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Home > "C" Clinical Trials Conditions > Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Limited-stage Small Cell Lung Cancer

Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Limited-stage Small Cell Lung Cancer



Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Limited-stage Small Cell Lung Cancer

For Condition: limited stage small cell lung cancer
Status: No longer recruiting
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. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining more than one chemotherapy drug with radiation therapy may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy plus radiation therapy in treating patients who have limited-stage small cell lung cancer.
Details: OBJECTIVES: I. Determine the feasibility of tirapazamine, cisplatin, and etoposide concurrently with radiotherapy in patients with limited stage small cell lung cancer. II. Determine the toxicities of this treatment regimen in these patients. III. Determine the response rate in these patients treated with this regimen. PROTOCOL OUTLINE: Patients are assigned to one of two induction therapy arms. Arm I: Patients receive induction chemotherapy consisting of low-dose tirapazamine IV over 1 hour and cisplatin IV over 1 hour on days 1, 8, 29, and 36 and etoposide IV over 1 hour on days 1-5 and 29-33. Patients also undergo radiotherapy concurrently with chemotherapy 5 consecutive days a week for 7 weeks beginning on day 1. Arm II: Patients receive induction chemotherapy consisting of high-dose tirapazamine, cisplatin, etoposide, and radiotherapy as in arm I. Patients with stable or responding disease then receive consolidation therapy consisting of tirapazamine IV over 1 hour and cisplatin IV over 1 hour on day 1 of weeks 11 and 14 and etoposide IV over 1 hour on days 1-3 of weeks 11 and 14. Patients are followed every 2 months for 1 year and then every 6 months for 2 years. PROJECTED ACCRUAL: A total of 50 patients (25 per arm) will be accrued for this study.
Eligibility:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: 
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically or cytologically confirmed limited stage small cell lung cancer (SCLC) - No malignant pericardial or pleural effusions, including: Cytologically positive effusions OR Exudative effusions not attributable to other etiologies - No brain metastases - Disease (measurable or non-measurable) must be present outside the area of prior surgical resection --Prior/Concurrent Therapy-- - Biologic therapy: No prior biologic therapy for SCLC - Chemotherapy: No prior systemic chemotherapy for SCLC - Endocrine therapy: Not specified - Radiotherapy: No prior thoracic 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: Zubrod 0-1 - Life expectancy: Not specified - Hematopoietic: Absolute neutrophil count greater than 1,500/mm3; Platelet count greater than 100,000/mm3 - Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN); SGOT or SGPT no greater than 2 times ULN; Alkaline phosphatase no greater than 2 times ULN - Renal: Creatinine no greater than ULN OR Creatinine clearance at least 60 mL/min - Other: Not pregnant or nursing; Fertile patients must use effective contraception; No symptomatic sensory neuropathy grade 1 or greater; No other malignancy within past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or other stage I or II cancer in complete remission; No other medical illness that would preclude study
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
Quynh-ThuLe,  Study Chair,  Southwest Oncology Group

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

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

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

Huntsman Cancer Institute
Salt Lake City,  Utah,  84112
United States
 

Henry Ford Hospital
Detroit,  Michigan,  48202
United States
 

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

USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles,  California,  90033-0804
United States
 

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

St. Louis University Health Sciences Center
St. Louis,  Missouri,  63110-0250
United States
 

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

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

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

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

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

Swedish Cancer Institute
Seattle,  Washington,  98104
United States
 

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

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

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

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

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

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

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

CCOP - Greenville
Greenville,  South Carolina,  29615
United States
 

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

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

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

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

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

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

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

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

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

Boston Medical Center
Boston,  Massachusetts,  02118
United States
 

Arizona Cancer Center
Tucson,  Arizona,  85724
United States
 

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

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

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

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

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

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

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

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

Oregon Cancer Center
Portland,  Oregon,  97201-3098
United States
 

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

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

Eastern Virginia Medical School
Norfolk,  Virginia,  23507
United States
 

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

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

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

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

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

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

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

CCOP - Central Illinois
Decatur,  Illinois,  62526
United States
 

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

University of Colorado Cancer Center
Denver,  Colorado,  80010
United States
 

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

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

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

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

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

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

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

Stanford University
Stanford,  California,  94305
United States
 

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

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

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

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

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

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

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

Barbara Ann Karmanos Cancer Institute
Detroit,  Michigan,  48201-1379
United States
 

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

CCOP - Columbus
Columbus,  Ohio,  43206
United States
 

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

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

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

Cancer Center and Beckman Research Institute, City of Hope
Los Angeles,  California,  91010-3000
United States
 

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

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

CCOP - Dayton
Kettering,  Ohio,  45429
United States
 

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

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

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

MBCCOP - Gulf Coast
Mobile,  Alabama,  36688
United States
 

Loyola University Medical Center
Maywood,  Illinois,  60153
United States
 

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


Additional Information:
Study ID Numbers:
  CDR0000068318;  SWOG-S0004
Study Start Date: October 2000
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006487

Other Limited Stage Small Cell Lung Cancer Studies:
1. Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Small Cell Lung Cancer

2. Topotecan in Treating Patients With Relapsed Small Cell Lung Cancer

3. Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Limited-stage Small Cell Lung Cancer

4. Tirapazamine Combined With Chemotherapy and Radiation Therapy in Treating Patients With Limited-Stage Small Cell Lung Cancer

5. Neoadjuvant Chemoradiotherapy Followed By Surgery in Treating Patients With Limited-Stage Small Cell Lung Cancer

Related Studies:

Other limited stage small cell lung cancer Clinical Trials
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Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Limited-stage Small Cell Lung Cancer

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