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| ID | Type | Description | Link |
|---|---|---|---|
| CLB-30104 | |||
| CDR0000069439 | 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. Exisulind may make tumor cells more sensitive to chemotherapy. Combining chemotherapy with exisulind may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining chemotherapy with exisulind in treating patients who have extensive-stage small cell lung cancer.
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients receive carboplatin IV over 30 minutes on day 1 and etoposide IV over 30-60 minutes on days 1-3. Patients also receive oral exisulind twice daily on days 1-21. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 2 months for 1 year and then every 4 months for 2 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| carboplatin + etoposide + exisulind | Experimental | Patients receive carboplatin IV over 30 minutes on day 1 and etoposide IV over 30-60 minutes on days 1-3. Patients also receive oral exisulind twice daily on days 1-21. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 months for 1 year and then every 4 months for 2 years. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| carboplatin | Drug |
| ||
| etoposide |
| Measure | Description | Time Frame |
|---|---|---|
| percentage of patients with extensive stage small cell lung cancer who live more than 12 months after treatment | Up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| response rate | Up to 3 years |
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DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed small cell lung cancer
At least 1 unidimensionally measurable lesion
At least 20 mm by conventional techniques OR
At least 10 mm by spiral CT scan
Lesions considered nonmeasurable include:
Must not be considered for combined chemotherapy and radiotherapy
No active CNS metastases
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
No concurrent hormonal agents except:
Radiotherapy:
Surgery:
Other:
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| Name | Affiliation | Role |
|---|---|---|
| Ramaswamy Govindan, MD | Washington University Siteman Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northeast Alabama Regional Medical Center | Anniston | Alabama | 36207 | United States | ||
| Rebecca and John Moores UCSD Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19179900 | Result | Govindan R, Wang X, Baggstrom MQ, Burdette-Radoux S, Hodgson L, Vokes EE, Green MR; Cancer and Leukemia Group B. A phase II study of carboplatin, etoposide, and exisulind in patients with extensive small cell lung cancer: CALGB 30104. J Thorac Oncol. 2009 Feb;4(2):220-6. doi: 10.1097/JTO.0b013e3181951eb0. | |
| 18976472 | Derived |
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|
| exisulind | Drug |
|
| La Jolla |
| California |
| 92093-0658 |
| United States |
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | United States |
| Veterans Affairs Medical Center - San Diego | San Diego | California | 92161 | United States |
| UCSF Comprehensive Cancer Center | San Francisco | California | 94115 | United States |
| Veterans Affairs Medical Center - San Francisco | San Francisco | California | 94121 | United States |
| CCOP - Christiana Care Health Services | Newark | Delaware | 19713 | 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 |
| Veterans Affairs Medical Center - Washington, DC | Washington D.C. | District of Columbia | 20422 | United States |
| Broward General Medical Center | Fort Lauderdale | Florida | 33316 | United States |
| Memorial Regional Hospital Comprehensive Cancer Center | Hollywood | Florida | 33021 | United States |
| CCOP - Mount Sinai Medical Center | Miami Beach | Florida | 33140 | United States |
| Florida Hospital Cancer Institute | Orlando | Florida | 32804 | United States |
| Helen and Harry Gray Cancer Institute at Good Samaritan Medical Center | West Palm Beach | Florida | 33401 | United States |
| MBCCOP - University of Illinois at Chicago | Chicago | Illinois | 60612-7323 | 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 |
| Louis A. Weiss Memorial Hospital | Chicago | Illinois | 60640 | United States |
| West Suburban Center for Cancer Care | River Forest | Illinois | 60305 | United States |
| Saint Anthony Medical Center | Rockford | Illinois | 61108 | United States |
