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| Name | Class |
|---|---|
| Ligand Pharmaceuticals | INDUSTRY |
| Genentech, Inc. | INDUSTRY |
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The purpose of this study is to learn about the effects of two new anticancer drugs, erlotinib (Tarceva) and bexarotene (Targretin), when treating patients with advanced lung cancer.
Erlotinib is approved by the Food and Drug Administration (FDA) for the treatment of non-small-cell lung cancer (NSCLC). Bexarotene is approved by the FDA for the treatment of cutaneous T-cell lymphoma. This combination of drugs is experimental.
This is a single institution open label phase II trial. Consecutive, eligible patients presenting with the diagnosis of advanced NSCLC are to be enrolled in this study. All eligible patients will receive continuous daily oral erlotinib 150 mg (Tarceva™) with daily bexarotene oral capsules 400 mg/m2 (Targretin®). The two agents will be taken at the same time. We anticipate the maximum accrual of 40 patients to this trial.
Patients will be evaluated by history, physical examination, and laboratory assessment every 4 weeks. Radiographic disease assessments by chest radiograph will be obtained every 4 weeks and computer tomography every 8 weeks or longer if clinically indicated. Whole body PET scan will be obtained at 10 days and 8 weeks. All radiographic studies will be sent to Medical Metrix Solutions (MMS) for an independent radiographic review of tumor response.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | All eligible patients will receive continuous daily oral erlotinib 150mg with daily bexarotene oral capsules 400mg. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| erlotinib and bexarotene | Drug | Daily Erlotinib 150mg and daily bexarotene oral capsules 400mg. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Radiographic Response Rates | 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 | Through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation of Early PET Responses With Objective Radiographic Responses. | PET response is assessed based on the guidelines of the European Organization for Research and Treatment of Cancer (EORTC) PET Study Group (Eur J Cancer 1999; 35(13):1773-82). PET response refers to the presence and measurement of the most current PET scan imaging when compared to baseline imaging. The amount of reduction in the disease from baseline to current imaging determines the extent to which the cancer has responded to treatment. Radiographic response is 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Konstantin H Dragnev, MD | Norris Cotton Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Norris Cotton Cancer Center | Lebanon | New Hampshire | 03756 | United States | ||
| Mount Sinai School of Medicine |
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| ID | Title | Description |
|---|---|---|
| FG000 | Single Arm Erlotinib + Bexarotene | All eligible patients will receive continuous daily oral erlotinib 150mg with daily bexarotene oral capsules 400mg. erlotinib and bexarotene: Daily Erlotinib 150mg and daily bexarotene oral capsules 400mg. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Single Arm Erlotinib + Bexarotene | All eligible patients will receive continuous daily oral erlotinib 150mg with daily bexarotene oral capsules 400mg. erlotinib and bexarotene: Daily Erlotinib 150mg and daily bexarotene oral capsules 400mg. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Radiographic Response Rates | 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 | Through study completion, an average of 1 year |
|
|
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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 | Single Arm Erlotinib + Bexarotene | All eligible patients will receive continuous daily oral erlotinib 150mg with daily bexarotene oral capsules 400mg. erlotinib and bexarotene: Daily Erlotinib 150mg and daily bexarotene oral capsules 400mg. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hallucinations | Psychiatric disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Konstantin Dragnev, MD | Dartmouth-Hitchcock Medical Center | 603-650-6344 | Konstantin.H.Dragnev@Hitchcock.org |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D002277 | Carcinoma |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| D000069347 | Erlotinib Hydrochloride |
| D000077610 | Bexarotene |
| ID | Term |
|---|---|
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Through study completion, an average of 1 year |
| Progression-free Survival and Overall Survival | Through study completion, an average of 1 year |
| Evaluation of EGFR Mutations in Tumor Biopsies and Correlation of EGFR Mutations With Objective Radiographic Responses. | Through study completion, an average of 1 year |
| New York |
| New York |
| 10029 |
| United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Disease Stage IV | The clinical stage of disease for participants will be Stage IV (Stage 4) disease. Staging is based on different characteristics of the cancer diagnosis that determine how advanced the cancer is. | Count of Participants | Participants |
|
| Histopathology | Includes multiple histopathology types (adenocarcinoma and brochioloalveolar type). | Number | participants |
|
| Prior anti-EGFR therapy | Count of Participants | Participants |
|
| Number of prior chemotherapies | Median | Full Range | chemotherapies |
|
| Smoking status | Count of Participants | Participants |
|
| Counts |
|---|
| Participants |
|
|
| Secondary | Correlation of Early PET Responses With Objective Radiographic Responses. | PET response is assessed based on the guidelines of the European Organization for Research and Treatment of Cancer (EORTC) PET Study Group (Eur J Cancer 1999; 35(13):1773-82). PET response refers to the presence and measurement of the most current PET scan imaging when compared to baseline imaging. The amount of reduction in the disease from baseline to current imaging determines the extent to which the cancer has responded to treatment. Radiographic response is 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 | Number of participants analyzed is reported per achieved disease response noted in individual rows. | Posted | Count of Participants | Participants | Through study completion, an average of 1 year |
|
|
|
| Secondary | Progression-free Survival and Overall Survival | Posted | Median | Full Range | Weeks | Through study completion, an average of 1 year |
|
|
|
| Secondary | Evaluation of EGFR Mutations in Tumor Biopsies and Correlation of EGFR Mutations With Objective Radiographic Responses. | Three patients had biopsies evaluated for EGFR mutations. | Posted | Count of Participants | Participants | Through study completion, an average of 1 year |
|
|
|
| 4 |
| 42 |
| 30 |
| 42 |
| 14 |
| 42 |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Chest pain | Cardiac disorders | Non-systematic Assessment |
|
| Pericardial effusion | Cardiac disorders | Non-systematic Assessment |
|
| Hemoptysis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Anxiety Disorder | Psychiatric disorders | Non-systematic Assessment |
|
| Post-obstructive Pneumonia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Bacterial pneumonia | Infections and infestations | Non-systematic Assessment |
|
| Mental status changes | Psychiatric disorders | Non-systematic Assessment |
|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Pulmonary Hemorrhage | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | Non-systematic Assessment |
|
| Declining respiratory status | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Acute renal failure | Renal and urinary disorders | Non-systematic Assessment |
|
| Fatigue | General disorders | Non-systematic Assessment |
|
| INR increased | Investigations | Non-systematic Assessment |
|
| Hypertriglyceridemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Activated partial thromboplastin time prolonged | Investigations | Non-systematic Assessment |
|
| Increased white blood cell count | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Investigations - Other, elevated granulocytes | Investigations | Non-systematic Assessment |
|
| Hypernatremia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Proximal muscle weakness | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Neutrophil count decreased | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Cholesterol high | Investigations | Non-systematic Assessment |
|
| Mouth sores | Gastrointestinal disorders | Non-systematic Assessment |
|
| Arm pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
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| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| Early PET stable disease |
|
| Early PET progression |
|
| Computed tomography partial response |
|
|
| Computed tomography stable disease |
|
|
| Computed tomography disease progression |
|
|
| PR in Activating EGFR mutation at exon 21 |
|