Combination Chemotherapy With or Without Tirapazamine in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer
20. juni 2013 opdateret af: Southwest Oncology Group
Randomized Phase III Trial Of Carboplatin And Paclitaxel Plus Tirapazamine Versus Carboplatin And Paclitaxel In Patients With Advanced Non-Small Cell Lung Cancer
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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
OBJECTIVES:
- 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.
- Compare response rates in patients treated with these regimens.
- Compare the toxic effects of these regimens in these patients.
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.
Undersøgelsestype
Interventionel
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Alabama
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Mobile, Alabama, Forenede Stater, 36688
- MBCCOP - Gulf Coast
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Arizona
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Phoenix, Arizona, Forenede Stater, 85006-2726
- CCOP - Greater Phoenix
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Phoenix, Arizona, Forenede Stater, 85012
- Veterans Affairs Medical Center - Phoenix (Hayden)
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Tucson, Arizona, Forenede Stater, 85724
- Arizona Cancer Center
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Tucson, Arizona, Forenede Stater, 85723
- Veterans Affairs Medical Center - Tucson
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Arkansas
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Little Rock, Arkansas, Forenede Stater, 72205
- University of Arkansas for Medical Sciences
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Little Rock, Arkansas, Forenede Stater, 72205
- Veterans Affairs Medical Center - Little Rock (McClellan)
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California
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Duarte, California, Forenede Stater, 91010-3000
- Cancer Center and Beckman Research Institute, City of Hope
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Los Angeles, California, Forenede Stater, 90095-1781
- Jonsson Comprehensive Cancer Center, UCLA
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Los Angeles, California, Forenede Stater, 90033-0804
- USC/Norris Comprehensive Cancer Center and Hospital
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Martinez, California, Forenede Stater, 94553
- Veterans Affairs Outpatient Clinic - Martinez
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Oakland, California, Forenede Stater, 94609-3305
- CCOP - Bay Area Tumor Institute
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Orange, California, Forenede Stater, 92868
- Chao Family Comprehensive Cancer Center
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Sacramento, California, Forenede Stater, 95817
- University of California Davis Cancer Center
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San Francisco, California, Forenede Stater, 94143-0128
- UCSF Cancer Center and Cancer Research Institute
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Santa Rosa, California, Forenede Stater, 95403
- CCOP - Santa Rosa Memorial Hospital
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Travis Air Force Base, California, Forenede Stater, 94535
- David Grant Medical Center
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Colorado
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Denver, Colorado, Forenede Stater, 80220
- Veterans Affairs Medical Center - Denver
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Denver, Colorado, Forenede Stater, 80010
- University of Colorado Cancer Center
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Georgia
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Atlanta, Georgia, Forenede Stater, 30342-1701
- CCOP - Atlanta Regional
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Fort Gordon, Georgia, Forenede Stater, 30905-5650
- Dwight David Eisenhower Army Medical Center
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Hawaii
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Honolulu, Hawaii, Forenede Stater, 96813
- Cancer Research Center of Hawaii
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Illinois
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Chicago, Illinois, Forenede Stater, 60612-7323
- MBCCOP - University of Illinois at Chicago
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Chicago, Illinois, Forenede Stater, 60612
- Veterans Affairs Medical Center - Chicago (Westside Hospital)
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Decatur, Illinois, Forenede Stater, 62526
- CCOP - Central Illinois
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Hines, Illinois, Forenede Stater, 60141
- Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
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Maywood, Illinois, Forenede Stater, 60153
- Loyola University Medical Center
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Iowa
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Bettendorf, Iowa, Forenede Stater, 52722
- Hematology Oncology Associates of the Quad Cities
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Kansas
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Kansas City, Kansas, Forenede Stater, 66160-7357
- University of Kansas Medical Center
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Wichita, Kansas, Forenede Stater, 67214-3882
- CCOP - Wichita
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Wichita, Kansas, Forenede Stater, 67218
- Veterans Affairs Medical Center - Wichita
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Kentucky
