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| ID | Type | Description | Link |
|---|---|---|---|
| U10CA031946 | U.S. NIH Grant/Contract | View source | |
| CLB-30002 | |||
| CDR0000069313 | 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 use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy and radiation therapy may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and radiation therapy in treating patients who have limited-stage small cell lung cancer.
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients with rapid disease progression discontinue study therapy.
Patients are followed at least every 3 months for 2 years, every 6 months for 3 years, and then annually for 5 years.
PROJECTED ACCRUAL: A total of 25-60 patients will be accrued for this study within 10 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| chemotherapy + radiation therapy | Experimental | Induction therapy: Patients receive paclitaxel IV over 3 hours on days 1 and 22, oral topotecan on days 2-4 and 23-25, and oral etoposide on days 5-7 and 26-28. Patients also receive filgrastim (G-CSF) subcutaneously daily beginning on days 8 and 29 and continuing until blood counts recover. Consolidation therapy: Patients receive carboplatin IV over 1 hour on days 43, 64, and 85 and etoposide IV over 1 hour on days 43-45, 64-66, and 85-87. Patients undergo radiotherapy daily 5 days per week beginning on day 43 and continuing for 6-7 weeks. Patients with rapid disease progression discontinue study therapy. Patients are followed at least every 3 months for 2 years, every 6 months for 3 years, and then annually for 5 years. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| filgrastim | Biological |
| ||
| carboplatin |
| Measure | Description | Time Frame |
|---|---|---|
| overall response rate | up to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| failure-free survival | up to 5 years | |
| overall survival | up to 5 years |
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DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed small cell lung cancer
Measurable disease
At least 20 mm by conventional techniques OR
At least 10 mm by spiral CT scan
Lesions not considered measurable include the following:
No clinically suspected or confirmed supraclavicular lymph node metastases
No pleural effusions visible on plain chest radiographs, regardless of cytology
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
No concurrent hormonal therapy except:
Radiotherapy:
Surgery:
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| Name | Affiliation | Role |
|---|---|---|
| Antonius A. Miller, MD | Wake Forest University Health Sciences | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Veterans Affairs Medical Center - Birmingham | Birmingham | Alabama | 35233-1996 | United States | ||
| University of California San Diego Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17607121 | Result | Miller AA, Wang XF, Bogart JA, Hodgson LD, Rocha Lima CM, Radford JE, Vokes EE, Green MR; Cancer and Leukemia Group B (CALGB). Phase II trial of paclitaxel-topotecan-etoposide followed by consolidation chemoradiotherapy for limited-stage small cell lung cancer: CALGB 30002. J Thorac Oncol. 2007 Jul;2(7):645-51. doi: 10.1097/JTO.0b013e318074bbf5. |
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|
| etoposide | Drug |
|
| paclitaxel | Drug |
|
| topotecan hydrochloride | Drug |
|
| radiation therapy | Radiation |
|
| La Jolla |
| California |
| 92093-0658 |
| United States |
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | United States |
| Veterans Affairs Medical Center - San Francisco | San Francisco | California | 94121 | United States |
| UCSF Cancer Center and Cancer Research Institute | San Francisco | California | 94143-0128 | United States |
| CCOP - Christiana Care Health Services | Wilmington | Delaware | 19899 | United States |
| Lombardi Cancer Center | Washington D.C. | District of Columbia | 20007 | United States |
| Walter Reed Army Medical Center | Washington D.C. | District of Columbia | 20307-5000 | United States |
| CCOP - Mount Sinai Medical Center | Miami Beach | Florida | 33140 | United States |
| Veterans Affairs Medical Center - Chicago (Westside Hospital) | Chicago | Illinois | 60612 | United States |
