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| Name | Class |
|---|---|
| Genentech, Inc. | INDUSTRY |
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The purpose of this study is to see if higher dose of bevacizumab can be taken safely by some patients and if changes in the dose of bevacizumab have any effect on blood pressure.
Carboplatin and pemetrexed are FDA approved chemotherapy agents for patients with advanced non squamous non small cell lung cancer. Bevacizumab is also FDA approved in lung cancer , and the combination of all three drugs is promising. The doctors directing this research want to learn how to better personalize drug dosing of bevacizumab by identifying people who could safely take a higher dose of the drug.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Active Comparator | Carboplatin and Pemetrexed with Bevacizumab 7.5 mg/kg once, followed three weeks later by Carboplatin and Pemetrexed with Bevacizumab 7.5 mg/kg and bevacizumab every 3 weeks for two doses |
|
| Group B | Active Comparator | Carboplatin and Pemetrexed with Bevacizumab 7.5 mg/kg once, followed three weeks later by Carboplatin+Pemetrexed+Bevacizumab 15 mg/kg and bevacizumab every 3 weeks for two doses |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pemetrexed | Drug | Pemetrexed 500 mg/m^2 intravenously over 10 minutes |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in 24 Hour Diastolic Blood Pressure (DBP) | The change for each patient was calculated as mean 24 hour DBP during cycle 2 - mean 24 hour DBP during cycle 1 | 2 cycles |
| Measure | Description | Time Frame |
|---|---|---|
| Response Rate | Percentage of patients with a complete or partial response. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
Disease-Specific
Patients who have had received prior chemotherapy (in the setting of recurrent disease, other than their original adjuvant therapy)
Patients may not be receiving any other investigational agents.
Patients with histologic evidence of predominantly squamous lung cell cancer
Inability to comply with study and/or follow-up procedures
Malignancy other than superficial basal cell and superficial squamous of the skin or carcinoma in situ of the cervix within last five years
Bevacizumab-Specific Exclusions
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| Name | Affiliation | Role |
|---|---|---|
| Michael Maitland, MD., Ph.d | The University of Chicago Medical Center | Principal Investigator |
| Michael Maitland, MD., PhD | The University of Chicago Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Chicago Medical Center | Chicago | Illinois | 60637 | United States | ||
| North Shore University Health System |
All enrolled patients received one cycle and those who tolerated it and had no evidence of risk for dose escalation were randomized to receive one of two treatment regimens.
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| ID | Title | Description |
|---|---|---|
| FG000 | All Participants | All participants enrolled received Carboplatin and Pemetrexed with Bevacizumab 7.5 mg/kg once during the first cycle. |
| FG001 | Group A | Carboplatin and Pemetrexed with Bevacizumab 7.5 mg/kg once during first cycle, followed three weeks later by Carboplatin and Pemetrexed with Bevacizumab 7.5 mg/kg and bevacizumab every 3 weeks for two doses |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Cycle 1 |
|
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| Carboplatin |
| Drug |
Carboplatin at a dose calculated to produce an area under the concentration-time curve of 6 mg/ml•min intravenously over 30 minutes |
|
| Bevacizumab 7.5 mg/kg | Drug | Bevacizumab at 7.5 mg/kg intravenously over 90 minutes |
|
| Bevacizumab 15 mg/kg | Drug | Bevacizumab at 15 mg/kg intravenously over 90 minutes |
|
| Change in Tumor Size From Baseline | 2 years |
| Progression Free Survival | Time to progression or death from any cause, whichever comes first | 2 years |
| Evanston |
| Illinois |
| 60201 |
| United States |
| Ingalls Memorial Hospital | Harvey | Illinois | 60426 | United States |
| FG002 | Group B | Carboplatin and Pemetrexed with Bevacizumab 7.5 mg/kg once during first cycle, followed three weeks later by Carboplatin+Pemetrexed+Bevacizumab 15 mg/kg and bevacizumab every 3 weeks for two doses |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Randomized Phase (Cycle 2 and Beyond) |
|
All patients enrolled and evaluable during the randomization phase.
