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| Name | Class |
|---|---|
| Sanofi | INDUSTRY |
The purpose of this study is to determine whether a combination of the drugs docetaxel (Taxotere ® ), plus vinorelbine (Navelbine ® ), will result in fewer side effects than cisplatin chemotherapy, thereby improving delivery of chemotherapy in patients.
Another purpose of this study is to determine whether a third drug, bevacizumab (Avastin®), may be delivered safely with docetaxel plus vinorelbine in patients who are eligible to receive bevacizumab.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Docetaxel (Taxotere), Vinorelbine, and Bevacizumab, as Adjuvant Chemotherapy for Patients with Resected Stage I-III Non-small Cell Lung Cancer |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bevacizumab (Avastin), Taxotere (Docetaxel), Vinorelbine Tartrate (Navelbine) | Drug | Patients will be treated as follows: vinorelbine (45 mg/m2) + docetaxel (45 mg/m2) intravenously on day 1, followed by pegylated filgrastim 6mg subcutaneously on day 2, delivered every 2 weeks for 8 doses total. Patients who have already received one cycle of cisplatin-based adjuvant chemotherapy need only complete 3 cycles of vinorelbine+docetaxel for a total of 4 cycles of adjuvant chemotherapy. Patients who require post-operative radiation therapy (PORT) will begin PORT after completion of vinorelbine + docetaxel. |
| Measure | Description | Time Frame |
|---|---|---|
| To Measure the Number of Cycles | Cycle delivery is a surrogate for drug delivery. Both cycle delivery and drug delivery will be measured in this study. However, cycle delivery (up to 4 cycles) is the common way drug delivery is measured in the literature, and therefore cycle delivery has been chosen as the primary endpoint for this study.Two doses of both docetaxel plus vinorelbine, delivered over 4 weeks, constitutes one cycle. If either drug is discontinued, the subject will remain on study, however that patient will not get credit for completing subsequent cycles of therapy. If the dose of either drug is reduced, the subject will remain on study and get credit for subsequent cycles. | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christopher Azzoli, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan-Kettering at Basking Ridge | Basking Ridge | New Jersey | 07920 | United States | ||
| Memorial Sloan-Kettering Cancer Center @ Suffolk |
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| Label | URL |
|---|---|
| Memorial Sloan-Kettering Cancer Center | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Docetaxel (Taxotere®) Plus Vinorelbine | Docetaxel (Taxotere®) plus Vinorelbine as Adjuvant Chemotherapy for Patients with Resected Stage I-III Non-small Cell Lung Cancer |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| Commack |
| New York |
| 11725 |
| United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| Memorial Sloan-Kettering at Mercy Medical Center | Rockville Centre | New York | United States |
| Memorial Sloan-Kettering Cancer Center at Phelps Memorial Hospital Center | Sleepy Hollow | New York | 10591 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Docetaxel (Taxotere®) Plus Vinorelbine | Docetaxel (Taxotere®) plus Vinorelbine as Adjuvant Chemotherapy for Patients with Resected Stage I-III Non-small Cell Lung Cancer |
| 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 |
|
| 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 | To Measure the Number of Cycles | Cycle delivery is a surrogate for drug delivery. Both cycle delivery and drug delivery will be measured in this study. However, cycle delivery (up to 4 cycles) is the common way drug delivery is measured in the literature, and therefore cycle delivery has been chosen as the primary endpoint for this study.Two doses of both docetaxel plus vinorelbine, delivered over 4 weeks, constitutes one cycle. If either drug is discontinued, the subject will remain on study, however that patient will not get credit for completing subsequent cycles of therapy. If the dose of either drug is reduced, the subject will remain on study and get credit for subsequent cycles. | Posted | Number | participants | 2 years |
|