| University of Chicago Cancer Research Center | Chicago | Illinois | 60637-1470 | United States |
| CCOP - Northern Indiana CR Consortium | South Bend | Indiana | 46601 | United States |
| Holden Comprehensive Cancer Center | Iowa City | Iowa | 52242-1009 | United States |
| Veterans Affairs Medical Center - Togus | Togus | Maine | 04330 | United States |
| Marlene and Stewart Greenebaum Cancer Center, University of Maryland | Baltimore | Maryland | 21201 | United States |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02115 | United States |
| University of Massachusetts Memorial Medical Center - University Campus | Worcester | Massachusetts | 01655 | United States |
| Veterans Affairs Medical Center - Minneapolis | Minneapolis | Minnesota | 55417 | United States |
| University of Minnesota Cancer Center | Minneapolis | Minnesota | 55455 | United States |
| Veterans Affairs Medical Center - Columbia (Truman Memorial) | Columbia | Missouri | 65201 | United States |
| Ellis Fischel Cancer Center - Columbia | Columbia | Missouri | 65203 | United States |
| Barnes-Jewish Hospital | St Louis | Missouri | 63110 | United States |
| Missouri Baptist Cancer Center | St Louis | Missouri | 63131 | United States |
| University of Nebraska Medical Center | Omaha | Nebraska | 68198-7680 | United States |
| CCOP - Southern Nevada Cancer Research Foundation | Las Vegas | Nevada | 89106 | United States |
| Norris Cotton Cancer Center | Lebanon | New Hampshire | 03756-0002 | United States |
| Veterans Affairs Medical Center - Buffalo | Buffalo | New York | 14215 | United States |
| Roswell Park Cancer Institute | Buffalo | New York | 14263-0001 | United States |
| CCOP - North Shore University Hospital | Manhasset | New York | 11030 | United States |
| North Shore University Hospital | Manhasset | New York | 11030 | United States |
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10021 | United States |
| New York Presbyterian Hospital - Cornell Campus | New York | New York | 10021 | United States |
| Mount Sinai Medical Center, NY | New York | New York | 10029 | United States |
| State University of New York - Upstate Medical University | Syracuse | New York | 13210 | United States |
| Veterans Affairs Medical Center - Syracuse | Syracuse | New York | 13210 | United States |
| CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. | Syracuse | New York | 13217 | United States |
| Lineberger Comprehensive Cancer Center, UNC | Chapel Hill | North Carolina | 27599-7295 | United States |
| Veterans Affairs Medical Center - Durham | Durham | North Carolina | 27705 | United States |
| Duke Comprehensive Cancer Center | Durham | North Carolina | 27710 | United States |
| CCOP - Southeast Cancer Control Consortium | Winston-Salem | North Carolina | 27104-4241 | United States |
| Comprehensive Cancer Center at Wake Forest University | Winston-Salem | North Carolina | 27157-1082 | United States |
| Arthur G. James Cancer Hospital - Ohio State University | Columbus | Ohio | 43210-1240 | United States |
| Western Pennsylvania Hospital | Pittsburgh | Pennsylvania | 15224 | United States |
| Rhode Island Hospital | Providence | Rhode Island | 02903 | United States |
| University of Tennessee Cancer Institute | Memphis | Tennessee | 38103 | United States |
| Veterans Affairs Medical Center - Memphis | Memphis | Tennessee | 38104 | United States |
| Green Mountain Oncology Group | Bennington | Vermont | 05201 | United States |
| Vermont Cancer Center | Burlington | Vermont | 05401-3498 | United States |
| Veterans Affairs Medical Center - White River Junction | White River Junction | Vermont | 05009 | United States |
| Veterans Affairs Medical Center - Richmond | Richmond | Virginia | 23249 | United States |
| MBCCOP - Massey Cancer Center | Richmond | Virginia | 23298-0037 | United States |
| 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 |
|---|---|
| D000069585 | Filgrastim |
| D016190 | Carboplatin |
| D005047 | Etoposide |
| D017239 | Paclitaxel |
| D019772 | Topotecan |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D016179 | Granulocyte Colony-Stimulating Factor |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D013812 | Therapeutics |
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