- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT00006484
Combination Chemotherapy With or Without Tirapazamine in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer
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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Fase
- Fase 3
Contacten en locaties
Studie Locaties
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Alabama
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Mobile, Alabama, Verenigde Staten, 36688
- MBCCOP - Gulf Coast
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Arizona
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Phoenix, Arizona, Verenigde Staten, 85006-2726
- CCOP - Greater Phoenix
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Phoenix, Arizona, Verenigde Staten, 85012
- Veterans Affairs Medical Center - Phoenix (Hayden)
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Tucson, Arizona, Verenigde Staten, 85724
- Arizona Cancer Center
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Tucson, Arizona, Verenigde Staten, 85723
- Veterans Affairs Medical Center - Tucson
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Arkansas
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Little Rock, Arkansas, Verenigde Staten, 72205
- University of Arkansas for Medical Sciences
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Little Rock, Arkansas, Verenigde Staten, 72205
- Veterans Affairs Medical Center - Little Rock (McClellan)
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California
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Duarte, California, Verenigde Staten, 91010-3000
- Cancer Center and Beckman Research Institute, City of Hope
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Los Angeles, California, Verenigde Staten, 90095-1781
- Jonsson Comprehensive Cancer Center, UCLA
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Los Angeles, California, Verenigde Staten, 90033-0804
- USC/Norris Comprehensive Cancer Center and Hospital
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Martinez, California, Verenigde Staten, 94553
- Veterans Affairs Outpatient Clinic - Martinez
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Oakland, California, Verenigde Staten, 94609-3305
- CCOP - Bay Area Tumor Institute
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Orange, California, Verenigde Staten, 92868
- Chao Family Comprehensive Cancer Center
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Sacramento, California, Verenigde Staten, 95817
- University of California Davis Cancer Center
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San Francisco, California, Verenigde Staten, 94143-0128
- UCSF Cancer Center and Cancer Research Institute
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Santa Rosa, California, Verenigde Staten, 95403
- CCOP - Santa Rosa Memorial Hospital
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Travis Air Force Base, California, Verenigde Staten, 94535
- David Grant Medical Center
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Colorado
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Denver, Colorado, Verenigde Staten, 80220
- Veterans Affairs Medical Center - Denver
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Denver, Colorado, Verenigde Staten, 80010
- University of Colorado Cancer Center
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Georgia
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Atlanta, Georgia, Verenigde Staten, 30342-1701
- CCOP - Atlanta Regional
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Fort Gordon, Georgia, Verenigde Staten, 30905-5650
- Dwight David Eisenhower Army Medical Center
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Hawaii
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Honolulu, Hawaii, Verenigde Staten, 96813
- Cancer Research Center of Hawaii
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Illinois
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Chicago, Illinois, Verenigde Staten, 60612-7323
- MBCCOP - University of Illinois at Chicago
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Chicago, Illinois, Verenigde Staten, 60612
- Veterans Affairs Medical Center - Chicago (Westside Hospital)
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Decatur, Illinois, Verenigde Staten, 62526
- CCOP - Central Illinois
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Hines, Illinois, Verenigde Staten, 60141
- Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
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Maywood, Illinois, Verenigde Staten, 60153
- Loyola University Medical Center
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Iowa
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Bettendorf, Iowa, Verenigde Staten, 52722
- Hematology Oncology Associates of the Quad Cities
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Kansas
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Kansas City, Kansas, Verenigde Staten, 66160-7357
- University of Kansas Medical Center
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Wichita, Kansas, Verenigde Staten, 67214-3882
- CCOP - Wichita
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Wichita, Kansas, Verenigde Staten, 67218
- Veterans Affairs Medical Center - Wichita
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Kentucky
