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This is an open-label, single-arm, multicenter pilot study to evaluate the safety and efficacy of carboplatin/paclitaxel+bevacizumab in subjects with locally advanced (Stage IIIb with pleural effusion/pericardial effusion), Stage IV, or recurrent squamous Non-Small Cell Lung Cancer (NSCLC) who have not received prior systemic therapy for metastatic disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treated with Bevacizumab | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bevacizumab | Drug | 15 mg/kg administered intravenously on Day 1 of each 21- to 28-day cycle, beginning on Cycle 3 |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Grade ≥3 Pulmonary Hemorrhage Adverse Events | To estimate the rate of National Cancer Institute Common Terminology for Adverse Events (NCI CTCAE), Version 3.0, Grade ≥3 pulmonary hemorrhage adverse events. Per NCI CTCAE v.3: "Grade 3 = Transfusion, interventional radiology, endoscopic, or operative intervention indicated; radiation therapy (i.e., hemostasis of bleeding site); Grade 4 = Life-threatening consequences; major urgent intervention indicated; Grade 5 = Death." | First bevacizumab administration until 60 days after discontinuation of bevacizumab or death |
| Measure | Description | Time Frame |
|---|---|---|
| Selected Adverse Events | Selected treatment-emergent adverse events for any grade of pulmonary hemorrhage, any grade of non-pulmonary hemorrhage, any grade of gastrointestinal perforation, Grade ≥ 2 arterial thromboembolic events, Grade ≥ 2 left ventricular systolic dysfunction, Grade ≥ 3 proteinuria, and Grade ≥ 3 hypertension. Refer to NCI CTCAE v.3 for grading definitions. Serious adverse events (SAEs) occurring in any of the above categories are included. See the Serious Adverse Events section below for full SAE reporting. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Leonardo Faoro, M.D. | Genentech, Inc. | Study Director |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treated With Bevacizumab | Chemotherapy (carboplatin + paclitaxel) in combination with bevacizumab in intervals of chemotherapy alone (Cycles 1 and 2), chemotherapy + bevacizumab (Cycles 3-6), and bevacizumab alone (Cycles 7 and beyond). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Carboplatin | Drug | Dose based on Calvert formula, on Day 1 of each 21- to 28-day cycle for a total of 6 cycles |
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| Paclitaxel | Drug | Dose based on patient's body surface area, on Day 1 of each 21- to 28-day cycle for a total of 6 cycles |
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| First bevacizumab administration until 60 days after discontinuation of bevacizumab or death |
| Adverse Events That Led to Discontinuation of Bevacizumab | Any treatment-emergent adverse event leading to study treatment discontinuation | First bevacizumab administration until 60 days after discontinuation of bevacizumab or death |
| Progression-free Survival | Progression-free survival (PFS) was defined as the time from enrollment to the time of documented disease progression or death from any cause, whichever occurred earlier. PFS was determined for only those patients that received bevacizumab. Summary of PFS (median) was estimated from Kaplan-Meier curve. The 95% confidence interval (CI) for the median was computed using the method of Brookmeyer and Crowley. | Length of study |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Treated With Bevacizumab | Chemotherapy (carboplatin + paclitaxel) in combination with bevacizumab in intervals of chemotherapy alone (Cycles 1 and 2), chemotherapy + bevacizumab (Cycles 3-6), and bevacizumab alone (Cycles 7 and beyond). |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Of the 47 enrolled subjects, 31 met the protocol-specified criteria and received bevacizumab. | Mean | Standard Deviation | years |
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| Sex: Female, Male | Of the 47 enrolled subjects, 31 met the protocol-specified criteria and received bevacizumab. | Count of Participants | Participants |
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| 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 | Incidence of Grade ≥3 Pulmonary Hemorrhage Adverse Events | To estimate the rate of National Cancer Institute Common Terminology for Adverse Events (NCI CTCAE), Version 3.0, Grade ≥3 pulmonary hemorrhage adverse events. Per NCI CTCAE v.3: "Grade 3 = Transfusion, interventional radiology, endoscopic, or operative intervention indicated; radiation therapy (i.e., hemostasis of bleeding site); Grade 4 = Life-threatening consequences; major urgent intervention indicated; Grade 5 = Death." | Safety-evaluable patients | Posted | Number | Percentage of patients | First bevacizumab administration until 60 days after discontinuation of bevacizumab or death |
