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This is a placebo-controlled, double-blind, multicenter, randomized study for preliminary evaluation of the efficacy and safety of combining bevacizumab with cisplatin (or carboplatin) and etoposide in patients with previously untreated extensive-stage small cell lung cancer (SCLC).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo+Chemotherapy | Placebo Comparator | Chemotherapy = cisplatin (or carboplatin) + etoposide |
|
| Bevacizumab+Chemotherapy | Experimental | Chemotherapy = cisplatin (or carboplatin) + etoposide |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bevacizumab | Drug | Bevacizumab 15 mg/kg by intravenous (IV) infusion on Day 1 of each of the first four 21-day cycles during chemotherapy, followed by single agent administration until disease progression, unacceptable toxicity, discontinuation from study, or death. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival (PFS) | Duration of PFS, defined as the time from randomization to disease progression or on-study death, whichever occurred first. | Randomization until progression or lost to follow-up (up to 2 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Duration of overall survival from randomization until death or loss to follow-up | Randomization until death or lost of follow-up (up to 27 months) |
| Percentage of Participants With an Objective Response |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Karlin, M.D. | Genentech, Inc. | Study Director |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo+Chemotherapy | Chemotherapy = cisplatin (or carboplatin) + etoposide. Placebo 15 mg/kg by intravenous (IV) infusion on Day 1 of each of the first four 21-day cycles during chemotherapy, followed by single agent administration until disease progression, unacceptable toxicity, discontinuation from study, or death. Cisplatin 75 mg/m² IV on Day 1 of each of the first four 21-day cycles OR carboplatin (area under the curve [AUC]=5 mg/mL/min, per Calvert formula) IV on Day 1 of each of the first four 21-day cycles; etoposide 100 mg/m² on Days 1-3 of each of the first four 21-day cycles. |
| FG001 | Bevacizumab+Chemotherapy | Chemotherapy = cisplatin (or carboplatin) + etoposide. Bevacizumab 15 mg/kg by intravenous (IV) infusion on Day 1 of each of the first four 21-day cycles during chemotherapy, followed by single agent administration until disease progression, unacceptable toxicity, discontinuation from study, or death. Cisplatin 75 mg/m² IV on Day 1 of each of the first four 21-day cycles OR carboplatin (area under the curve [AUC]=5 mg/mL/min, per Calvert formula) IV on Day 1 of each of the first four 21-day cycles; etoposide 100 mg/m² on Days 1-3 of each of the first four 21-day cycles. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo+Chemotherapy | Chemotherapy = cisplatin (or carboplatin) + etoposide. Placebo 15 mg/kg by intravenous (IV) infusion on Day 1 of each of the first four 21-day cycles during chemotherapy, followed by single agent administration until disease progression, unacceptable toxicity, discontinuation from study, or death. Cisplatin 75 mg/m² IV on Day 1 of each of the first four 21-day cycles OR carboplatin (area under the curve [AUC]=5 mg/mL/min, per Calvert formula) IV on Day 1 of each of the first four 21-day cycles; etoposide 100 mg/m² on Days 1-3 of each of the first four 21-day cycles. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| 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 | Progression-free Survival (PFS) | Duration of PFS, defined as the time from randomization to disease progression or on-study death, whichever occurred first. | Intent-to-treat population | Posted | Median | 95% Confidence Interval | Months | Randomization until progression or lost to follow-up (up to 2 years) |
|
Overall duration of study
Safety analyses were performed on the safety evaluable population, which included 98 patients who received at least one dose of chemotherapy, bevacizumab, or placebo.
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
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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 | Placebo+Chemotherapy | Chemotherapy = cisplatin (or carboplatin) + etoposide. Placebo 15 mg/kg by intravenous (IV) infusion on Day 1 of each of the first four 21-day cycles during chemotherapy, followed by single agent administration until disease progression, unacceptable toxicity, discontinuation from study, or death. Cisplatin 75 mg/m² IV on Day 1 of each of the first four 21-day cycles OR carboplatin (area under the curve [AUC]=5 mg/mL/min, per Calvert formula) IV on Day 1 of each of the first four 21-day cycles; etoposide 100 mg/m² on Days 1-3 of each of the first four 21-day cycles. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pancytopenia | Blood and lymphatic system disorders | NCI CTCAE 3.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | NCI CTCAE 3.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Genentech, Inc. | 800-821-8590 |
| ID | Term |
|---|---|
| D055752 | Small Cell Lung Carcinoma |
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
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| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Chemotherapy | Drug | Chemotherapy = cisplatin (or carboplatin) + etoposide. Cisplatin 75 mg/m² IV on Day 1 of each of the first four 21-day cycles OR carboplatin (area under the curve [AUC]=5 mg/mL/min, per Calvert formula) IV on Day 1 of each of the first four 21-day cycles; etoposide 100 mg/m² on Days 1-3 of each of the first four 21-day cycles. |
|
| Placebo | Drug | Placebo 15 mg/kg by intravenous (IV) infusion on Day 1 of each of the first four 21-day cycles during chemotherapy, followed by single agent administration until disease progression, unacceptable toxicity, discontinuation from study, or death. |
|
Objective response was defined as a complete or partial response (per RECIST) determined by two investigator assessments conducted at least 4 weeks apart.
Complete Response (CR), Partial Response (PR), Incomplete Response (IR), Stable Disease (SD) (per RECIST):
Target Lesions Non-Target Lesions New Lesions Overall Response CR CR No CR CR IR/SD No PR PR Non-PD No PR
| Randomization until progression or lost to follow-up (up to 2 years) |
| Number of Participants With an Objective Response | Objective response was defined as a complete or partial response (per RECIST) determined by two investigator assessments conducted at least 4 weeks apart. Complete Response (CR), Partial Response (PR), Incomplete Response (IR), Stable Disease (SD) (per RECIST): Target Lesions Non-Target Lesions New Lesions Overall Response CR CR No CR CR IR/SD No PR PR Non-PD No PR | Randomization until progression or lost to follow-up (up to 2 years) |
| Duration of Objective Response | Duration of response was defined as time from the first response date to disease progression or on-study death (i.e., death occurring any time from randomization to 30 days after the final treatment with bevacizumab/placebo). Objective response was defined as a complete or partial response (per RECIST) determined by two investigator assessments conducted at least 4 weeks apart. | Randomization until progression or lost to follow-up (up to 2 years) |
| BG001 | Bevacizumab+Chemotherapy | Chemotherapy = cisplatin (or carboplatin) + etoposide. Bevacizumab 15 mg/kg by intravenous (IV) infusion on Day 1 of each of the first four 21-day cycles during chemotherapy, followed by single agent administration until disease progression, unacceptable toxicity, discontinuation from study, or death. Cisplatin 75 mg/m² IV on Day 1 of each of the first four 21-day cycles OR carboplatin (area under the curve [AUC]=5 mg/mL/min, per Calvert formula) IV on Day 1 of each of the first four 21-day cycles; etoposide 100 mg/m² on Days 1-3 of each of the first four 21-day cycles. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Bevacizumab+Chemotherapy | Chemotherapy = cisplatin (or carboplatin) + etoposide. Bevacizumab 15 mg/kg by intravenous (IV) infusion on Day 1 of each of the first four 21-day cycles during chemotherapy, followed by single agent administration until disease progression, unacceptable toxicity, discontinuation from study, or death. Cisplatin 75 mg/m² IV on Day 1 of each of the first four 21-day cycles OR carboplatin (area under the curve [AUC]=5 mg/mL/min, per Calvert formula) IV on Day 1 of each of the first four 21-day cycles; etoposide 100 mg/m² on Days 1-3 of each of the first four 21-day cycles. |
|
|
|
| Secondary | Overall Survival | Duration of overall survival from randomization until death or loss to follow-up | Intent-to-treat population | Posted | Median | 95% Confidence Interval | Months | Randomization until death or lost of follow-up (up to 27 months) |
|
|
|
|
| Secondary | Percentage of Participants With an Objective Response | Objective response was defined as a complete or partial response (per RECIST) determined by two investigator assessments conducted at least 4 weeks apart. Complete Response (CR), Partial Response (PR), Incomplete Response (IR), Stable Disease (SD) (per RECIST): Target Lesions Non-Target Lesions New Lesions Overall Response CR CR No CR CR IR/SD No PR PR Non-PD No PR | Intent-to-treat population | Posted | Number | Percentage of participants | Randomization until progression or lost to follow-up (up to 2 years) |
|
|
|
|
| Secondary | Number of Participants With an Objective Response | Objective response was defined as a complete or partial response (per RECIST) determined by two investigator assessments conducted at least 4 weeks apart. Complete Response (CR), Partial Response (PR), Incomplete Response (IR), Stable Disease (SD) (per RECIST): Target Lesions Non-Target Lesions New Lesions Overall Response CR CR No CR CR IR/SD No PR PR Non-PD No PR | Posted | Number | number of participants | Randomization until progression or lost to follow-up (up to 2 years) |
|
|
|
| Secondary | Duration of Objective Response | Duration of response was defined as time from the first response date to disease progression or on-study death (i.e., death occurring any time from randomization to 30 days after the final treatment with bevacizumab/placebo). Objective response was defined as a complete or partial response (per RECIST) determined by two investigator assessments conducted at least 4 weeks apart. | Randomized patients with measurable disease at baseline. | Posted | Median | 95% Confidence Interval | Months | Randomization until progression or lost to follow-up (up to 2 years) |
