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| ID | Type | Description | Link |
|---|---|---|---|
| CALGB-30506 | |||
| CDR0000636895 | Registry Identifier | NCI Physician Data Query |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Drugs used in chemotherapy, such as vinorelbine, cisplatin, docetaxel, gemcitabine, and pemetrexed disodium, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Sometimes after surgery, the tumor may not need more treatment until it progresses. In this case, observation may be sufficient. It is not yet known whether chemotherapy is more effective than observation in treating patients who have undergone surgery for stage I non-small cell lung cancer.
PURPOSE: This randomized phase III trial is studying four chemotherapy regimens to see how well they work compared with observation in treating patients with early stage non-small cell lung cancer.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study. Patients are stratified according to pathologic stage (I vs II) and ECOG performance status (0 vs 1). Patients are randomized to 1 of 2 treatment arms within 12 weeks after surgery.
All patients undergo complete resection of disease (i.e., lobectomy, sleeve lobectomy, bi-lobectomy, or pneumonectomy, but not segmentectomy or wedge resection).
Arm I: Patients receive 1 of 3 chemotherapy regimens. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
Arm II: Patients receive standard care (observation). Tissue obtained at surgery is examined by RNA microarray analysis. A Lung Metagene Score (LMS) is determined for each patient and correlated with survival and response.
After completion of study treatment, patients are followed every 6 months for 5 years and then once a year for 7 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I | Experimental | Patients receive cisplatin IV on day 1 and vinorelbine ditartrate IV on days 1 and 8 OR docetaxel IV and cytarabine IV on day 1 OR gemcitabine hydrochloride IV on days 1 and 8 and cytarabine IV on day 1 OR pemetrexed disodium IV and cisplatin IV on day 1.. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. |
|
| Arm II | Experimental | Patients receive standard care (observation). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cisplatin | Drug | Given IV |
| |
| docetaxel |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Overall survival (OS) is defined as the time between formal registration and death from any cause. The median OS with 95% CI was estimated using the Kaplan-Meier method. | Up to 12 years |
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DISEASE CHARACTERISTICS:
Histologically confirmed non-small cell lung cancer
Tumor measuring ≥ 2.0 cm but ≤ 7.0 cm in diameter by CT scan
Node-negative disease
No locally advanced or metastatic disease
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| David H. Harpole, MD | Duke Cancer Institute | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Regional Medical Center | Anniston | Alabama | 36207 | United States | ||
| UAB Comprehensive Cancer Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm I (Chemotherapy) | Patients receive cisplatin 75 mg/m^2 by IV on day 1 and vinorelbine ditartrate 30 mg/m^2 by IV on days 1 and 8 OR docetaxel 75 mg/m^2 by IV and cisplatin 75 mg/m^2 by IV on day 1 OR gemcitabine hydrochloride 1200 mg/m^2 by IV on days 1 and 8 and cisplatin 75 mg/m^2 by IV on day 1 OR pemetrexed disodium 500 mg/m^2 by IV and 75 mg/m^2 by cisplatin IV on day 1. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Drug |
Given IV |
|
| gemcitabine hydrochloride | Drug | Given IV |
|
| pemetrexed disodium | Drug | Given IV |
|
| vinorelbine tartrate | Drug | Given IV |
|
| standard follow-up care | Procedure | Standard care |
|
| Birmingham |
| Alabama |
| 35294 |
| United States |
| Roy and Patricia Disney Family Cancer Center at Providence Saint Joseph Medical Center | Burbank | California | 91505 | United States |
| Glendale Memorial Hospital Comprehensive Cancer Center | Glendale | California | 91204 | United States |
| Rebecca and John Moores UCSD Cancer Center | La Jolla | California | 92093-0658 | United States |
| Pismo Beach | California | 93449 | United States |
