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Combination Chemotherapy Plus Filgrastim in Treating Patients With Previously Untreated Extensive-Stage Small Cell Lung Cancer



Combination Chemotherapy Plus Filgrastim in Treating Patients With Previously Untreated Extensive-Stage Small Cell Lung Cancer

For Condition: extensive stage small cell lung cancer
Status: Completed
Sponsor(s): National Cancer Institute (NCI) , Southwest Oncology Group
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. Colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus filgrastim in treating patients who have previously untreated extensive-stage small cell lung cancer.
Details: OBJECTIVES: I. Assess the survival and response rate of patients with previously untreated extensive stage small cell lung cancer treated with paclitaxel, carboplatin, topotecan, and filgrastim (G-CSF). II. Determine the side effects and toxicity of this regimen in these patients. PROTOCOL OUTLINE: Patients receive topotecan IV over 30 minutes on days 1-4 and paclitaxel IV over 1 hour followed by carboplatin IV over 1 hour prior to topotecan on day 4. Patients receive filgrastim (G-CSF) subcutaneously once daily beginning on day 5 and continuing until blood counts recover. G-CSF must be discontinued at least 24 hours prior to beginning each subsequent course of chemotherapy. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 6 months for 3 years. PROJECTED ACCRUAL: A total of 75 patients will be accrued for this study over 18 months.
Eligibility:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: 
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically or cytologically proven, previously untreated extensive stage small cell lung cancer (SCLC) - Brain metastases allowed if: Asymptomatic OR Previously treated with radiotherapy and/or surgery - Measurable or evaluable disease outside the area of prior surgical resection or a new lesion must be present --Prior/Concurrent Therapy-- - Biologic therapy: No prior systemic biologic therapy for SCLC - Chemotherapy: No prior systemic chemotherapy for SCLC - Endocrine therapy: Not specified - Radiotherapy: See Disease Characteristics; No prior radiotherapy for SCLC - Surgery: See Disease Characteristics; At least 2 weeks since prior thoracic or other major surgery and recovered --Patient Characteristics-- - Age: 18 and over - Performance status: SWOG 0-2 - Life expectancy: Not specified - Hematopoietic: Absolute granulocyte count at least 1,500/mm3; WBC at least 3,000/mm3; Platelet count at least 100,000/mm3 - Hepatic: Bilirubin no greater than 1.25 times upper limit of normal (ULN); SGOT or SGPT no greater than 2.5 times ULN - Renal: Creatinine no greater than ULN; Creatinine clearance at least 50 mL/min - Other: Not pregnant or nursing; Fertile patients must use effective contraception; No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or any stage I or II cancer that is in complete remission
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
FrankDunphy,  Study Chair,  Southwest Oncology Group

Cleveland Clinic Taussig Cancer Center
Cleveland,  Ohio,  44195
United States
 

Boston Medical Center
Boston,  Massachusetts,  02118
United States
 

USC/Norris Comprehensive Cancer Center
Los Angeles,  California,  90033-0800
United States
 

Texas Tech University Health Science Center
Lubbock,  Texas,  79423
United States
 

CCOP - Wichita
Wichita,  Kansas,  67214-3882
United States
 

Brooke Army Medical Center
Fort Sam Houston,  Texas,  78234
United States
 

Oklahoma Medical Research Foundation
Oklahoma City,  Oklahoma,  73104
United States
 

Oregon Cancer Institute at Oregon Health and Science University
Portland,  Oregon,  97201-3098
United States
 

Veterans Affairs Medical Center - Shreveport
Shreveport,  Louisiana,  71130
United States
 

Veterans Affairs Outpatient Clinic - Martinez
Martinez,  California,  94553
United States
 

University of Texas Health Science Center at San Antonio
San Antonio,  Texas,  78284-7811
United States
 

Tulane University School of Medicine
New Orleans,  Louisiana,  70112
United States
 

CCOP - Grand Rapids Clinical Oncology Program
Grand Rapids,  Michigan,  49503
United States
 

Veterans Affairs Medical Center - Kansas City
Kansas City,  Missouri,  64128
United States
 

CCOP - Atlanta Regional
Atlanta,  Georgia,  30342-1701
United States
 

Veterans Affairs Medical Center - Salt Lake City
Salt Lake City,  Utah,  84148
United States
 

Henry Ford Hospital
Detroit,  Michigan,  48202
United States
 

CCOP - Montana Cancer Consortium
Billings,  Montana,  59101
United States
 

MBCCOP - Gulf Coast
Mobile,  Alabama,  36652
United States
 

Chao Family Comprehensive Cancer Center
Orange,  California,  92868
United States
 

Veterans Affairs Medical Center - Ann Arbor
Ann Arbor,  Michigan,  48105
United States
 

MBCCOP - University of New Mexico HSC
Albuquerque,  New Mexico,  87131
United States
 

CCOP - Columbus
Columbus,  Ohio,  43206
United States
 

Veterans Affairs Medical Center - Wichita
Wichita,  Kansas,  67218
United States
 

Barrett Cancer Center, The University Hospital
Cincinnati,  Ohio,  45219
United States
 

CCOP - Northwest
Tacoma,  Washington,  98405-0986
United States
 

Herbert Irving Comprehensive Cancer Center
New York City,  New York,  10032
United States
 

University of Arkansas for Medical Sciences
Little Rock,  Arkansas,  72205
United States
 

Cancer Research Center of Hawaii
Honolulu,  Hawaii,  96813
United States
 

CCOP - Santa Rosa Memorial Hospital
Santa Rosa,  California,  95403
United States
 