|
|
|
|
| 11 |
| 47 |
| 31 |
| 47 |
| EG001 | Bevacizumab+Chemotherapy | Chemotherapy = cisplatin (or carboplatin) + etoposide. Bevacizumab 15 mg/kg by intravenous (IV) infusion on Day 1 of each of the first four 21-day cycles during chemotherapy, followed by single agent administration until disease progression, unacceptable toxicity, discontinuation from study, or death. Cisplatin 75 mg/m² IV on Day 1 of each of the first four 21-day cycles OR carboplatin (area under the curve [AUC]=5 mg/mL/min, per Calvert formula) IV on Day 1 of each of the first four 21-day cycles; etoposide 100 mg/m² on Days 1-3 of each of the first four 21-day cycles. | 20 | 51 | 35 | 51 |
| Febrile Neutropenia | Blood and lymphatic system disorders | NCI CTCAE 3.0 | Non-systematic Assessment |
|
| Cardiac Failure Congestive | Cardiac disorders | NCI CTCAE 3.0 | Non-systematic Assessment |
|
| Myocardial Infarction | Cardiac disorders | NCI CTCAE 3.0 | Non-systematic Assessment |
|
| Pericardial Effusion | Cardiac disorders | NCI CTCAE 3.0 | Non-systematic Assessment |
|
| Tachycardia | Cardiac disorders | NCI CTCAE 3.0 | Non-systematic Assessment |
|
| Atrial Fibrillation | Cardiac disorders | NCI CTCAE 3.0 | Non-systematic Assessment |
|
| Cardiac Arrest | Cardiac disorders | NCI CTCAE 3.0 | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | NCI CTCAE 3.0 | Non-systematic Assessment |
|
| Gastrointestinal Perforation | Gastrointestinal disorders | NCI CTCAE 3.0 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | NCI CTCAE 3.0 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | NCI CTCAE 3.0 | Non-systematic Assessment |
|
| Gastrointestinal Hemorrhage | Gastrointestinal disorders | NCI CTCAE 3.0 | Non-systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | NCI CTCAE 3.0 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | NCI CTCAE 3.0 | Non-systematic Assessment |
|
| Ileus | Gastrointestinal disorders | NCI CTCAE 3.0 | Non-systematic Assessment |
|
| Death | General disorders | NCI CTCAE 3.0 | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | NCI CTCAE 3.0 | Non-systematic Assessment |
|
| Lobar Pneumonia | Infections and infestations | NCI CTCAE 3.0 | Non-systematic Assessment |
|
| Road Traffic Accident | Injury, poisoning and procedural complications | NCI CTCAE 3.0 | Non-systematic Assessment |
|
| Hemoglobin Decreased | Investigations | NCI CTCAE 3.0 | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | NCI CTCAE 3.0 | Non-systematic Assessment |
|
| Electrolyte Imbalance | Metabolism and nutrition disorders | NCI CTCAE 3.0 | Non-systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | NCI CTCAE 3.0 | Non-systematic Assessment |
|
| Depressed Level of Consciousness | Nervous system disorders | NCI CTCAE 3.0 | Non-systematic Assessment |
|
| Reversible Posterior Leukoencephalopathy Syndrome | Nervous system disorders | NCI CTCAE 3.0 | Non-systematic Assessment |
|
| Mental Status Changes | Psychiatric disorders | NCI CTCAE 3.0 | Non-systematic Assessment |
|
| Renal Failure | Renal and urinary disorders | NCI CTCAE 3.0 | Non-systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | NCI CTCAE 3.0 | Non-systematic Assessment |
|
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | NCI CTCAE 3.0 | Non-systematic Assessment |
|
| Chronic Obstructive Pulmonary Disease | Respiratory, thoracic and mediastinal disorders | NCI CTCAE 3.0 | Non-systematic Assessment |
|
| Hemoptysis | Respiratory, thoracic and mediastinal disorders | NCI CTCAE 3.0 | Non-systematic Assessment |
|
| Stridor | Respiratory, thoracic and mediastinal disorders | NCI CTCAE 3.0 | Non-systematic Assessment |
|
| Hydropneumothorax | Respiratory, thoracic and mediastinal disorders | NCI CTCAE 3.0 | Non-systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | NCI CTCAE 3.0 | Non-systematic Assessment |
|
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | NCI CTCAE 3.0 | Non-systematic Assessment |
|
| Deep Vein Thrombosis | Vascular disorders | NCI CTCAE 3.0 | Non-systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | NCI CTCAE 3.0 | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | NCI CTCAE 3.0 | Non-systematic Assessment |
|
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.
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D013812 | Therapeutics |