| Robert and Beverly Lewis Family Cancer Care Center at Pomona Valley Hospital Medical Center | Pomona | California | 91767 | United States |
| Helen and Harry Gray Cancer Center at Hartford Hospital | Hartford | Connecticut | 06102-5037 | United States |
| Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital | Fort Lauderdale | Florida | 33308 | United States |
| Memorial Cancer Institute at Memorial Regional Hospital | Hollywood | Florida | 33021 | United States |
| Ella Milbank Foshay Cancer Center at Jupiter Medical Center | Jupiter | Florida | 33458 | United States |
| CCOP - Mount Sinai Medical Center | Miami Beach | Florida | 33140 | United States |
| Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler | Savannah | Georgia | 31405 | United States |
| Resurrection Medical Center | Chicago | Illinois | 60631 | United States |
| University of Chicago Cancer Research Center | Chicago | Illinois | 60637-1470 | United States |
| Elkhart Clinic, LLC | Elkhart | Indiana | 46514-2098 | United States |
| Michiana Hematology-Oncology, PC - Elkhart | Elkhart | Indiana | 46514 | United States |
| Elkhart General Hospital | Elkhart | Indiana | 46515 | United States |
| Howard Community Hospital | Kokomo | Indiana | 46904 | United States |
| Center for Cancer Therapy at LaPorte Hospital and Health Services | La Porte | Indiana | 46350 | United States |
| Michiana Hematology-Oncology, PC - South Bend | Mishawaka | Indiana | 46545-1470 | United States |
| Saint Joseph Regional Medical Center | Mishawaka | Indiana | 46545-1470 | United States |
| Michiana Hematology Oncology PC - Plymouth | Plymouth | Indiana | 46563 | United States |
| CCOP - Northern Indiana CR Consortium | South Bend | Indiana | 46601 | United States |
| Memorial Hospital of South Bend | South Bend | Indiana | 46601 | United States |
| Michiana Hematology Oncology PC - La Porte | Westville | Indiana | 46391 | United States |
| Cedar Rapids Oncology Associates | Cedar Rapids | Iowa | 52403 | United States |
| Mercy Regional Cancer Center at Mercy Medical Center | Cedar Rapids | Iowa | 52403 | United States |
| Central Baptist Hospital | Lexington | Kentucky | 40503-9985 | United States |
| Lucille P. Markey Cancer Center at University of Kentucky | Lexington | Kentucky | 40536-0093 | United States |
| Mary Bird Perkins Cancer Center - Baton Rouge | Baton Rouge | Louisiana | 70809 | United States |
| Maine Center for Cancer Medicine and Blood Disorders - Scarborough | Scarborough | Maine | 04074 | United States |
| Greater Baltimore Medical Center Cancer Center | Baltimore | Maryland | 21204 | United States |
| Alvin and Lois Lapidus Cancer Institute at Sinai Hospital | Baltimore | Maryland | 21215 | United States |
| Cancer Institute at St. Joseph Medical Center | Towson | Maryland | 21204 | United States |
| Dana-Farber/Brigham and Women's Cancer Center | Boston | Massachusetts | 02115 | United States |
| Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute | Boston | Massachusetts | 02115 | United States |
| Newton-Wellesley Hospital | Newton | Massachusetts | 02462 | United States |
| Green Bay Oncology, Limited - Escanaba | Escanaba | Michigan | 49431 | United States |
| Dickinson County Healthcare System | Iron Mountain | Michigan | 49801 | United States |
| Borgess Medical Center | Kalamazoo | Michigan | 49001 | United States |
| West Michigan Cancer Center | Kalamazoo | Michigan | 49007-3731 | United States |
| Bronson Methodist Hospital | Kalamazoo | Michigan | 49007 | United States |
| Michiana Hematology Oncology PC - Niles | Niles | Michigan | 49120 | United States |
| William Beaumont Hospital - Royal Oak Campus | Royal Oak | Michigan | 48073 | United States |
| Lakeland Regional Cancer Care Center - St. Joseph | Saint Joseph | Michigan | 49085 | United States |
| Lakeside Cancer Specialists, PLLC | Saint Joseph | Michigan | 49085 | United States |
| Cancer Resource Center - Lincoln | Lincoln | Nebraska | 68510 | United States |
| CCOP - Missouri Valley Cancer Consortium | Omaha | Nebraska | 68106 | United States |
| Methodist Estabrook Cancer Center | Omaha | Nebraska | 68114 | United States |
| Immanuel Medical Center | Omaha | Nebraska | 68122 | United States |
| Alegant Health Cancer Center at Bergan Mercy Medical Center | Omaha | Nebraska | 68124 | United States |