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Lexington, Kentucky, Forenede Stater, 40511-1093
- Veterans Affairs Medical Center - Lexington
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Lexington, Kentucky, Forenede Stater, 40536-0084
- Albert B. Chandler Medical Center, University of Kentucky
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Louisiana
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New Orleans, Louisiana, Forenede Stater, 70112
- Tulane University School of Medicine
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New Orleans, Louisiana, Forenede Stater, 70112
- MBCCOP - LSU Health Sciences Center
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Shreveport, Louisiana, Forenede Stater, 71130-3932
- Louisiana State University Health Sciences Center - Shreveport
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Shreveport, Louisiana, Forenede Stater, 71130
- Veterans Affairs Medical Center - Shreveport
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02118
- Boston Medical Center
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Jamaica Plain, Massachusetts, Forenede Stater, 02130
- Veterans Affairs Medical Center - Boston (Jamaica Plain)
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Michigan
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Ann Arbor, Michigan, Forenede Stater, 48109-0752
- University of Michigan Comprehensive Cancer Center
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Ann Arbor, Michigan, Forenede Stater, 48105
- Veterans Affairs Medical Center - Ann Arbor
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Ann Arbor, Michigan, Forenede Stater, 48106
- CCOP - Ann Arbor Regional
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Detroit, Michigan, Forenede Stater, 48202
- Henry Ford Hospital
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Detroit, Michigan, Forenede Stater, 48201-1379
- Barbara Ann Karmanos Cancer Institute
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Detroit, Michigan, Forenede Stater, 48201-1932
- Veterans Affairs Medical Center - Detroit
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Southfield, Michigan, Forenede Stater, 48075-9975
- Providence Hospital - Southfield
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Minnesota
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Duluth, Minnesota, Forenede Stater, 55805
- CCOP - Duluth
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Mississippi
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Biloxi, Mississippi, Forenede Stater, 39531-2410
- Veterans Affairs Medical Center - Biloxi
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Jackson, Mississippi, Forenede Stater, 39216-4505
- University of Mississippi Medical Center
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Jackson, Mississippi, Forenede Stater, 39216
- Veterans Affairs Medical Center - Jackson
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Keesler AFB, Mississippi, Forenede Stater, 39534-2576
- Keesler Medical Center - Keesler AFB
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Missouri
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Kansas City, Missouri, Forenede Stater, 64128
- Veterans Affairs Medical Center - Kansas City
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Kansas City, Missouri, Forenede Stater, 64131
- CCOP - Kansas City
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Saint Louis, Missouri, Forenede Stater, 63110-0250
- St. Louis University Health Sciences Center
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Saint Louis, Missouri, Forenede Stater, 63141
- CCOP - St. Louis-Cape Girardeau
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Springfield, Missouri, Forenede Stater, 65807
- CCOP - Cancer Research for the Ozarks
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Montana
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Billings, Montana, Forenede Stater, 59101
- CCOP - Montana Cancer Consortium
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New Mexico
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Albuquerque, New Mexico, Forenede Stater, 87108-5138
- Veterans Affairs Medical Center - Albuquerque
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Albuquerque, New Mexico, Forenede Stater, 87131
- MBCCOP - University of New Mexico HSC
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New York
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Albany, New York, Forenede Stater, 12208
- Veterans Affairs Medical Center - Albany
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New York, New York, Forenede Stater, 10032
- Herbert Irving Comprehensive Cancer Center
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Rochester, New York, Forenede Stater, 14642
- University of Rochester Medical Center
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North Carolina
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Winston-Salem, North Carolina, Forenede Stater, 27104-4241
- CCOP - Southeast Cancer Control Consortium
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Ohio
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Cincinnati, Ohio, Forenede Stater, 45220-2288
- Veterans Affairs Medical Center - Cincinnati
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Cincinnati, Ohio, Forenede Stater, 45267-0502
- Barrett Cancer Center, The University Hospital
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Cleveland, Ohio, Forenede Stater, 44195
- Cleveland Clinic Taussig Cancer Center
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Columbus, Ohio, Forenede Stater, 43206
- CCOP - Columbus
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Dayton, Ohio, Forenede Stater, 45428
