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Home > "C" Clinical Trials Conditions > Combination Chemotherapy and Exisulind in Treating Patients With Extensive-Stage Small Cell Lung Cancer

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



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

For Condition: extensive stage small cell lung cancer
Status: Completed
Sponsor(s): Cancer and Leukemia Group B , National Cancer Institute (NCI)
Synopsis: 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.
Details: 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. PROJECTED ACCRUAL: A total of 41 patients will be accrued for this study within 8 months.
Eligibility:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: 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
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
RamaswamyGovindan,  Study Chair,  Washington University Siteman Cancer Center

Memorial Sloan-Kettering Cancer Center
New York City,  New York,  10021
United States
 

Veterans Affairs Medical Center - Durham
Durham,  North Carolina,  27705
United States
 

University of Puerto Rico School of Medicine Medical Sciences Campus
San Juan,  ,  00936-5067
Puerto Rico
 

Veterans Affairs Medical Center - White River Junction
White River Junction,  Vermont,  05009
United States
 

Virginia Oncology Associates - Norfolk
Norfolk,  Virginia,  23502
United States
 

McGill University
Montreal,  Quebec,  H2W 1S6
Canada
 

Fort Wayne Medical Oncology and Hematology, Incorporated
Ft. Wayne,  Indiana,  46885-5099
United States
 

Lenoir Memorial Hospital Cancer Center
Kinston,  North Carolina,  28503-1678
United States
 

Barnes-Jewish Hospital
St. Louis,  Missouri,  63110
United States
 

St. Mary's Medical Center
Huntington,  West Virginia,  25701
United States
 

Memorial Regional Hospital Comprehensive Cancer Center
Hollywood,  Florida,  33021
United States
 

Weill Medical College of Cornell University
New York City,  New York,  10021
United States
 

Ellis Fischel Cancer Center - Columbia
Columbia,  Missouri,  65203
United States
 

Simmons Cancer Center - Dallas
Dallas,  Texas,  75235-9154
United States
 

Duke Comprehensive Cancer Center
Durham,  North Carolina,  27710
United States
 

Oncology and Hematology Associates of Southwest Virginia, Inc.
Roanoke,  Virginia,  24014
United States
 

Lineberger Comprehensive Cancer Center, UNC
Chapel Hill,  North Carolina,  27599-7295
United States
 

Marlene and Stewart Greenebaum Cancer Center, University of Maryland
Baltimore,  Maryland,  21201
United States
 

Veterans Affairs Medical Center - San Francisco
San Francisco,  California,  94121
United States
 

Elmhurst Hospital Center
Elmhurst,  New York,  11373
United States
 

MBCCOP - University of Illinois at Chicago
Chicago,  Illinois,  60612-7323
United States
 

Norris Cotton Cancer Center
Lebanon,  New Hampshire,  03756-0002
United States
 

Veterans Affairs Medical Center - Columbia (Truman Memorial)
Columbia,  Missouri,  65201
United States
 

Mount Sinai Medical Center, NY
New York City,  New York,  10029
United States
 

Lakeland Medical Center - St. Joseph
Saint Joseph,  Michigan,  49085
United States
 

West Suburban Center for Cancer Care
River Forest,  Illinois,  60305
United States
 

Hematology Oncology Associates of the Quad Cities
Bettendorf,  Iowa,  52722
United States
 

CCOP - North Shore University Hospital
Manhasset,  New York,  11030
United States
 

Veterans Affairs Medical Center - San Diego
San Diego,  California,  92161
United States
 

CCOP - Southeast Cancer Control Consortium
Winston Salem,  North Carolina,  27104-4241
United States
 

Lombardi Cancer Center
Washington D.C.,  District of Columbia,  20007
United States
 

Helen and Harry Gray Cancer Institute at Good Samaritan Medical Center
West Palm Beach,  Florida,  33401
United States
 

Louis A. Weiss Memorial Hospital
Chicago,  Illinois,  60640
United States
 

Lifespan: The Miriam Hospital
Providence,  Rhode Island,  02906
United States
 

Veterans Affairs Medical Center - Buffalo
Buffalo,  New York,  14215
United States
 

Veterans Affairs Medical Center - Fargo
Fargo,  North Dakota,  58102
United States
 

NorthEast Oncology Associates
Concord,  North Carolina,  28025
United States
 

MBCCOP - Massey Cancer Center
Richmond,  Virginia,  23298-0037
United States
 

University of Minnesota Cancer Center
Minneapolis,  Minnesota,  55455
United States
 

Missouri Baptist Cancer Center
St. Louis,  Missouri,  63131
United States
 

Vermont Cancer Center
Burlington,  Vermont,  05401-3498
United States
 

University of Nebraska Medical Center
Omaha,  Nebraska,  68198-7680
United States
 

University of Massachusetts Memorial Medical Center - University Campus
Worcester,  Massachusetts,  01655
United States
 

Veterans Affairs Medical Center - Dallas
Dallas,  Texas,  75216
United States
 

Florida Hospital Cancer Institute
Orlando,  Florida,  32804
United States
 

Western Pennsylvania Hospital
Pittsburgh,  Pennsylvania,  15224
United States
 

North Shore University Hospital
Manhasset,  New York,  11030
United States
 

UCSF Comprehensive Cancer Center
San Francisco,  California,  94115
United States
 

Veterans Affairs Medical Center - Baltimore
Baltimore,  Maryland,  21201
United States
 

FirstHealth Moore Regional Hospital
Pinehurst,  North Carolina,  28374
United States
 

Veterans Affairs Medical Center - Chicago (Westside Hospital)
Chicago,  Illinois,  60612
United States
 

Queens Cancer Center of Queens Hospital
Jamaica,  New York,  11432
United States
 

Northeast Alabama Regional Medical Center
Anniston,  Alabama,  36207
United States
 

Cedars-Sinai Medical Center
Los Angeles,  California,  90048
United States
 

University of Chicago Cancer Research Center
Chicago,  Illinois,  60637-1470
United States
 

Dana-Farber Cancer Institute
Boston,  Massachusetts,  02115
United States
 

Siteman Cancer Center
St. Louis,  Missouri,  63110
United States
 

CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
Syracuse,  New York,  13217
United States
 

Roswell Park Cancer Institute
Buffalo,  New York,  14263-0001
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
 

Cape Fear Valley Health System
Fayetteville,  North Carolina,  28302-2000
United States
 

CCOP - Mount Sinai Medical Center
Miami,  Florida,  33140
United States
 

State University of New York - Upstate Medical University
Syracuse,  New York,  13210
United States
 

Holden Comprehensive Cancer Center
Iowa City,  Iowa,  52242-1009
United States
 

Veterans Affairs Medical Center - Washington, DC
Washington D.C.,  District of Columbia,  20422
United States
 

Arthur G. James Cancer Hospital - Ohio State University
Columbus,  Ohio,  43210-1240
United States
 

Ministry Medical Group - Northern Region
Rhinelander,  Wisconsin,  54501
United States
 

Martha Jefferson Hospital
Charlottesville,  Virginia,  22901
United States
 

Veterans Affairs Medical Center - Minneapolis
Minneapolis,  Minnesota,  55417
United States
 

Saint Anthony Medical Center
Rockford,  Illinois,  61108
United States
 

New Hanover Regional Medical Center
Wilmington,  North Carolina,  28402-9025
United States
 

Veterans Affairs Medical Center - Syracuse
Syracuse,  New York,  13210
United States
 

Comprehensive Cancer Center at Wake Forest University
Winston Salem,  North Carolina,  27157-1082
United States
 

Rebecca and John Moores UCSD Cancer Center
La Jolla,  California,  92093-0658
United States
 

CCOP - Christiana Care Health Services
Newark,  Delaware,  19713
United States
 

Cooper University Hospital
Camden,  New Jersey,  08103
United States
 

Green Mountain Oncology Group
Bennington,  Vermont,  05201
United States
 

Baptist Hospital East - Louisville
Louisville,  Kentucky,  40207
United States
 

Walter Reed Army Medical Center
Washington D.C.,  District of Columbia,  20307-5000
United States
 

CCOP - Northern Indiana CR Consortium
South Bend,  Indiana,  46601
United States
 

Broward General Medical Center
Ft. Lauderdale,  Florida,  33316
United States
 

Veterans Affairs Medical Center - Asheville
Asheville,  North Carolina,  28805
United States
 


Additional Information:
Study ID Numbers:
  CDR0000069439;  CLB-30104
Study Start Date: 
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00041054

Other Extensive Stage Small Cell Lung Cancer Studies:
1. BBR 3464 in Treating Patients With Metastatic Small Cell Lung Cancer That Has Not Responded to Previous Treatment

2. Cisplatin Plus Etoposide With or Without Paclitaxel in Treating Patients With Extensive-Stage Small Cell Lung Cancer

3. Combination Chemotherapy With or Without Filgrastim in Treating Patients With Previously Untreated Extensive-Stage Small Cell Lung Cancer

4. Cisplatin, Etoposide, and Bevacizumab in Treating Patients With Previously Untreated Extensive-Stage Small Cell Lung Cancer

5. Phase I/II Study of Lepirudin in Patients with Recurrent or Extensive Stage Small Cell Lung Cancer

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

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