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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2010-00606 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 5R21CA123866-02 | 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 how well fludeoxyglucose F 18 (FDG)-labeled positron emission tomography (PET) scan works in planning chemotherapy in treating patients with stage IIIB or IV non-small cell lung cancer (NSCLC). Drugs used in chemotherapy, such as paclitaxel, carboplatin, gemcitabine hydrochloride, and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Diagnostic imaging procedures, such as FDG-labeled PET scan, may help in guiding chemotherapy and allow doctors to plan better treatment
PRIMARY OBJECTIVES:
I. Assess the response rate in patients who do not demonstrate an early response to carboplatin/paclitaxel as determined by FDG-PET ("initial non-responders") who are subsequently treated with three additional courses of docetaxel/gemcitabine.
SECONDARY OBJECTIVES:
I. Evaluate the ability of FDG-PET to predict response to therapy as measured by computed tomography (CT).
II. Evaluate the early and late changes in tumor FDG uptake (change in standardized uptake value [SUV]) in all patients and correlate with overall survival (OS).
OUTLINE: All patients receive paclitaxel intravenously (IV) over 3 hours and carboplatin IV over 30 minutes on day 1. Patients undergo FDG-PET/CT scan between days 18-21.
Patients are then assigned to 1 of 2 treatment groups.
GROUP I (Responders): Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment repeats every 3 weeks for up to 3 additional courses in the absence of disease progression or unacceptable toxicity.
GROUP II (Initial non-responders): Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and docetaxel IV over 1 hour on day 8. Treatment repeats every 3 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients undergo FDG-PET/CT scan between days 18-21 of course 2.
After completion of study treatment, patients are followed up at days 81-84 and then periodically thereafter.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chemotherapy | Experimental | Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Patients undergo FDG PET/CT (fludeoxyglucose F 18 positron emission tomography/computed tomography) scan between days 18-21. The FDG PET/CT is an imaging biomarker analysis. Patients that are responding to treatment receive paclitaxel IV and carboplatin IV on day 1. Treatment repeats every 3 weeks for up to 3 additional courses in the absence of disease progression or unacceptable toxicity.Patients that are not responding to chemotherapy per FDG PET then receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and docetaxel IV over 1 hour on day 8. Treatment repeats every 3 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity. Non-responding patients undergo an additional FDG PET/CT scan between days 18-21 of course 2. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| carboplatin | Drug | Given IV |
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| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (Patients That Achieve a CR or PR) | Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) criteria. 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. | At the end of 4 cycles of treatment, up to 24 weeks. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Keith Eaton | Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Harborview Medical Center | Seattle | Washington | 98104 | United States | ||
| Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium |
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| ID | Title | Description |
|---|---|---|
| FG000 | Chemotherapy | Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Patients undergo FDG PET/CT scan between days 18-21. Patients that are responding to treatment receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment repeats every 3 weeks for up to 3 additional courses in the absence of disease progression or unacceptable toxicity.Patients then receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and docetaxel IV over 1 hour on day 8. Treatment repeats every 3 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients undergo FDG PET/CT scan between days 18-21 of course 2. carboplatin: Given IV docetaxel: Given IV gemcitabine hydrochloride: Given IV paclitaxel: Given IV computed tomography: Undergo FDG PET/CT positron emission tomography: Undergo FDG PET/CT fludeoxyglucose F 18: Given IV imaging biomarker analysis: Correlative studies |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| docetaxel | Drug | Given IV |
|
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| gemcitabine hydrochloride | Drug | Given IV |
|
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| paclitaxel | Drug | Given IV |
|
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| computed tomography | Procedure | Undergo FDG PET/CT |
|
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| positron emission tomography | Procedure | Undergo FDG PET/CT |
|
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| fludeoxyglucose F 18 | Radiation | Given IV |
|
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| imaging biomarker analysis | Other | Correlative studies |
|
| Seattle |
| Washington |
| 98109 |
| United States |
| COMPLETED |
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| NOT COMPLETED |
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All patients that signed consent and received at least one dose of chemotherapy.