| Creighton University Medical Center | Omaha | Nebraska | 68131-2197 | United States |
| New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care | Concord | New Hampshire | 03301 | United States |
| New Hampshire Oncology - Hematology, PA - Hooksett | Hooksett | New Hampshire | 03106 | United States |
| Saint Francis Hospital Cancer Center | Poughkeepsie | New York | 12601 | United States |
| SUNY Upstate Medical University Hospital | Syracuse | New York | 13210 | United States |
| Faxton Regional Cancer Center | Utica | New York | 13502 | United States |
| Duke Comprehensive Cancer Center | Durham | North Carolina | 27710 | United States |
| Wayne Memorial Hospital, Incorporated | Goldsboro | North Carolina | 27534 | United States |
| Kinston Medical Specialists | Kinston | North Carolina | 28501 | United States |
| Wake Forest University Comprehensive Cancer Center | Winston-Salem | North Carolina | 27157-1096 | United States |
| Mercy Cancer Center at Mercy Medical Center | Canton | Ohio | 44708 | United States |
| Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43210-1240 | United States |
| Natalie Warren Bryant Cancer Center at St. Francis Hospital | Tulsa | Oklahoma | 74136 | United States |
| Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest | Allentown | Pennsylvania | 18105 | United States |
| St. Luke's Cancer Network at St. Luke's Hospital | Bethlehem | Pennsylvania | 18015 | United States |
| Easton Regional Cancer Center at Easton Hospital | Easton | Pennsylvania | 18042 | United States |
| Lancaster General Hospital | Lancaster | Pennsylvania | 17604 | United States |
| Jameson Memorial Hospital - North Campus | New Castle | Pennsylvania | 16105 | United States |
| Allegheny Cancer Center at Allegheny General Hospital | Pittsburgh | Pennsylvania | 15212 | United States |
| UPMC Cancer Centers | Pittsburgh | Pennsylvania | 15232 | United States |
| Medical City Dallas Hospital | Dallas | Texas | 75230 | United States |
| University of Virginia Cancer Center | Charlottesville | Virginia | 22908 | United States |
| Lynchburg Hematology-Oncology Clinic | Lynchburg | Virginia | 24501 | United States |
| Providence Centralia Hospital | Centralia | Washington | 98531-9027 | United States |
| St. Francis Hospital | Federal Way | Washington | 98003 | United States |
| Providence St. Peter Hospital Regional Cancer Center | Olympia | Washington | 98506-5166 | United States |
| Good Samaritan Cancer Center | Puyallup | Washington | 98372 | United States |
| Franciscan Cancer Center at St. Joseph Medical Center | Tacoma | Washington | 98405-3004 | United States |
| Allenmore Hospital | Tacoma | Washington | 98405 | United States |
| CCOP - Northwest | Tacoma | Washington | 98405 | United States |
| MultiCare Regional Cancer Center at Tacoma General Hospital | Tacoma | Washington | 98405 | United States |
| St. Clare Hospital | Tacoma | Washington | 98499 | United States |
| Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center | Green Bay | Wisconsin | 54301-3526 | United States |
| Green Bay Oncology, Limited at St. Mary's Hospital | Green Bay | Wisconsin | 54303 | United States |
| St. Mary's Hospital Medical Center - Green Bay | Green Bay | Wisconsin | 54303 | United States |
| St. Vincent Hospital Regional Cancer Center | Green Bay | Wisconsin | 54307-3508 | United States |
| Holy Family Memorial Medical Center Cancer Care Center | Manitowoc | Wisconsin | 54221-1450 | United States |
| Bay Area Cancer Care Center at Bay Area Medical Center | Marinette | Wisconsin | 54143 | United States |
| Green Bay Oncology, Limited - Oconto Falls | Oconto Falls | Wisconsin | 54154 | United States |
| St. Nicholas Hospital | Sheboygan | Wisconsin | 53081 | United States |
| Green Bay Oncology, Limited - Sturgeon Bay | Sturgeon Bay | Wisconsin | 54235 | United States |
| St. Vincent's Hospital - Melbourne | Fitzroy | Victoria | 3065 | Australia |
