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| ID | Type | Description | Link |
|---|---|---|---|
| H-2008-0229 | Other Identifier | Institutional Review Board | |
| A534260 | Other Identifier | UW Madison | |
| SMPH\MEDICINE\HEM-ONC | Other Identifier | UW Madison | |
| NCI-2011-00811 | Registry Identifier | NCI Trial ID |
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| Name | Class |
|---|---|
| Millennium Pharmaceuticals, Inc. | INDUSTRY |
| Merck Sharp & Dohme LLC | INDUSTRY |
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The purpose of this study is to evaluate the efficacy of vorinostat and bortezomib in the third line treatment of advanced NSCLC, as well as to assess toxicity (including neuropathy) and tolerability of this regimen.
Current treatment for non-small cell lung cancer (NSCLC) remains inadequate. Vorinostat is a novel agent that inhibits the enzymatic activity of histone deacetylases (HDACs). Bortezomib is a small molecule proteasome inhibitor. Preclinical and clinical studies have shown the advantages of combining these two agents in the treatment of NSCLC
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vorinostat + Bortezomib | Experimental | Vorinostat 400 mg + Bortezomib 1.3 mg/m2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| vorinostat | Drug | 400 mg by mouth once daily for days 1-14 of each 21 day cycle |
|
| Measure | Description | Time Frame |
|---|---|---|
| Three-month Progression-free Survival | Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST), as a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since the treatment started or the appearance of one or more new lesions." | Three-months post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Response Rate | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) for target lesions and assessed by MRI, CT, or chest x-ray: 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. | Until disease progression, up to 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tien Hoang, M.D. | University of Wisconsin, Madison | Principal Investigator |
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Recruitment occurred during 2/16/2008 and 03/09/2010.
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| ID | Title | Description |
|---|---|---|
| FG000 | Vorinostat + Bortezomib | Vorinostat 400 mg + Bortezomib 1.3 mg/m2 vorinostat: 400 mg by mouth once daily for days 1-14 of each 21 day cycle bortezomib: 1.3 mg/m2 IV on days 1, 4, 8, 11 of each 21 day cycle |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Vorinostat + Bortezomib | Vorinostat 400 mg + Bortezomib 1.3 mg/m2 vorinostat: 400 mg by mouth once daily for days 1-14 of each 21 day cycle bortezomib: 1.3 mg/m2 IV on days 1, 4, 8, 11 of each 21 day cycle |
| 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 | Three-month Progression-free Survival | Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST), as a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since the treatment started or the appearance of one or more new lesions." | Posted | Number | 95% Confidence Interval | percentage of participants | Three-months post-treatment |
|
|
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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 | Vorinostat + Bortezomib | Vorinostat 400 mg + Bortezomib 1.3 mg/m2 vorinostat: 400 mg by mouth once daily for days 1-14 of each 21 day cycle bortezomib: 1.3 mg/m2 IV on days 1, 4, 8, 11 of each 21 day cycle |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphopenia | Blood and lymphatic system disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Abigail Mapes, Thoracic Oncology Research Program Manager | University of Wisconsin | (608) 262-8158 | acmapes@medicine.wisc.edu |
| 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 |
|---|---|
| D000077337 | Vorinostat |
| D000069286 | Bortezomib |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| bortezomib | Drug | 1.3 mg/m2 IV on days 1, 4, 8, 11 of each 21 day cycle |
|
|
| Median Overall Survival | 5 years |
| Toxicity | Graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 | 30 days post-treatment |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Histology | Number | participants |
|
| Performance Status | Assigned following the Eastern Cooperative Oncology Group (ECOG) scale. Scores range from 0 (fully active) to 5 (dead). | Number | participants |
|
| Disease Stage | Disease stage per American Joint Committee on Cancer (AJCC) Lung Cancer Staging | Number | participants |
|
| Prior first-line systemic therapy | Number | participants |
|
| Response to first-line therapy | Number | participants |
|
| Prior second-line systemic therapy | Number | participants |
|
| Response to second-line therapy | Number | participants |
|
| Prior thoracic radiation therapy | Number | participants |
|
| Participants |
|
|
| Secondary | Response Rate | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) for target lesions and assessed by MRI, CT, or chest x-ray: 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 | Number | participants | Until disease progression, up to 2 years |
|
|
|
| Secondary | Median Overall Survival | Posted | Median | 95% Confidence Interval | months | 5 years |
|
|
|
| Secondary | Toxicity | Graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 | Posted | Number | participants | 30 days post-treatment |
|
|
|
| 8 |
| 18 |
| 0 |
| 18 |
| Platelets | Blood and lymphatic system disorders |
|
| Pericardial effusion (non-malignant) | Cardiac disorders |
|
| Pericarditis | Cardiac disorders |
|
| Failure to thrive | General disorders |
|
| Fatigue | General disorders |
|
| Fistula, esophagus | Gastrointestinal disorders |
|
| Hypoalbuminemia | Metabolism and nutrition disorders |
|
| Hyponatremia | Metabolism and nutrition disorders |
|
| Confusion | Nervous system disorders |
|
| Dizziness | Nervous system disorders |
|
| Neuropathy, motor | Nervous system disorders |
|
| Psychosis | Nervous system disorders |
|
| Syncope | Nervous system disorders |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders |
|
| Pleural effusion (non-malignant) | Respiratory, thoracic and mediastinal disorders |
|
| Systemic inflammatory response syndrome | General disorders |
|
| Thrombosis/Thrombus/Embolism | Vascular disorders |
|
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| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000588 |
| Amines |
| D006877 | Hydroxamic Acids |
| D006898 | Hydroxylamines |
| D006880 | Hydroxy Acids |
| D002264 | Carboxylic Acids |
| D001897 | Boronic Acids |
| D000148 | Acids, Noncarboxylic |
| D000143 | Acids |
| D007287 | Inorganic Chemicals |
| D001896 | Boron Compounds |
| D011719 | Pyrazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| Title | Measurements |
|---|---|
|
|
| Fatigue Grade 3 |
|
| Fatigue Grade 4 |
|
| Vomiting Grade 3 |
|
| Dizziness Grade 3 |
|
| Syncope Grade 3 |
|
| Neuropathy Grade 3 |
|
| Hyponatremia Grade 3 |
|