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Home > "C" Clinical Trials Conditions > Combination Chemotherapy With or Without Tirapazamine in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer

Combination Chemotherapy With or Without Tirapazamine in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer



Combination Chemotherapy With or Without Tirapazamine in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer

For Condition: stage 4 non-small cell lung cancer,large cell lung cancer,recurrent non-small cell lung cancer,squamous cell lung cancer,stage 3B non-small cell lung cancer,adenocarcinoma of the lung
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. Combining more than one drug may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective for non-small cell lung cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of carboplatin plus paclitaxel with or without tirapazamine in treating patients who have stage IIIB or stage IV non-small cell lung cancer.
Details: OBJECTIVES: I. Compare the effects of paclitaxel and carboplatin with or without tirapazamine on progression-free survival and overall survival in patients with stage IV and selected stage IIIB non-small cell lung cancer. II. Compare response rates in patients treated with these regimens. III. Compare the toxic effects of these regimens in these patients. PROTOCOL OUTLINE: This is a randomized study. Patients are stratified according to weight loss (less than 5% vs 5% or more), stage of disease (IIIB vs IV), and lactate dehydrogenase level (normal vs abnormal). Patients are randomized to 1 of 2 treatment arms. Arm I: Patients receive tirapazamine IV over 2 hours followed by paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Arm II: Patients receive paclitaxel and carboplatin as in arm I. Treatment continues every 21 days for a total of 6 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for one year, and then every 6 months for 2 years, or until death. PROJECTED ACCRUAL: Approximately 500 patients (250 per arm) will be accrued for this study within 20 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 newly diagnosed advanced primary non-small cell lung cancer (NSCLC), including the following cellular types: - Adenocarcinoma - Large cell carcinoma - Squamous cell carcinoma - Unspecified carcinoma OR Recurrent disease after prior surgery and/or radiotherapy Stage IIIB disease - T4 lesion due to malignant pleural effusion OR Stage IV disease - Any T, any N, M1 (distant metastasis, including lesions in multiple lobes of the ipsilateral lung) Measurable or evaluable disease - Pleural effusions, ascites, and laboratory parameters not considered as only evidence of disease - Must be outside prior radiated field or area of prior surgical resection or new lesion must be present No known brain metastases --Prior/Concurrent Therapy-- Biologic therapy: No prior biologic therapy for NSCLC Chemotherapy: No prior systemic chemotherapy for NSCLC Endocrine therapy: Not specified Radiotherapy: - See Disease Characteristics - At least 3 weeks since prior radiotherapy and recovered - No concurrent radiotherapy 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 granulocyte count at least 1,500/mm3 - Platelet count at least 100,000/mm3 - Hemoglobin at least 9 g/dL Hepatic: - Bilirubin no greater than 2 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 - Creatinine clearance at least 50 mL/min Other: - Not pregnant or nursing - Fertile patients must use effective contraception - No peripheral neuropathy (motor or sensory) of grade 2 or greater - 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 stage I/II cancer in complete remission
Total Enrollment: 

Location and Contact Information:

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

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

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

CCOP - Columbus
Columbus,  Ohio,  43206
United States
 

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

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

University of Rochester Medical Center
Rochester,  New York,  14642
United States
 

Swedish Cancer Institute
Seattle,  Washington,  98104
United States
 

Medical University of South Carolina
Charleston,  South Carolina,  29425-0721
United States
 

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

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

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

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

UCSF Cancer Center and Cancer Research Institute
San Francisco,  California,  94143-0128
United States
 

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

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

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

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

CCOP - Central Illinois
Decatur,  Illinois,  62526
United States
 

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

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

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

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

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

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

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

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

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

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

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

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

CCOP - Dayton
Kettering,  Ohio,  45429
United States
 

Barrett Cancer Center, The University Hospital
Cincinnati,  Ohio,  45267-0502
United States
 

Arizona Cancer Center
Tucson,  Arizona,  85724
United States
 

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

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

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

Henry Ford Hospital
Detroit,  Michigan,  48202
United States
 

Veterans Affairs Medical Center - Charleston
Charleston,  South Carolina,  29401-5799
United States
 

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

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

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

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

CCOP - Ann Arbor Regional
Ann Arbor,  Michigan,  48106
United States
 

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

Boston Medical Center
Boston,  Massachusetts,  02118
United States
 

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

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

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

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

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

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

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

CCOP - Duluth
Duluth,  Minnesota,  55805
United States
 

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

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

MBCCOP - Gulf Coast
Mobile,  Alabama,  36688
United States
 

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

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

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

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

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

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

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

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

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

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

Veterans Affairs Medical Center - Houston
Houston,  Texas,  77030
United States
 

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

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

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

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

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

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

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

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

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

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

Veterans Affairs Medical Center - Albany
Albany,  New York,  12208
United States
 

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

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

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

CCOP - Toledo Community Hospital Oncology Program
Toledo,  Ohio,  43623-3456
United States
 

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

CCOP - Greenville
Greenville,  South Carolina,  29615
United States
 

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

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

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

Loyola University Medical Center
Maywood,  Illinois,  60153
United States
 

Madigan Army Medical Center
Tacoma,  Washington,  98431-5000
United States
 

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

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

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

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


Additional Information:
Study ID Numbers:
  CDR0000068315;  SWOG-S0003,CTSU
Study Start Date: November 2000
Record last reviewed: May 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006484

Other Large Cell Lung Cancer Studies:
1. Docetaxel With or Without Oblimersen in Treating Patients With Non-Small Cell Lung Cancer

2. Erlotinib in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer

3. Vinorelbine in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer

4. Vaccine Therapy and Sargramostim in Treating Patients With Non-small Cell Lung Cancer

5. 10-Propargyl-10-Deazaaminopterin in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer

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