6177244000 | rheist@partners.org |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| D016190 | Carboplatin |
| C520255 | 130-nm albumin-bound paclitaxel |
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
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| Nab-paclitaxel | Drug | Given by infusion once weekly (days 1, 8 and 15) of each three week cycle for a maximum of 6 cycles |
|
| Bevacizumab | Drug | IV infusion |
|
The percentage of participants surviving at least six months after baseline
| 6 months |
| Overall Survival | The median overall survival in months | 3 years |
| Boston |
| Massachusetts |
| 02115 |
| United States |
| Participants |
|
| Age, Continuous | Median | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
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| Secondary | Objective Response Rate to Carboplatin, Abraxane and Avastin | Objective response rate to carboplatin, Abraxane and Avastin according to Response Evaluation Criteria in Solid Tumors [Version 1.0] | Posted | Count of Participants | Participants | 3 years |
|
|
|
| Secondary | 6 Month Survival Rate | The percentage of participants surviving at least six months after baseline | Posted | Number | 95% Confidence Interval | percentage of participants surviving | 6 months |
|
|
|
| Secondary | Overall Survival | The median overall survival in months | Posted | Median | 95% Confidence Interval | Months | 3 years |
|
|
|
| 0 |
| 36 |
| 7 |
| 36 |
| 36 |
| 36 |
| Neutrophils | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
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| Platelets | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
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| ALT - SGPT | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| ALT - SGOT | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Anorexia | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Dysgeusia | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| dehydration | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pain | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Neuropathy | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Infection | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Renal | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hypertension | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
|
| Thrombosis/thrombus/embolism | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
|
| GI bleeding | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Epistaxis | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
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| Proteinuria | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
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| White Blood Cell Count | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
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| Absolute Neutrophil count | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
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| Hemoglobin | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
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| Platelets | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| ALT, SGPT | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Alkaline phosphatase | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
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| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| Title | Measurements |
|---|---|
|
| Not Evaluable for Response |
|