- Veterans Affairs Medical Center - Dayton
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Kettering, Ohio, Forenede Stater, 45429
- CCOP - Dayton
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Toledo, Ohio, Forenede Stater, 43623-3456
- CCOP - Toledo Community Hospital Oncology Program
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Oklahoma
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Oklahoma City, Oklahoma, Forenede Stater, 73104
- Oklahoma Medical Research Foundation
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Oklahoma City, Oklahoma, Forenede Stater, 73104
- Veterans Affairs Medical Center - Oklahoma City
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Oregon
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Portland, Oregon, Forenede Stater, 97207
- Veterans Affairs Medical Center - Portland
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Portland, Oregon, Forenede Stater, 97213
- CCOP - Columbia River Program
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Portland, Oregon, Forenede Stater, 97201-3098
- Oregon Cancer Center
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South Carolina
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Charleston, South Carolina, Forenede Stater, 29425-0721
- Medical University of South Carolina
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Charleston, South Carolina, Forenede Stater, 29401-5799
- Veterans Affairs Medical Center - Charleston
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Greenville, South Carolina, Forenede Stater, 29615
- CCOP - Greenville
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Spartanburg, South Carolina, Forenede Stater, 29303
- CCOP - Upstate Carolina
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Texas
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Fort Sam Houston, Texas, Forenede Stater, 78234
- Brooke Army Medical Center
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Galveston, Texas, Forenede Stater, 77555-0209
- University of Texas Medical Branch
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Houston, Texas, Forenede Stater, 77030
- Veterans Affairs Medical Center - Houston
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San Antonio, Texas, Forenede Stater, 78284-7811
- University of Texas Health Science Center at San Antonio
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San Antonio, Texas, Forenede Stater, 78284
- Veterans Affairs Medical Center - San Antonio (Murphy)
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Temple, Texas, Forenede Stater, 76504
- Veterans Affairs Medical Center - Temple
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Temple, Texas, Forenede Stater, 76508
- CCOP - Scott and White Hospital
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Utah
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Salt Lake City, Utah, Forenede Stater, 84148
- Veterans Affairs Medical Center - Salt Lake City
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Salt Lake City, Utah, Forenede Stater, 84112
- Huntsman Cancer Institute
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Washington
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Seattle, Washington, Forenede Stater, 98101
- CCOP - Virginia Mason Research Center
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Seattle, Washington, Forenede Stater, 98104
- Swedish Cancer Institute
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Seattle, Washington, Forenede Stater, 98108
- Veterans Affairs Medical Center - Seattle
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Tacoma, Washington, Forenede Stater, 98431-5000
- Madigan Army Medical Center
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Tacoma, Washington, Forenede Stater, 98405-0986
- CCOP - Northwest
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- Zubrod 0-1
Life expectancy:
- Not specified
Hematopoietic:
- Absolute granulocyte count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
- 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
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Studiestol: Stephen K. Williamson, MD, University of Kansas
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Lara PN Jr, Redman MW, Kelly K, Edelman MJ, Williamson SK, Crowley JJ, Gandara DR; Southwest Oncology Group. Disease control rate at 8 weeks predicts clinical benefit in advanced non-small-cell lung cancer: results from Southwest Oncology Group randomized trials. J Clin Oncol. 2008 Jan 20;26(3):463-7. doi: 10.1200/JCO.2007.13.0344.
- Lara PN Jr, Redman MW, Kelly K, et al.: Alternative measures predicting clinical benefit in advanced non-small cell lung cancer (NSCLC) from Southwest Oncology Group (SWOG) randomized trials: implications for clinical trial design. [Abstract] J Clin Oncol 24 (Suppl 18): A-7006, 365s, 2006.
- Gandara DR, Kawaguchi T, Crowley J, Moon J, Furuse K, Kawahara M, Teramukai S, Ohe Y, Kubota K, Williamson SK, Gautschi O, Lenz HJ, McLeod HL, Lara PN Jr, Coltman CA Jr, Fukuoka M, Saijo N, Fukushima M, Mack PC. Japanese-US common-arm analysis of paclitaxel plus carboplatin in advanced non-small-cell lung cancer: a model for assessing population-related pharmacogenomics. J Clin Oncol. 2009 Jul 20;27(21):3540-6. doi: 10.1200/JCO.2008.20.8793. Epub 2009 May 26.
- Mack PC, Redman MW, Chansky K, Williamson SK, Farneth NC, Lara PN Jr, Franklin WA, Le QT, Crowley JJ, Gandara DR; SWOG. Lower osteopontin plasma levels are associated with superior outcomes in advanced non-small-cell lung cancer patients receiving platinum-based chemotherapy: SWOG Study S0003. J Clin Oncol. 2008 Oct 10;26(29):4771-6. doi: 10.1200/JCO.2008.17.0662. Epub 2008 Sep 8.
- Mack PC, Redman MW, Chansky K, et al.: Elevated osteopontin (OPN) plasma levels are highly prognostic in advanced non-small cell lung cancer (NSCLC): analysis of SWOG S0003. [Abstract] J Clin Oncol 24 (Suppl 18): A-7198, 413s, 2006.
- Williamson SK, Crowley JJ, Lara PN Jr, McCoy J, Lau DH, Tucker RW, Mills GM, Gandara DR; Southwest Oncology Group Trial S0003. Phase III trial of paclitaxel plus carboplatin with or without tirapazamine in advanced non-small-cell lung cancer: Southwest Oncology Group Trial S0003. J Clin Oncol. 2005 Dec 20;23(36):9097-104. doi: 10.1200/JCO.2005.01.3771.
- Kimura T, Holland WS, Kawaguchi T, Williamson SK, Chansky K, Crowley JJ, Doroshow JH, Lenz HJ, Gandara DR, Gumerlock PH. Mutant DNA in plasma of lung cancer patients: potential for monitoring response to therapy. Ann N Y Acad Sci. 2004 Jun;1022:55-60. doi: 10.1196/annals.1318.010.
- Williamson SK, Crowley JJ, Lara PN, et al.: S0003: paclitaxel/carboplatin (PC) versus PC + tirapazamine (PCT) in advanced non-small cell lung cancer (NSCLC). A phase III Southwest Oncology Group (SWOG) trial. [Abstract] Lung Cancer 41 (Suppl 2): A-O-89, S29, 2003.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. november 2000
Studieafslutning (Faktiske)
1. april 2006
Datoer for studieregistrering
Først indsendt
6. november 2000
Først indsendt, der opfyldte QC-kriterier
30. maj 2003
Først opslået (Skøn)
2. juni 2003
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
24. juni 2013
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
20. juni 2013
Sidst verificeret
1. januar 2002
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Luftvejssygdomme
- Neoplasmer
- Lungesygdomme
- Neoplasmer efter sted
- Neoplasmer i luftvejene
- Thoracale neoplasmer
- Karcinom, bronkogent
- Bronkiale neoplasmer
- Lungeneoplasmer
- Karcinom, ikke-småcellet lunge
- Molekylære mekanismer for farmakologisk virkning
- Antineoplastiske midler
- Tubulin modulatorer
- Antimitotiske midler
- Mitose modulatorer
- Antineoplastiske midler, fytogene
- Carboplatin
- Paclitaxel
- Tirapazamin
Andre undersøgelses-id-numre
- CDR0000068315
- SWOG-S0003
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Lungekræft
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Seoul National University HospitalAfsluttet
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Seoul National University HospitalAfsluttet
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Chinese Chronic Respiratory Disease Research NetworkRekruttering
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Mansoura UniversityAfsluttetOne Lung VentilationEgypten
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Dokuz Eylul UniversityAfsluttetOne Lung VentilationKalkun
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Yonsei UniversityAfsluttetOne Lung VentilationKorea, Republikken
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Kliniske forsøg med carboplatin
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Eisai Inc.AfsluttetKræftForenede Stater, Østrig, Indien
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Shanghai Pulmonary Hospital, Shanghai, ChinaIkke rekrutterer endnu
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Zhejiang Cancer HospitalRekrutteringLivmoderhalskræft | HER2Kina
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Samyang Biopharmaceuticals CorporationAfsluttet
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Tang-Du HospitalRekrutteringHoved- og nakkekræftKina
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NHS Greater Glasgow and ClydeAfsluttetLivmoderhalskræft | Æggelederkræft | Primær peritoneal kræftDet Forenede Kongerige, Australien, New Zealand
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Duke UniversityAfsluttetTumorer i hjernen og centralnervesystemetForenede Stater, Canada
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Sun Yat-sen UniversityIkke rekrutterer endnu
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National Cancer Institute (NCI)AfsluttetBrystkræft | LivmoderhalskræftForenede Stater
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Medical Research CouncilEuropean Organisation for Research and Treatment of Cancer - EORTCAfsluttetTestikulær kimcelletumorDet Forenede Kongerige, Canada, Norge, Holland, Sydafrika, Brasilien, Finland