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| Name | Class |
|---|---|
| Bristol-Myers Squibb | INDUSTRY |
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This clinical trial involves the administration of the chemotherapeutic medication vinflunine. Vinflunine is not approved by the FDA and is experimental in the treatment of extensive small cell lung cancer. The purpose of this research trial is to study the effectiveness of vinflunine in patients with relapsed extensive small cell lung cancer, evaluate the toxicity, and evaluate how long the response to this drug lasts.
Eligible patients will receive vinflunine as a 15-20 minute intravenous (IV)infusion once every three weeks (21 days). This three week treatment period is called a cycle. Patients whose cancer has not grown or if it has decreased in size may receive up to 6 cycles of vinflunine. Evaluation will be conducted every other cycle.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Patients received vinflunine 320 mg/m2 every 21 days as a 15- to 20-minute infusion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vinflunine | Drug | 320mg/m2 every 21 days as a 15-20 minute infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment | Overall response rate is the percentage of patients with complete response or partial response per RECIST v.1 Criteria. Complete response (CR) = Disappearance of all target lesions, disappearance of all nontarget lesions for at least 4 weeks. Partial Response (PR) = At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameters. The final response criteria assigned represented the best response obtained during treatment. | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Response, the Length of Time, in Months, That Protocol Treatment Produced an Objective Improvement in Patients' Disease | The Response Duration was calculated from time of initial measured response to date of first observation of progressive disease. | 18 months |
| Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David R. Spigel, MD | SCRI Development Innovations, LLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Florida Cancer Specialists | Fort Myers | Florida | 33901 | United States | ||
| Oncology Hematology Care |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20521355 | Result | Spigel DR, Hainsworth JD, Lane CM, Clark B, Burris HA, Greco FA. Phase II trial of vinflunine in relapsed small cell lung cancer. J Thorac Oncol. 2010 Jun;5(6):874-8. doi: 10.1097/jto.0b013e3181d86b76. |
| Label | URL |
|---|---|
| Published article in the Journal of Thoracic Oncology | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Vinflunine | Patients received vinflunine 320 mg/m2 every 21 days as a 15- to 20-minute infusion. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Vinflunine | Patients received vinflunine 320 mg/m2 every 21 days as a 15- to 20-minute infusion. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of 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 | Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment | Overall response rate is the percentage of patients with complete response or partial response per RECIST v.1 Criteria. Complete response (CR) = Disappearance of all target lesions, disappearance of all nontarget lesions for at least 4 weeks. Partial Response (PR) = At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameters. The final response criteria assigned represented the best response obtained during treatment. | All patients were assessed for response. | Posted | Number | 95% Confidence Interval | percentage of participants | 18 months |
|
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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 | Vinflunine | Patients received vinflunine 320 mg/m2 every 21 days as a 15- to 20-minute infusion. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John Hainsworth, MD | Sarah Cannon Research Institute | 1-877-691-7274 | asksarah@scresearch.net |
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| ID | Term |
|---|---|
| D018288 | Carcinoma, Small Cell |
| D008175 | Lung Neoplasms |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C111217 | vinflunine |
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Overall survival was measured from the date of study entry until the date of death. |
| 18 months |
| Progression Free Survival (PFS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease | Progression free survival was defined as the interval between the start date of treatment and the date of occurrence of progressive disease or death. | 18 months |
| Cincinnati |
| Ohio |
| 45242 |
| United States |
| Tennessee Oncology, PLLC | Nashville | Tennessee | 37023 | United States |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Duration of Response, the Length of Time, in Months, That Protocol Treatment Produced an Objective Improvement in Patients' Disease | The Response Duration was calculated from time of initial measured response to date of first observation of progressive disease. | All patients were assessed for response. Only patients with objective response were analyzed for response duration. | Posted | Median | 95% Confidence Interval | Months | 18 months |
|
|
|
| Secondary | Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death | Overall survival was measured from the date of study entry until the date of death. | All patients were assessed for overall survival. | Posted | Median | 95% Confidence Interval | Months | 18 months |
|
|
|
| Secondary | Progression Free Survival (PFS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease | Progression free survival was defined as the interval between the start date of treatment and the date of occurrence of progressive disease or death. | All patients were assessed for progression free survival. | Posted | Median | 95% Confidence Interval | Months | 18 months |
|
|
|
| 31 |
| 51 |
| 30 |
| 51 |
| Death not associated with CTCAE term - Disease Progression NOS | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Failure to thrive | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Fatigue | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Febrile Neutropenia | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Hemoglobin | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Infection - Other (Pneumonia) | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Altered Mental Status | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Neuropathy | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Neutrophils | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Obstruction, GI - Small Bowel NOS | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pain - abdomen | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pain - joint | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pain - Other (Pain Syndrome) | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pancreatic endocrine: glucose intolerance | Endocrine disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Supraventricular and nodal arrhythmia - Atrial Fibrillation | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
|
| Systemic lupus erythematosus | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Leukocytes | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Platelets | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hemoglobin | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Anorexia | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| AST | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Dehydration | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Edema | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Fatigue | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Fever | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hypertension | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Insomnia | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Mucositis | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Nausea (intermittent) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Neuropathy (sensory) | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pain | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pain (abdominal) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pain (bone) | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pain (chest) | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pain (headache) | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pain (jaw) | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Sore throat | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Vomiting (intermittent) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Weakness | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Weight Loss | General disorders | CTCAE (3.0) | Systematic Assessment |
|
The sponsor can review/embargo results communications prior to public release for a period that is >60 days but ≤180 days from date submitted to sponsor, who may require changes to the communication in order to remove specifically identified confidential information (other than study data) and/or delay the proposed publication to enable the sponsor to seek patent protection for inventions. The PI may not publish its results until 18 mos. after the trial has been completed at all sites.
| D012142 |
| Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |