Combination Chemotherapy and Exisulind in Treating Patients With Extensive-Stage Small Cell Lung Cancer
NCT ID: NCT00041054
Last Updated: 2016-12-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
41 participants
INTERVENTIONAL
2002-06-30
2008-02-29
Brief Summary
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PURPOSE: Phase II trial to study the effectiveness of combining chemotherapy with exisulind in treating patients who have extensive-stage small cell lung cancer.
Detailed Description
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* 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.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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carboplatin + etoposide + exisulind
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.
carboplatin
etoposide
exisulind
Interventions
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carboplatin
etoposide
exisulind
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Alliance for Clinical Trials in Oncology
OTHER
Responsible Party
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Principal Investigators
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Ramaswamy Govindan, MD
Role: STUDY_CHAIR
Washington University Siteman Cancer Center
Locations
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Northeast Alabama Regional Medical Center
Anniston, Alabama, United States
Rebecca and John Moores UCSD Cancer Center
La Jolla, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
Veterans Affairs Medical Center - San Diego
San Diego, California, United States
UCSF Comprehensive Cancer Center
San Francisco, California, United States
Veterans Affairs Medical Center - San Francisco
San Francisco, California, United States
CCOP - Christiana Care Health Services
Newark, Delaware, United States
Lombardi Cancer Center
Washington D.C., District of Columbia, United States
Walter Reed Army Medical Center
Washington D.C., District of Columbia, United States
Veterans Affairs Medical Center - Washington, DC
Washington D.C., District of Columbia, United States
Broward General Medical Center
Fort Lauderdale, Florida, United States
Memorial Regional Hospital Comprehensive Cancer Center
Hollywood, Florida, United States
CCOP - Mount Sinai Medical Center
Miami Beach, Florida, United States
Florida Hospital Cancer Institute
Orlando, Florida, United States
Helen and Harry Gray Cancer Institute at Good Samaritan Medical Center
West Palm Beach, Florida, United States
MBCCOP - University of Illinois at Chicago
Chicago, Illinois, United States
Veterans Affairs Medical Center - Chicago (Westside Hospital)
Chicago, Illinois, United States
University of Chicago Cancer Research Center
Chicago, Illinois, United States
Louis A. Weiss Memorial Hospital
Chicago, Illinois, United States
West Suburban Center for Cancer Care
River Forest, Illinois, United States
Saint Anthony Medical Center
Rockford, Illinois, United States
Fort Wayne Medical Oncology and Hematology, Incorporated
Fort Wayne, Indiana, United States
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, United States
Hematology Oncology Associates of the Quad Cities
Bettendorf, Iowa, United States
Holden Comprehensive Cancer Center
Iowa City, Iowa, United States
Baptist Hospital East - Louisville
Louisville, Kentucky, United States
Marlene and Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, United States
Veterans Affairs Medical Center - Baltimore
Baltimore, Maryland, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
University of Massachusetts Memorial Medical Center - University Campus
Worcester, Massachusetts, United States
Lakeland Medical Center - St. Joseph
Saint Joseph, Michigan, United States
Veterans Affairs Medical Center - Minneapolis
Minneapolis, Minnesota, United States
University of Minnesota Cancer Center
Minneapolis, Minnesota, United States
Veterans Affairs Medical Center - Columbia (Truman Memorial)
Columbia, Missouri, United States
Ellis Fischel Cancer Center - Columbia
Columbia, Missouri, United States
Barnes-Jewish Hospital
St Louis, Missouri, United States
Siteman Cancer Center
St Louis, Missouri, United States
Missouri Baptist Cancer Center
St Louis, Missouri, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, United States
Veterans Affairs Medical Center - Las Vegas
Las Vegas, Nevada, United States
Norris Cotton Cancer Center
Lebanon, New Hampshire, United States
Cooper University Hospital
Camden, New Jersey, United States
Veterans Affairs Medical Center - Buffalo
Buffalo, New York, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Elmhurst Hospital Center
Elmhurst, New York, United States
Queens Cancer Center of Queens Hospital
Jamaica, New York, United States
CCOP - North Shore University Hospital
Manhasset, New York, United States
North Shore University Hospital
Manhasset, New York, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Weill Medical College of Cornell University
New York, New York, United States
Mount Sinai Medical Center, NY
New York, New York, United States
State University of New York - Upstate Medical University
Syracuse, New York, United States
Veterans Affairs Medical Center - Syracuse
Syracuse, New York, United States
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
Syracuse, New York, United States
Veterans Affairs Medical Center - Asheville
Asheville, North Carolina, United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, United States
NorthEast Oncology Associates
Concord, North Carolina, United States
Veterans Affairs Medical Center - Durham
Durham, North Carolina, United States
Duke Comprehensive Cancer Center
Durham, North Carolina, United States
Cape Fear Valley Health System
Fayetteville, North Carolina, United States
Lenoir Memorial Hospital Cancer Center
Kinston, North Carolina, United States
FirstHealth Moore Regional Hospital
Pinehurst, North Carolina, United States
New Hanover Regional Medical Center
Wilmington, North Carolina, United States
CCOP - Southeast Cancer Control Consortium
Winston-Salem, North Carolina, United States
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, United States
Veterans Affairs Medical Center - Fargo
Fargo, North Dakota, United States
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, United States
Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, United States
Lifespan: The Miriam Hospital
Providence, Rhode Island, United States
Veterans Affairs Medical Center - Dallas
Dallas, Texas, United States
Simmons Cancer Center - Dallas
Dallas, Texas, United States
Green Mountain Oncology Group
Bennington, Vermont, United States
Vermont Cancer Center
Burlington, Vermont, United States
Veterans Affairs Medical Center - White River Junction
White River Junction, Vermont, United States
Martha Jefferson Hospital
Charlottesville, Virginia, United States
Virginia Oncology Associates - Norfolk
Norfolk, Virginia, United States
MBCCOP - Massey Cancer Center
Richmond, Virginia, United States
Oncology and Hematology Associates of Southwest Virginia, Inc.
Roanoke, Virginia, United States
St. Mary's Medical Center
Huntington, West Virginia, United States
Ministry Medical Group - Northern Region
Rhinelander, Wisconsin, United States
McGill University
Montreal, Quebec, Canada
University of Puerto Rico School of Medicine Medical Sciences Campus
San Juan, , Puerto Rico
Countries
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References
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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.
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.
Other Identifiers
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CLB-30104
Identifier Type: -
Identifier Source: secondary_id
CDR0000069439
Identifier Type: REGISTRY
Identifier Source: secondary_id
CALGB-30104
Identifier Type: -
Identifier Source: org_study_id