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| ID | Title | Description |
|---|---|---|
| BG000 | Group A | Carboplatin and Pemetrexed with Bevacizumab 7.5 mg/kg once, followed three weeks later by Carboplatin and Pemetrexed with Bevacizumab 7.5 mg/kg and bevacizumab every 3 weeks for two doses |
| BG001 | Group B | Carboplatin and Pemetrexed with Bevacizumab 7.5 mg/kg once, followed three weeks later by Carboplatin+Pemetrexed+Bevacizumab 15 mg/kg and bevacizumab every 3 weeks for two doses |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | 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 | Change in 24 Hour Diastolic Blood Pressure (DBP) | The change for each patient was calculated as mean 24 hour DBP during cycle 2 - mean 24 hour DBP during cycle 1 | Posted | Mean | Standard Deviation | mmHg | 2 cycles |
|
|
| |||||||||||||||||||||||||||||
| Secondary | Response Rate | Percentage of patients with a complete or partial response. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. | Posted | Count of Participants | Participants | 2 years |
|
| |||||||||||||||||||||||||||||||
| Secondary | Change in Tumor Size From Baseline | Because the study did not meet its accrual goals, the study team did not proceed to collect this secondary outcome measure. The data were not collected and therefore are not available to report. | Posted | 2 years |
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| |||||||||||||||||||||||||||||||||
| Secondary | Progression Free Survival | Time to progression or death from any cause, whichever comes first | Because the study did not meet its accrual goals, the study team did not proceed to collect this secondary outcome measure. The data were not collected and therefore are not available to report. | Posted | 2 years |
|
|
6 months
Other adverse events grade 2 or higher are reported.
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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 | Group A | Carboplatin and Pemetrexed with Bevacizumab 7.5 mg/kg once, followed three weeks later by Carboplatin and Pemetrexed with Bevacizumab 7.5 mg/kg and bevacizumab every 3 weeks for two doses | 0 | 6 | 6 | 6 | ||
| EG001 | Group B | Carboplatin and Pemetrexed with Bevacizumab 7.5 mg/kg once, followed three weeks later by Carboplatin+Pemetrexed+Bevacizumab 15 mg/kg and bevacizumab every 3 weeks for two doses | 1 | 11 | 11 | 11 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dehydration | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Hypotension | Vascular disorders | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Alopecia | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Chest pain | General disorders | Non-systematic Assessment |
| ||
| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Dehydration | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Diaphoresis | General disorders | Non-systematic Assessment |
| ||
| Dysgeusia | Nervous system disorders | Non-systematic Assessment |
| ||
| Hypertension | Vascular disorders | Non-systematic Assessment |
| ||
| Alanine aminotransferase increased | Investigations | Non-systematic Assessment |
| ||
| Aspartate aminotransferase increased | Investigations | Non-systematic Assessment |
| ||
| Retinal tear | Eye disorders | Non-systematic Assessment |
| ||
| Dyspepsia | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| pain | General disorders | Non-systematic Assessment |
| ||
| Oral pain | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Proteinuria | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Swollen feet | General disorders | Non-systematic Assessment |
| ||
| Platelet count decreased | Investigations | Non-systematic Assessment |
| ||
| Upper respiratory symptoms | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Neutrophil count decreased | Investigations | Non-systematic Assessment |
| ||
| Mucositis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| white blood cell decreased | Investigations | Non-systematic Assessment |
| ||
| Fatigue | General disorders | Non-systematic Assessment |
| ||
| Anorexia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Anxiety | Psychiatric disorders | Non-systematic Assessment |
| ||
| Depression | Psychiatric disorders | Non-systematic Assessment |
| ||
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Vertigo | Ear and labyrinth disorders | Non-systematic Assessment |
| ||
| urinary tract infection | Infections and infestations | Non-systematic Assessment |
| ||
| Cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Headache | Nervous system disorders | Non-systematic Assessment |
| ||
| Insomnia | Psychiatric disorders | Non-systematic Assessment |
| ||
| Epistaxis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Hyperglycemia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Stroke | Nervous system disorders | Non-systematic Assessment |
| ||
| Thromboembolic event | Vascular disorders | Non-systematic Assessment |
| ||
| Abdominal pain | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Hypoalbuminemia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Creatinine increased | Investigations | Non-systematic Assessment |
| ||
| GERD | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Intermittent periorbital edema | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Sinus infection | Infections and infestations | Non-systematic Assessment |
| ||
| Thrush | Infections and infestations | Non-systematic Assessment |
| ||
| otitis externa | Infections and infestations | Non-systematic Assessment |
| ||
| heart murmur | Cardiac disorders | Non-systematic Assessment |
| ||
| Hepatitis | Infections and infestations | Non-systematic Assessment |
|
Recruitment was slow and the study did not meet its accrual goals.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Maitland, MD, PhD | Inova | 571-472-4724 | Michael.Maitland@inova.org |
| ID | Term |
|---|---|
| D000068437 | Pemetrexed |
| D016190 | Carboplatin |
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D005971 | Glutamates |
| D024342 | Amino Acids, Acidic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000600 | Amino Acids, Dicarboxylic |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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| Male |
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| Black non-Hispanic |
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| Asian |
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