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| ID | Title | Description |
|---|---|---|
| BG000 | Chemotherapy | Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Patients undergo FDG PET/CT scan between days 18-21. Patients that are responding to treatment receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment repeats every 3 weeks for up to 3 additional courses in the absence of disease progression or unacceptable toxicity.Patients then receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and docetaxel IV over 1 hour on day 8. Treatment repeats every 3 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients undergo FDG PET/CT scan between days 18-21 of course 2. carboplatin: Given IV docetaxel: Given IV gemcitabine hydrochloride: Given IV paclitaxel: Given IV computed tomography: Undergo FDG PET/CT positron emission tomography: Undergo FDG PET/CT fludeoxyglucose F 18: Given IV imaging biomarker analysis: Correlative studies |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Age, Continuous | Mean | Full Range | years |
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| Gender | Count of Participants | Participants |
| ||||||||||||||||||||
| Region of Enrollment | Number | 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 | Overall Response Rate (Patients That Achieve a CR or PR) | Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) criteria. 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. | All patients that signed consent and received at least one cycle of chemotherapy. | Posted | Number | participants | At the end of 4 cycles of treatment, up to 24 weeks. |
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Adverse events were collected from the time of signing the informed consent through 30 days after the final dose of chemotherapy, up to 24 weeks.
Only grade 3 and higher adverse events or adverse events that led to a dose reduction or dose delay were captured. Hospitalizations related to disease progression were not captured as serious adverse events.
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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 | Chemotherapy | Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Patients undergo FDG PET/CT scan between days 18-21. Patients that are responding to treatment receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment repeats every 3 weeks for up to 3 additional courses in the absence of disease progression or unacceptable toxicity.Patients then receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and docetaxel IV over 1 hour on day 8. Treatment repeats every 3 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients undergo FDG PET/CT scan between days 18-21 of course 2. carboplatin: Given IV docetaxel: Given IV gemcitabine hydrochloride: Given IV paclitaxel: Given IV computed tomography: Undergo FDG PET/CT positron emission tomography: Undergo FDG PET/CT fludeoxyglucose F 18: Given IV imaging biomarker analysis: Correlative studies | 3 | 46 | 20 | 46 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | CTC 3.0 | Systematic Assessment |
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| Sepsis | Infections and infestations | CTC 3.0 | Systematic Assessment |
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| Neutropenia | Investigations | CTC 3.0 | Systematic Assessment |
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| acute renal insufficiency | Renal and urinary disorders | CTC 3.0 | Systematic Assessment |
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| Hypercalcemia | Metabolism and nutrition disorders | CTC 3.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Increased ALT | Investigations | CTC 3.0 | Systematic Assessment |
| |
| Anemia | Blood and lymphatic system disorders | CTC 3.0 | Systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | CTC 3.0 | Systematic Assessment |
| |
| Thromboembolic Event | Vascular disorders | CTC 3.0 | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | CTC 3.0 | Systematic Assessment |
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| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTC 3.0 | Systematic Assessment |
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| Fatigue | General disorders | CTC 3.0 | Systematic Assessment |
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| Fever | General disorders | CTC 3.0 | Systematic Assessment |
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| Hypercalcemia | Metabolism and nutrition disorders | CTC 3.0 | Systematic Assessment |
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| Hypoalbuminemia | Metabolism and nutrition disorders | CTC 3.0 | Systematic Assessment |
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| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTC 3.0 | Systematic Assessment |
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| Anxiety | Psychiatric disorders | CTC 3.0 | Systematic Assessment |
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| Leukopenia | Blood and lymphatic system disorders | CTC 3.0 | Systematic Assessment |
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| Lymphocyte count decreased | Investigations | CTC 3.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | CTC 3.0 | Systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | CTC 3.0 | Systematic Assessment |
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| Pain- NOS | Musculoskeletal and connective tissue disorders | CTC 3.0 | Systematic Assessment |
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| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | CTC 3.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | CTC 3.0 | Systematic Assessment |
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| Syncope | Nervous system disorders | CTC 3.0 | Systematic Assessment |
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| Tachycardia | Cardiac disorders | CTC 3.0 | Systematic Assessment |
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| Thrombocytopenia | Investigations | CTC 3.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | CTC 3.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Keith D. Eaton, MD, PhD | University of Washington | 2062886249 | kdeaton@uw.edu |
| ID | Term |
|---|---|
| D016066 | Pleural Effusion, Malignant |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D010997 | Pleural Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010996 | Pleural Effusion |
| D010995 | Pleural Diseases |
| D012140 | Respiratory Tract Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| D016190 | Carboplatin |
| D000077143 | Docetaxel |
| D000093542 | Gemcitabine |
| D017239 | Paclitaxel |
| D013660 | Taxes |
| D009682 | Magnetic Resonance Spectroscopy |
| C062942 | 2-phenyl-6-(2'-(4'-(ethoxycarbonyl)thiazolyl))thiazolo(3,2-b)(1,2,4)triazole |
| D019788 | Fluorodeoxyglucose F18 |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D004467 | Economics |
| D004472 | Health Care Economics and Organizations |
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
| D003847 | Deoxyglucose |
| D003837 | Deoxy Sugars |
| D002241 | Carbohydrates |
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