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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2009-01584 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| P30CA036727 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This phase II trial studies the side effects and how well vinorelbine tartrate and paclitaxel works in treating older patients with non-small cell lung cancer that has spread to other placed in the body. Drugs used in chemotherapy, such as vinorelbine tartrate and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving combination chemotherapy may kill more tumor cells.
PRIMARY OBJECTIVES: I. To assess the safety and efficacy of a combination of vinorelbine and paclitaxel administered weekly to elderly patients with advanced non-small cell lung cancer. II. To assess the response rate of a combination of vinorelbine and paclitaxel administered weekly to elderly patients with advanced non-small cell lung cancer. III. To assess the quality of life of elderly patients with advanced non-small cell lung cancer during administration of weekly paclitaxel and vinorelbine. OUTLINE: Patients receive vinorelbine tartrate intravenously (IV) over 6-10 minutes and paclitaxel IV over 1 hour once weekly for 6 weeks. Treatment repeats every 8 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 5 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (vinorelbine tartrate, paclitaxel) | Experimental | Patients receive vinorelbine tartrate IV over 6-10 minutes and paclitaxel IV over 1 hour once weekly for 6 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paclitaxel | Drug | Given IV |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival. | Time from first therapy until first documentation of clinical progression, relapse or death. Progression was defined as per RECIST v1.0 criteria as an at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions. The Kaplan-Meier method will be used to estimate time to event distributions. | Time from first therapy until first documentation of clinical progression, relapse or death assessed up to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of >Grade 3 Treatment-Emergent Non-hematological Adverse Events | Toxicity will be assessed at the 0.05 two-sided level of significance. The Common Terminology Criteria for Adverse Events Version 3.0 will be used to grade the severity of adverse events. | Up to week 17 |
| Response Rate Based on RECIST Criteria |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Apar K Ganti, MD | University of Nebraska | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHI Health Saint Francis | Grand Island | Nebraska | 68803 | United States | ||
| Great Plains Regional Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27491498 | Result | Huerter MM, Meza JL, Copur MS, Tolentino A, Marr AS, Ketcham M, DeSpiegelaere H, Kruse S, Kos ME, Swenson K, Radniecki SE, Kessinger A, Ganti AK. Weekly vinorelbine and paclitaxel in older patients with advanced non-small cell lung cancer: A phase II Fred and Pamela Buffet Cancer Center Clinical Trials Network study. J Geriatr Oncol. 2017 Jan;8(1):18-22. doi: 10.1016/j.jgo.2016.07.006. Epub 2016 Aug 1. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment | This is a non-randomized, single-arm, phase II study of vinorelbine and paclitaxel in older patients with advanced non-small cell lung cancer. Vinorelbine (22.5 mg/m2) and paclitaxel (40 mg/m2) were given weekly for six weeks followed by a two-week break. Each patient received a maximum of two cycles (12 doses) of chemotherapy. All patients received standard premedication for nausea and hypersensitivity prophylaxis per individual institutional guidelines. Quality of life (QoL) was assessed at baseline, week 9, and week 17 using the Functional Assessment of Cancer Therapy lung cancer subscale instrument (FACT-L). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Quality-of-Life Assessment | Other | Ancillary studies |
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| Questionnaire Administration | Other | Ancillary studies |
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| Vinorelbine Tartrate | Drug | Given IV |
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The measurement of effect will be based on the Response Evaluation Criteria In Solid Tumors criteria. Response rate is the sum of complete and partial responses. Complete Response is defined as the disappearance of all target lesions. Partial Response is defined as an at least 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter |
| Up to 5 years |
| North Platte |
| Nebraska |
| 69103 |
| United States |
| Veterans Administration Medical Center, Omaha | Omaha | Nebraska | 68105 | United States |
| University of Nebraska Medical Center | Omaha | Nebraska | 68198 | United States |
| Avera McKennan Hospital and University Health Center | Sioux Falls | South Dakota | 57105 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment (Vinorelbine Tartrate, Paclitaxel) | Patients receive vinorelbine tartrate IV over 6-10 minutes and paclitaxel IV over 1 hour once weekly for 6 weeks. Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies Vinorelbine Tartrate: Given IV |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Age in years. Patients >70 years were eligible | Mean | Standard Deviation | years |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
| |||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
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| 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. | Time from first therapy until first documentation of clinical progression, relapse or death. Progression was defined as per RECIST v1.0 criteria as an at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions. The Kaplan-Meier method will be used to estimate time to event distributions. | Posted | Median | 95% Confidence Interval | Months | Time from first therapy until first documentation of clinical progression, relapse or death assessed up to 5 years |
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| Secondary | Incidence of >Grade 3 Treatment-Emergent Non-hematological Adverse Events | Toxicity will be assessed at the 0.05 two-sided level of significance. The Common Terminology Criteria for Adverse Events Version 3.0 will be used to grade the severity of adverse events. | Posted | Count of Participants | Participants | Up to week 17 |
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| Secondary | Response Rate Based on RECIST Criteria | The measurement of effect will be based on the Response Evaluation Criteria In Solid Tumors criteria. Response rate is the sum of complete and partial responses. Complete Response is defined as the disappearance of all target lesions. Partial Response is defined as an at least 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter | Posted | Count of Participants | Participants | Up to 5 years |
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All cause mortality is reported for the 20 patients enrolled in the study. Adverse event and Serious adverse events reporting is out of the 19 patients that were treated on the study. One of the patients enrolled on this study deteriorated before treatment and was not treated on the study.
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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 | Treatment (Vinorelbine Tartrate, Paclitaxel) | Patients receive vinorelbine tartrate IV over 6-10 minutes and paclitaxel IV over 1 hour once weekly for 6 weeks. Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies Vinorelbine Tartrate: Given IV | 16 | 20 | 6 | 19 | 19 | 19 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Ischemic encephalopathy | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
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| Acute hypoxic respiratory failure | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
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| pulmonary infiltrates | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
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| Leukopenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
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| Lymphopenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
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| pulmonary infiltrates | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Febrile neutropenia | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| hypoxemia | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| back pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
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| Anorexia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
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| Hyperglycemia | Endocrine disorders | CTCAE (3.0) | Systematic Assessment |
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| Pleural effusion | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
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| weakness | General disorders | CTCAE (3.0) | Systematic Assessment |
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| fatigue | General disorders | CTCAE (3.0) | Systematic Assessment |
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| Bronchospasm | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Bowel perforation | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
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| Hyponatremia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
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| Hypokalemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
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| Weight loss | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
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| Pneumothorax | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Allergic reaction | Immune system disorders | CTCAE (3.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Apar Ganti | University of Nebraska Medical Center | 402-559-5622 | aganti@unmc.edu |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D017239 | Paclitaxel |
| D013660 | Taxes |
| D000077235 | Vinorelbine |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D004467 | Economics |
| D004472 | Health Care Economics and Organizations |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
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