| FG001 | Arm II (Observation) | Patients receive standard care (observation). |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Arm I (Chemotherapy) | Patients receive cisplatin 75 mg/m^2 by IV on day 1 and vinorelbine ditartrate 30 mg/m^2 by IV on days 1 and 8 OR docetaxel 75 mg/m^2 by IV and cisplatin 75 mg/m^2 by IV on day 1 OR gemcitabine hydrochloride 1200 mg/m^2 by IV on days 1 and 8 and cisplatin 75 mg/m^2 by IV on day 1 OR pemetrexed disodium 500 mg/m^2 by IV and 75 mg/m^2 by cisplatin IV on day 1. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. |
| BG001 | Arm II (Observation) | Patients receive standard care (observation). |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | 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 Survival | Overall survival (OS) is defined as the time between formal registration and death from any cause. The median OS with 95% CI was estimated using the Kaplan-Meier method. | Study terminated prematurely with 34 participants recruited. Per protocol, 338 events were needed to conduct the primary analysis; therefore, the planned analyses was not performed due to a lack of events and a termination of data collection. | Posted | Up to 12 years |
|
|
Not provided
Data is available on 8 participants recruited to Arm I. Adverse event reporting was not required, per protocol, for participants on Arm II (observation); therefore, there are no adverse event data to report for this arm.
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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 | Arm II (Observation) | Patients receive standard care (observation). | 0 | 0 | 0 | 0 | ||
| EG001 | Arm I (Chemotherapy) | Patients receive cisplatin 75 mg/m^2 by IV on day 1 and vinorelbine ditartrate 30 mg/m^2 by IV on days 1 and 8 OR docetaxel 75 mg/m^2 by IV and cisplatin 75 mg/m^2 by IV on day 1 OR gemcitabine hydrochloride 1200 mg/m^2 by IV on days 1 and 8 and cisplatin 75 mg/m^2 by IV on day 1 OR pemetrexed disodium 500 mg/m^2 by IV and 75 mg/m^2 by cisplatin IV on day 1. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. | 2 | 8 | 5 | 8 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 6 | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA 6 | Systematic Assessment |
| |
| Eye disorders - Other, specify | Eye disorders | MedDRA 6 | Systematic Assessment |
| |
| Mucositis oral | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Infections and infestations - Other, specify | Infections and infestations | MedDRA 6 | Systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
| |
| Hypophosphatemia | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
| |
| Nervous system disorders - Other, specify | Nervous system disorders | MedDRA 6 | Systematic Assessment |
| |
| Adult respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 6 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 6 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hearing impaired | Ear and labyrinth disorders | MedDRA 6 | Systematic Assessment |
| |
| Mucositis oral | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 6 | Systematic Assessment |
| |
| Creatinine increased | Investigations | MedDRA 6 | Systematic Assessment |
| |
| Investigations - Other, specify | Investigations | MedDRA 6 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 6 | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 6 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 6 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 6 | Systematic Assessment |
| |
| Peripheral motor neuropathy | Nervous system disorders | MedDRA 6 | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 6 | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David Harpole, M.D. | Duke University Medical Center | david.harpole@duke.edu |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D000077192 | Adenocarcinoma of Lung |
| D002282 | Adenocarcinoma, Bronchiolo-Alveolar |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D002945 | Cisplatin |
| D000077143 | Docetaxel |
| D000093542 | Gemcitabine |
| D000068437 | Pemetrexed |
| D000077235 | Vinorelbine |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D005971 | Glutamates |
| D024342 | Amino Acids, Acidic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000600 | Amino Acids, Dicarboxylic |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D007211 | Indoles |
| D054836 | Indolizidines |
| D007212 | Indolizines |
Not provided
Not provided
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|