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| Secondary | Selected Adverse Events | Selected treatment-emergent adverse events for any grade of pulmonary hemorrhage, any grade of non-pulmonary hemorrhage, any grade of gastrointestinal perforation, Grade ≥ 2 arterial thromboembolic events, Grade ≥ 2 left ventricular systolic dysfunction, Grade ≥ 3 proteinuria, and Grade ≥ 3 hypertension. Refer to NCI CTCAE v.3 for grading definitions. Serious adverse events (SAEs) occurring in any of the above categories are included. See the Serious Adverse Events section below for full SAE reporting. | Safety-evaluable patients | Posted | Number | Patients | First bevacizumab administration until 60 days after discontinuation of bevacizumab or death |
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| Secondary | Adverse Events That Led to Discontinuation of Bevacizumab | Any treatment-emergent adverse event leading to study treatment discontinuation | Safety-evaluable patients | Posted | Number | Patients | First bevacizumab administration until 60 days after discontinuation of bevacizumab or death |
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| Secondary | Progression-free Survival | Progression-free survival (PFS) was defined as the time from enrollment to the time of documented disease progression or death from any cause, whichever occurred earlier. PFS was determined for only those patients that received bevacizumab. Summary of PFS (median) was estimated from Kaplan-Meier curve. The 95% confidence interval (CI) for the median was computed using the method of Brookmeyer and Crowley. | Enrolled patients | Posted | Median | 95% Confidence Interval | Months | Length of 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 | Treated With Bevacizumab | Chemotherapy (carboplatin + paclitaxel) in combination with bevacizumab in intervals of chemotherapy alone (Cycles 1 and 2), chemotherapy + bevacizumab (Cycles 3-6), and bevacizumab alone (Cycles 7 and beyond). | 18 | 31 | 12 | 31 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dyspnea | Respiratory, thoracic and mediastinal disorders |
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| Hemoptysis | Respiratory, thoracic and mediastinal disorders |
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| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders |
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| Pulmonary Hemorrhage | Respiratory, thoracic and mediastinal disorders |
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| Bronchitis | Infections and infestations |
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| Infection | Infections and infestations |
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| Pneumonia | Infections and infestations |
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| Basal Ganglia Infarction | Nervous system disorders |
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| Cerebral Infarction | Nervous system disorders |
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| Cerebral Ischemia | Nervous system disorders |
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| Deep Vein Thrombosis | Vascular disorders |
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| Hypotension | Vascular disorders |
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| Atrial Flutter | Cardiac disorders |
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| Cardiac Failure Congestive | Cardiac disorders |
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| Small Intestinal Obstruction | Gastrointestinal disorders |
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| Pain | General disorders |
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| Hip Fracture | Injury, poisoning and procedural complications |
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| Confusional State | Psychiatric disorders |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypertension | Vascular disorders |
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| Asthenia | General disorders |
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| Chest Pain | General disorders |
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| Chills | General disorders |
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| Fatigue | General disorders |
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| Pyrexia | General disorders |
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| Arthralgia | Musculoskeletal and connective tissue disorders |
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| Neuropathy Peripheral | Nervous system disorders |
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| Sinusitis | Infections and infestations |
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| Anorexia | Metabolism and nutrition disorders |
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| Proteinuria | Renal and urinary disorders |
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| Hemoptysis | Respiratory, thoracic and mediastinal disorders |
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The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Genentech, Inc. | 800-821-8590 |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| D016190 | Carboplatin |
| D017239 | Paclitaxel |
| ID | Term |
|---|---|
| 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 |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |
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