Combination Chemotherapy and Exisulind in Treating Patients With Extensive-Stage Small Cell Lung Cancer



Status:Completed
Conditions:Lung Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:June 2002
End Date:February 2008

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A Phase II Study of Carboplatin, Etoposide, and Exisulind in Patients With Extensive Small Cell Lung Cancer

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:

- Determine the percentage of patients with extensive stage small cell lung cancer who
live more than 12 months after treatment with carboplatin, etoposide, and exisulind.

- Determine the response rate of patients treated with this regimen.

- Determine the toxicity of this regimen in these patients.

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.

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:

- Bone lesions

- Leptomeningeal disease

- Ascites

- Pleural/pericardial effusion

- Abdominal masses that are not confirmed and followed by imaging techniques

- Cystic lesions

- Tumor lesions situated in a previously irradiated area

- Must not be considered for combined chemotherapy and radiotherapy

- No active CNS metastases

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- ECOG 0-2

Life expectancy:

- Not specified

Hematopoietic:

- Granulocyte count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3

Hepatic:

- Bilirubin normal

- AST no greater than 2 times ULN

- No clinically significant hepatic disease

Renal:

- Creatinine no greater than 2.0 mg/dL OR

- Creatinine clearance at least 60 mL/min

- No clinically significant renal disease

Cardiovascular:

- No clinically significant cardiac disease

Other:

- Not pregnant or nursing

- Fertile patients must use effective contraception

- No concurrent uncontrolled illness

- No known sensitivity to sulindac

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- See Disease Characteristics

- No prior chemotherapy for small cell lung cancer

- No other concurrent chemotherapy

Endocrine therapy:

- No concurrent hormonal agents except:

- Steroids for adrenal failure

- Hormones for nondisease-related conditions (e.g., insulin for diabetes)

- Intermittent use of dexamethasone as an antiemetic

Radiotherapy:

- See Disease Characteristics

- At least 2 weeks since prior radiotherapy, including for palliation

- No concurrent radiotherapy

Surgery:

- Not specified

Other:

- More than 7 days since prior sulindac

- No concurrent sulindac
We found this trial at
82
sites
Norfolk, Virginia 23502
2341
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Norfolk, VA
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666 Elm Street
Buffalo, New York 14263
(716) 845-2300
Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
2181
mi
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Buffalo, NY
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125 Science Dr
Durham, North Carolina 27710
888.275.3853
Duke Comprehensive Cancer Center Leading-edge cancer care and research have been a hallmark of Duke...
2202
mi
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Durham, NC
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8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
13
mi
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Los Angeles, CA
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300 Community Drive
Manhasset, New York 11030
2448
mi
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Manhasset, NY
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300 Community Drive
Manhasset, New York 11030
(516) 562-0100
North Shore University Hospital North Shore-LIJ Health System includes 16 award-winning hospitals and nearly 400...
2448
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Manhasset, NY
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4300 Alton Road
Miami Beach, Florida 33140
(305) 674-2625
CCOP - Mount Sinai Medical Center The Mount Sinai Community Clinical Oncology Program (MSCCOP) is...
2323
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Miami Beach, FL
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1839
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Anniston, AL
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Asheville, North Carolina 28805
2005
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Asheville, NC
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2301
mi
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Baltimore, MD
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2301
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Baltimore, MD
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Bennington, Vermont 05201
2468
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Bennington, VT
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1351 Kimberly Rd
Bettendorf, Iowa 52722
(563) 355-7733
Hematology Oncology Associates of the Quad Cities
1580
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Bettendorf, IA
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
2578
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Boston, MA
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2184
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Buffalo, NY
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Burlington, Vermont 05405
2467
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Burlington, VT
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1 Cooper Plaza
Camden, New Jersey 08103
(856) 342-2000
Cooper University Hospital Cooper University Health Care, the clinical campus of Cooper Medical School of...
2377
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Camden, NJ
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Chapel Hill, North Carolina 27599
2194
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Chapel Hill, NC
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Charlottesville, Virginia 22901
2208
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Charlottesville, VA
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1726
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Chicago, IL
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Chicago, IL
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Chicago, IL
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Chicago, Illinois 60640
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Chicago, IL
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1459
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Columbia, MO
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Columbia, Missouri 65203
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1959
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Columbus, OH
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Concord, North Carolina 28025
2115
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Concord, NC
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1225
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Dallas, TX
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Dallas, Texas 75235
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Durham, North Carolina 27705
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Elmhurst, New York 11373
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Elmhurst, NY
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Fargo, North Dakota 58102
1415
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Fargo, ND
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Fayetteville, North Carolina 28304
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Fort Lauderdale, Florida 33316
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1855
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Fort Wayne, IN
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Hollywood, FL
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Huntington, West Virginia 25702
1996
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Huntington, WV
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Iowa City, Iowa 52242
1528
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Iowa City, IA
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Jamaica, New York 11432
2443
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Kinston, North Carolina 28503
2283
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Kinston, NC
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La Jolla, California 92093
93
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La Jolla, CA
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217
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Las Vegas, NV
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217
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Las Vegas, NV
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Lebanon, New Hampshire 03756
2515
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Louisville, Kentucky 40207
1818
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Minneapolis, Minnesota 55417
1509
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Minneapolis, Minnesota 55455
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Montreal, Quebec
2452
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Montreal,
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New York, New York 10029
2435
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1275 York Ave
New York, New York 10021
(212) 639-2000
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
2434
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New York, NY
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445 E 69th St
New York, New York 10021
(212) 746-1067
Weill Medical College of Cornell University Founded in 1898, and affiliated with what is now...
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New York, NY
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4701 Ogletown-Stanton Road
Newark, Delaware 19713
302-623-4450
CCOP - Christiana Care Health Services Christiana Care's Cancer Research Program is part of a...
2347
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Newark, DE
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Emile St
Omaha, Nebraska 68198
(402) 559-4000
Univ of Nebraska Med Ctr A vital enterprise in the nation’s heartland, the University of...
1300
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Orlando, Florida 32804
2182
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Pinehurst, North Carolina 28374
2178
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4800 Friendship Ave
Pittsburgh, Pennsylvania 15224
(412) 578-5000
Western Pennsylvania Hospital Featuring 308 private patient beds, West Penn Hospital has served Bloomfield and...
2121
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Providence, Rhode Island 02906
2563
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Rhinelander, Wisconsin 54501
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Richmond, Virginia 23298
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River Forest, Illinois 60305
1720
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2133
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Roanoke, VA
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Rockford, Illinois 61108
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Saint Joseph, Michigan 49085
1789
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Saint Joseph, MI
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Saint Louis, Missouri 63110
1569
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Saint Louis, Missouri 63110
1570
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Saint Louis, MO
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3015 N Ballas Rd
Saint Louis, Missouri 63131
(314) 996-5151
Missouri Baptist Cancer Center The Cancer Center at Missouri Baptist is a member of Heartland...
1560
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Saint Louis, MO
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San Diego, California 92161
94
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San Francisco, California 94115
356
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San Francisco, California 94121
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South Bend, Indiana 46601
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Washington, District of Columbia 20007
2279
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6900 Georgia Ave NW
Washington, District of Columbia 20307
(202) 782-6849
Walter Reed Army Medical Center The Walter Reed National Military Medical Center is one of...
2281
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Washington, District of Columbia 20422
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2304
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West Palm Beach, FL
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White River Junction, Vermont 05009
2511
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White River Junction, VT
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Wilmington, North Carolina 28401
2275
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Wilmington, NC
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Winston-Salem, North Carolina 27104
2122
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Winston-Salem, NC
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Medical Center Boulevard
Winston-Salem, North Carolina 27157
336-716-2255
Comprehensive Cancer Center of Wake Forest University Our newly expanded Comprehensive Cancer Center is the...
2129
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Winston-Salem, NC
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2542
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Worcester, MA
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