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Lexington, Kentucky, Verenigde Staten, 40511-1093
- Veterans Affairs Medical Center - Lexington
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Lexington, Kentucky, Verenigde Staten, 40536-0084
- Albert B. Chandler Medical Center, University of Kentucky
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Louisiana
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New Orleans, Louisiana, Verenigde Staten, 70112
- Tulane University School of Medicine
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New Orleans, Louisiana, Verenigde Staten, 70112
- MBCCOP - LSU Health Sciences Center
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Shreveport, Louisiana, Verenigde Staten, 71130-3932
- Louisiana State University Health Sciences Center - Shreveport
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Shreveport, Louisiana, Verenigde Staten, 71130
- Veterans Affairs Medical Center - Shreveport
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Massachusetts
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Boston, Massachusetts, Verenigde Staten, 02118
- Boston Medical Center
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Jamaica Plain, Massachusetts, Verenigde Staten, 02130
- Veterans Affairs Medical Center - Boston (Jamaica Plain)
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Michigan
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Ann Arbor, Michigan, Verenigde Staten, 48109-0752
- University of Michigan Comprehensive Cancer Center
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Ann Arbor, Michigan, Verenigde Staten, 48105
- Veterans Affairs Medical Center - Ann Arbor
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Ann Arbor, Michigan, Verenigde Staten, 48106
- CCOP - Ann Arbor Regional
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Detroit, Michigan, Verenigde Staten, 48202
- Henry Ford Hospital
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Detroit, Michigan, Verenigde Staten, 48201-1379
- Barbara Ann Karmanos Cancer Institute
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Detroit, Michigan, Verenigde Staten, 48201-1932
- Veterans Affairs Medical Center - Detroit
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Southfield, Michigan, Verenigde Staten, 48075-9975
- Providence Hospital - Southfield
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Minnesota
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Duluth, Minnesota, Verenigde Staten, 55805
- CCOP - Duluth
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Mississippi
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Biloxi, Mississippi, Verenigde Staten, 39531-2410
- Veterans Affairs Medical Center - Biloxi
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Jackson, Mississippi, Verenigde Staten, 39216-4505
- University of Mississippi Medical Center
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Jackson, Mississippi, Verenigde Staten, 39216
- Veterans Affairs Medical Center - Jackson
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Keesler AFB, Mississippi, Verenigde Staten, 39534-2576
- Keesler Medical Center - Keesler AFB
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Missouri
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Kansas City, Missouri, Verenigde Staten, 64128
- Veterans Affairs Medical Center - Kansas City
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Kansas City, Missouri, Verenigde Staten, 64131
- CCOP - Kansas City
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Saint Louis, Missouri, Verenigde Staten, 63110-0250
- St. Louis University Health Sciences Center
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Saint Louis, Missouri, Verenigde Staten, 63141
- CCOP - St. Louis-Cape Girardeau
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Springfield, Missouri, Verenigde Staten, 65807
- CCOP - Cancer Research for the Ozarks
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Montana
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Billings, Montana, Verenigde Staten, 59101
- CCOP - Montana Cancer Consortium
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New Mexico
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Albuquerque, New Mexico, Verenigde Staten, 87108-5138
- Veterans Affairs Medical Center - Albuquerque
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Albuquerque, New Mexico, Verenigde Staten, 87131
- MBCCOP - University of New Mexico HSC
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New York
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Albany, New York, Verenigde Staten, 12208
- Veterans Affairs Medical Center - Albany
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New York, New York, Verenigde Staten, 10032
- Herbert Irving Comprehensive Cancer Center
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Rochester, New York, Verenigde Staten, 14642
- University of Rochester Medical Center
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North Carolina
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Winston-Salem, North Carolina, Verenigde Staten, 27104-4241
- CCOP - Southeast Cancer Control Consortium
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Ohio
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Cincinnati, Ohio, Verenigde Staten, 45220-2288