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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 | Docetaxel (Taxotere®) Plus Vinorelbine | Docetaxel (Taxotere®) plus Vinorelbine as Adjuvant Chemotherapy for Patients with Resected Stage I-III Non-small Cell Lung Cancer | 13 | 23 | 23 | 23 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | General disorders | CTC-3.0 | Systematic Assessment |
| |
| Atrial tachycardia/Paroxysmal Atrial Tachycardia | Cardiac disorders | CTC-3.0 | Systematic Assessment |
| |
| Dermatology/Skin, other | Skin and subcutaneous tissue disorders | CTC-3.0 | Systematic Assessment |
| |
| Fatigue (asthenia, lethargy, malaise) | General disorders | CTC-3.0 | Systematic Assessment |
| |
| Febrile neutropenia | General disorders | CTC-3.0 | Systematic Assessment |
| |
| Hemoglobin | Blood and lymphatic system disorders | CTC-3.0 | Systematic Assessment |
| |
| Inf norm ANC/gr1/2 neut-Catheter-related | Blood and lymphatic system disorders | CTC-3.0 | Systematic Assessment |
| |
| Inf unknown ANC-Ungual(nails) | Infections and infestations | CTC-3.0 | Systematic Assessment |
| |
| Infection, other | Infections and infestations | CTC-3.0 | Systematic Assessment |
| |
| Leukocytes (total WBC) | Blood and lymphatic system disorders | CTC-3.0 | Systematic Assessment |
| |
| Mucositis (func/sympt)- Oral cavity | General disorders | CTC-3.0 | Systematic Assessment |
| |
| Neutrophils/granulocytes (ANC/AGC) | Blood and lymphatic system disorders | CTC-3.0 | Systematic Assessment |
| |
| Pain - Abdomen NOS | General disorders | CTC-3.0 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | CTC-3.0 | Systematic Assessment |
| |
| Sodium, low (hyponatremia) | Metabolism and nutrition disorders | CTC-3.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | CTC-3.0 | Systematic Assessment |
| |
| Neuropathy | Nervous system disorders | CTC-3.0 | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTC-3.0 | Systematic Assessment |
| |
| ALT, SGPT | Blood and lymphatic system disorders | CTC-3.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTC-3.0 | Systematic Assessment |
| |
| Cough | General disorders | CTC-3.0 | Systematic Assessment |
| |
| Dyspnea (shortness of breath) | Respiratory, thoracic and mediastinal disorders | CTC-3.0 | Systematic Assessment |
| |
| Fever (in the absence of neutropenia) | General disorders | CTC-3.0 | Systematic Assessment |
| |
| Glucose, high (hyperglycemia) | Metabolism and nutrition disorders | CTC-3.0 | Systematic Assessment |
| |
| Hair loss/alopecia (scalp or body) | General disorders | CTC-3.0 | Systematic Assessment |
| |
| Hemoglobin | Blood and lymphatic system disorders | CTC-3.0 | Systematic Assessment |
| |
| Leukocytes (total WBC) | Blood and lymphatic system disorders | CTC-3.0 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | CTC-3.0 | Systematic Assessment |
| |
| Mucositis (Clin exam)- Oral cavity | General disorders | CTC-3.0 | Systematic Assessment |
| |
| Nail changes | Skin and subcutaneous tissue disorders | CTC-3.0 | Systematic Assessment |
| |
| Nausea | General disorders | CTC-3.0 | Systematic Assessment |
| |
| Neutrophils/granulocytes (ANC/AGC) | Blood and lymphatic system disorders | CTC-3.0 | Systematic Assessment |
| |
| Pain - Other | General disorders | CTC-3.0 | Systematic Assessment |
| |
| Phosphate, low (hypophosphatemia) | Metabolism and nutrition disorders | CTC-3.0 | Systematic Assessment |
| |
| Rash/desquamation | Skin and subcutaneous tissue disorders | CTC-3.0 | Systematic Assessment |
| |
| Rash: erythema multiforme | Skin and subcutaneous tissue disorders | CTC-3.0 | Systematic Assessment |
| |
| Watery eye (epiphora, tearing) | Eye disorders | CTC-3.0 | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Mark G. Kris | Memorial Sloan Kettering Cancer Center | 646-888-4205 | Krism@mskcc.org |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| 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 |
|---|---|
| D000068258 | Bevacizumab |
| D000077143 | Docetaxel |
| D000077235 | Vinorelbine |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| 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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