Arizona Cancer Center
Tucson,  Arizona,  85724
United States
 

University of Colorado Cancer Center
Denver,  Colorado,  80262
United States
 

CCOP - Bay Area Tumor Institute
Oakland,  California,  94609-3305
United States
 

Veterans Affairs Medical Center - New Orleans
New Orleans,  Louisiana,  70112
United States
 

Veterans Affairs Medical Center - Lexington
Lexington,  Kentucky,  40511-1093
United States
 

Veterans Affairs Medical Center - Phoenix (Hayden)
Phoenix,  Arizona,  85012
United States
 

Jonsson Comprehensive Cancer Center, UCLA
Los Angeles,  California,  90095-1781
United States
 

CCOP - Central Illinois
Decatur,  Illinois,  62526
United States
 

CCOP - Kansas City
Kansas City,  Missouri,  64131
United States
 

CCOP - Upstate Carolina
Spartanburg,  South Carolina,  29303
United States
 

Dwight David Eisenhower Army Medical Center
Fort Gordon,  Georgia,  30905-5650
United States
 

Veterans Affairs Medical Center - Long Beach
Long Beach,  California,  90822
United States
 

CCOP - St. Louis-Cape Girardeau
St. Louis,  Missouri,  63141
United States
 

St. Elizabeth's Medical Center
Boston,  Massachusetts,  02135-2997
United States
 

Veterans Affairs Medical Center - Portland
Portland,  Oregon,  97207
United States
 

Veterans Affairs Medical Center - Dayton
Dayton,  Ohio,  45428
United States
 

University of Michigan Comprehensive Cancer Center
Ann Arbor,  Michigan,  48109-0752
United States
 

CCOP - Virginia Mason Research Center
Seattle,  Washington,  98101
United States
 

Veterans Affairs Medical Center - Seattle
Seattle,  Washington,  98108
United States
 

Veterans Affairs Medical Center - Denver
Denver,  Colorado,  80220
United States
 

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

University of Mississippi Medical Center
Jackson,  Mississippi,  39216-4505
United States
 

Albert B. Chandler Medical Center, University of Kentucky
Lexington,  Kentucky,  40536-0084
United States
 

Veterans Affairs Medical Center - Boston (Jamaica Plain)
Jamaica Plain,  Massachusetts,  02130
United States
 

Veterans Affairs Medical Center - Tucson
Tucson,  Arizona,  85723
United States
 

Veterans Affairs Medical Center - Little Rock (McClellan)
Little Rock,  Arkansas,  72205
United States
 

David Grant Medical Center
Travis Air Force Base,  California,  94535
United States
 

MBCCOP - LSU Health Sciences Center
New Orleans,  Louisiana,  70112
United States
 

University of Kansas Medical Center
Kansas City,  Kansas,  66160-7357
United States
 

Loyola University Medical Center
Maywood,  Illinois,  60153
United States
 

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

Veterans Affairs Medical Center - Oklahoma City
Oklahoma City,  Oklahoma,  73104
United States
 

CCOP - Columbia River Program
Portland,  Oregon,  97213
United States
 

CCOP - Scott and White Hospital
Temple,  Texas,  76508
United States
 

Veterans Affairs Medical Center - San Antonio (Murphy)
San Antonio,  Texas,  78284
United States
 

Louisiana State University Health Sciences Center - Shreveport
Shreveport,  Louisiana,  71130-3932
United States
 

CCOP - Greater Phoenix
Phoenix,  Arizona,  85006-2726
United States
 

Providence Hospital - Southfield
Southfield,  Michigan,  48075-9975
United States
 

CCOP - Cancer Research for the Ozarks
Springfield,  Missouri,  65807
United States
 

Veterans Affairs Medical Center - Biloxi
Biloxi,  Mississippi,  39531-2410
United States
 

University of California Davis Medical Center
Sacramento,  California,  95817
United States
 

Veterans Affairs Medical Center - Temple
Temple,  Texas,  76504
United States
 

Barbara Ann Karmanos Cancer Institute
Detroit,  Michigan,  48201
United States
 

CCOP - Dayton
Kettering,  Ohio,  45429
United States
 

Swedish Cancer Institute
Seattle,  Washington,  98104
United States
 

Veterans Affairs Medical Center - Jackson
Jackson,  Mississippi,  39216
United States
 

CCOP - Greenville
Greenville,  South Carolina,  29615
United States
 

Veterans Affairs Medical Center - Albuquerque
Albuquerque,  New Mexico,  87108-5138
United States
 

Beckman Research Institute, City of Hope
Los Angeles,  California,  91010
United States
 

Huntsman Cancer Institute
Salt Lake City,  Utah,  84132
United States
 

Veterans Affairs Medical Center - Detroit
Detroit,  Michigan,  48201-1932
United States
 

Keesler Medical Center - Keesler AFB
Keesler AFB,  Mississippi,  39534-2576
United States
 

Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
Hines,  Illinois,  60141
United States
 

University of Texas Medical Branch
Galveston,  Texas,  77555-0209
United States
 

Veterans Affairs Medical Center - Cincinnati
Cincinnati,  Ohio,  45220-2288
United States
 


Additional Information:
Study ID Numbers:
  CDR0000067367;  SWOG-S9914
Study Start Date: October 1999
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004137

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2. Combination Chemotherapy With or Without Oblimersen in Treating Patients With Extensive-Stage Small Cell Lung Cancer

3. Combination Chemotherapy in Treating Patients With Extensive-Stage Small Cell Lung Cancer

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

5. Combination Chemotherapy in Treating Patients With Extensive-Stage Small Cell Lung Cancer

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