- Veterans Affairs Medical Center - Cincinnati
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Cincinnati, Ohio, Verenigde Staten, 45267-0502
- Barrett Cancer Center, The University Hospital
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Cleveland, Ohio, Verenigde Staten, 44195
- Cleveland Clinic Taussig Cancer Center
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Columbus, Ohio, Verenigde Staten, 43206
- CCOP - Columbus
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Dayton, Ohio, Verenigde Staten, 45428
- Veterans Affairs Medical Center - Dayton
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Kettering, Ohio, Verenigde Staten, 45429
- CCOP - Dayton
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Toledo, Ohio, Verenigde Staten, 43623-3456
- CCOP - Toledo Community Hospital Oncology Program
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Oklahoma
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Oklahoma City, Oklahoma, Verenigde Staten, 73104
- Oklahoma Medical Research Foundation
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Oklahoma City, Oklahoma, Verenigde Staten, 73104
- Veterans Affairs Medical Center - Oklahoma City
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Oregon
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Portland, Oregon, Verenigde Staten, 97207
- Veterans Affairs Medical Center - Portland
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Portland, Oregon, Verenigde Staten, 97213
- CCOP - Columbia River Program
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Portland, Oregon, Verenigde Staten, 97201-3098
- Oregon Cancer Center
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South Carolina
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Charleston, South Carolina, Verenigde Staten, 29425-0721
- Medical University of South Carolina
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Charleston, South Carolina, Verenigde Staten, 29401-5799
- Veterans Affairs Medical Center - Charleston
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Greenville, South Carolina, Verenigde Staten, 29615
- CCOP - Greenville
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Spartanburg, South Carolina, Verenigde Staten, 29303
- CCOP - Upstate Carolina
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Texas
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Fort Sam Houston, Texas, Verenigde Staten, 78234
- Brooke Army Medical Center
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Galveston, Texas, Verenigde Staten, 77555-0209
- University of Texas Medical Branch
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Houston, Texas, Verenigde Staten, 77030
- Veterans Affairs Medical Center - Houston
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San Antonio, Texas, Verenigde Staten, 78284-7811
- University of Texas Health Science Center at San Antonio
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San Antonio, Texas, Verenigde Staten, 78284
- Veterans Affairs Medical Center - San Antonio (Murphy)
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Temple, Texas, Verenigde Staten, 76504
- Veterans Affairs Medical Center - Temple
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Temple, Texas, Verenigde Staten, 76508
- CCOP - Scott and White Hospital
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Utah
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Salt Lake City, Utah, Verenigde Staten, 84148
- Veterans Affairs Medical Center - Salt Lake City
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Salt Lake City, Utah, Verenigde Staten, 84112
- Huntsman Cancer Institute
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Washington
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Seattle, Washington, Verenigde Staten, 98101
- CCOP - Virginia Mason Research Center
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Seattle, Washington, Verenigde Staten, 98104
- Swedish Cancer Institute
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Seattle, Washington, Verenigde Staten, 98108
- Veterans Affairs Medical Center - Seattle
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Tacoma, Washington, Verenigde Staten, 98431-5000
- Madigan Army Medical Center
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Tacoma, Washington, Verenigde Staten, 98405-0986
- CCOP - Northwest
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Studie stoel: Stephen K. Williamson, MD, University of Kansas
Publicaties en nuttige links
Algemene publicaties
- 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.
Studie record data
Bestudeer belangrijke data
Studie start
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Ziekten van de luchtwegen
- Neoplasmata
- Longziekten
- Neoplasmata per site
- Neoplasmata van de luchtwegen
- Thoracale neoplasmata
- Carcinoom, bronchogeen
- Bronchiale neoplasmata
- Longneoplasmata
- Carcinoom, niet-kleincellige long
- Moleculaire mechanismen van farmacologische werking
- Antineoplastische middelen
- Tubuline-modulatoren
- Antimitotische middelen
- Mitose modulatoren
- Antineoplastische middelen, fytogeen
- Carboplatine
- Paclitaxel
- Tirapazamine
Andere studie-ID-nummers
- CDR0000068315
- SWOG-S0003
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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