| Fort Wayne Medical Oncology and Hematology, Incorporated | Fort Wayne | Indiana | 46885-5099 | United States |
| CCOP - Northern Indiana CR Consortium | South Bend | Indiana | 46601 | United States |
| Hematology Oncology Associates of the Quad Cities | Bettendorf | Iowa | 52722 | United States |
| Holden Comprehensive Cancer Center | Iowa City | Iowa | 52242-1009 | United States |
| Baptist Hospital East - Louisville | Louisville | Kentucky | 40207 | United States |
| Marlene and Stewart Greenebaum Cancer Center, University of Maryland | Baltimore | Maryland | 21201 | United States |
| Veterans Affairs Medical Center - Baltimore | 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 |
| Lakeland Medical Center - St. Joseph | Saint Joseph | Michigan | 49085 | 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 |
| Siteman Cancer Center | 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 |
| Veterans Affairs Medical Center - Las Vegas | Las Vegas | Nevada | 89106 | United States |
| Norris Cotton Cancer Center | Lebanon | New Hampshire | 03756-0002 | United States |
| Cooper University Hospital | Camden | New Jersey | 08103 | United States |
| Veterans Affairs Medical Center - Buffalo | Buffalo | New York | 14215 | United States |
| Roswell Park Cancer Institute | Buffalo | New York | 14263-0001 | United States |
| Elmhurst Hospital Center | Elmhurst | New York | 11373 | United States |
| Queens Cancer Center of Queens Hospital | Jamaica | New York | 11432 | 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 |
| Weill Medical College of Cornell University | 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 |
| Veterans Affairs Medical Center - Asheville | Asheville | North Carolina | 28805 | United States |
| Lineberger Comprehensive Cancer Center, UNC | Chapel Hill | North Carolina | 27599-7295 | United States |
| NorthEast Oncology Associates | Concord | North Carolina | 28025 | United States |
| Veterans Affairs Medical Center - Durham | Durham | North Carolina | 27705 | United States |
| Duke Comprehensive Cancer Center | Durham | North Carolina | 27710 | United States |
| Cape Fear Valley Health System | Fayetteville | North Carolina | 28302-2000 | United States |
| Lenoir Memorial Hospital Cancer Center | Kinston | North Carolina | 28503-1678 | United States |
| FirstHealth Moore Regional Hospital | Pinehurst | North Carolina | 28374 | United States |
| New Hanover Regional Medical Center | Wilmington | North Carolina | 28402-9025 | 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 |
| Veterans Affairs Medical Center - Fargo | Fargo | North Dakota | 58102 | United States |
| Arthur G. James Cancer Hospital - Ohio State University | Columbus | Ohio | 43210-1240 | United States |
| Western Pennsylvania Hospital | Pittsburgh | Pennsylvania | 15224 | United States |
| Lifespan: The Miriam Hospital | Providence | Rhode Island | 02906 | United States |
| Veterans Affairs Medical Center - Dallas | Dallas | Texas | 75216 | United States |
| Simmons Cancer Center - Dallas | Dallas | Texas | 75235-9154 | 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 |
| Martha Jefferson Hospital | Charlottesville | Virginia | 22901 | United States |
| Virginia Oncology Associates - Norfolk | Norfolk | Virginia | 23502 | United States |
| MBCCOP - Massey Cancer Center | Richmond | Virginia | 23298-0037 | United States |
| Oncology and Hematology Associates of Southwest Virginia, Inc. | Roanoke | Virginia | 24014 | United States |
| St. Mary's Medical Center | Huntington | West Virginia | 25701 | United States |
| Ministry Medical Group - Northern Region | Rhinelander | Wisconsin | 54501 | United States |
| McGill University | Montreal | Quebec | H2W 1S6 | Canada |
| University of Puerto Rico School of Medicine Medical Sciences Campus | San Juan | 00936-5067 | Puerto Rico |
| Hanna M, Thipphawong J; 118 Study Group. A randomized, double-blind comparison of OROS(R) hydromorphone and controlled-release morphine for the control of chronic cancer pain. BMC Palliat Care. 2008 Oct 31;7:17. doi: 10.1186/1472-684X-7-17. |
| 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 |
|---|---|
| D016190 | Carboplatin |
| D005047 | Etoposide |
| C025463 | sulindac sulfone |
| ID | Term |
|---|---|
| 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 |
| D002241 | Carbohydrates |
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