- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Phase
- Phase 3
Contacts et emplacements
Lieux d'étude
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Alabama
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Mobile, Alabama, États-Unis, 36688
- MBCCOP - Gulf Coast
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Arizona
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Phoenix, Arizona, États-Unis, 85006-2726
- CCOP - Greater Phoenix
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Phoenix, Arizona, États-Unis, 85012
- Veterans Affairs Medical Center - Phoenix (Hayden)
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Tucson, Arizona, États-Unis, 85724
- Arizona Cancer Center
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Tucson, Arizona, États-Unis, 85723
- Veterans Affairs Medical Center - Tucson
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Arkansas
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Little Rock, Arkansas, États-Unis, 72205
- University of Arkansas for Medical Sciences
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Little Rock, Arkansas, États-Unis, 72205
- Veterans Affairs Medical Center - Little Rock (McClellan)
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California
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Duarte, California, États-Unis, 91010-3000
- Cancer Center and Beckman Research Institute, City of Hope
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Los Angeles, California, États-Unis, 90095-1781
- Jonsson Comprehensive Cancer Center, UCLA
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Los Angeles, California, États-Unis, 90033-0804
- USC/Norris Comprehensive Cancer Center and Hospital
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Martinez, California, États-Unis, 94553
- Veterans Affairs Outpatient Clinic - Martinez
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Oakland, California, États-Unis, 94609-3305
- CCOP - Bay Area Tumor Institute
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Orange, California, États-Unis, 92868
- Chao Family Comprehensive Cancer Center
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Sacramento, California, États-Unis, 95817
- University of California Davis Cancer Center
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San Francisco, California, États-Unis, 94143-0128
- UCSF Cancer Center and Cancer Research Institute
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Santa Rosa, California, États-Unis, 95403
- CCOP - Santa Rosa Memorial Hospital
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Travis Air Force Base, California, États-Unis, 94535
- David Grant Medical Center
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Colorado
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Denver, Colorado, États-Unis, 80220
- Veterans Affairs Medical Center - Denver
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Denver, Colorado, États-Unis, 80010
- University of Colorado Cancer Center
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Georgia
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Atlanta, Georgia, États-Unis, 30342-1701
- CCOP - Atlanta Regional
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Fort Gordon, Georgia, États-Unis, 30905-5650
- Dwight David Eisenhower Army Medical Center
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Hawaii
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Honolulu, Hawaii, États-Unis, 96813
- Cancer Research Center of Hawaii
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Illinois
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Chicago, Illinois, États-Unis, 60612-7323
- MBCCOP - University of Illinois at Chicago
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Chicago, Illinois, États-Unis, 60612
- Veterans Affairs Medical Center - Chicago (Westside Hospital)
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Decatur, Illinois, États-Unis, 62526
- CCOP - Central Illinois
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Hines, Illinois, États-Unis, 60141
- Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
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Maywood, Illinois, États-Unis, 60153
- Loyola University Medical Center
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Iowa
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Bettendorf, Iowa, États-Unis, 52722
- Hematology Oncology Associates of the Quad Cities
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Kansas
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Kansas City, Kansas, États-Unis, 66160-7357
- University Of Kansas Medical Center
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Wichita, Kansas, États-Unis, 67214-3882
- CCOP - Wichita
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Wichita, Kansas, États-Unis, 67218
- Veterans Affairs Medical Center - Wichita
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Kentucky
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Lexington, Kentucky, États-Unis, 40511-1093
- Veterans Affairs Medical Center - Lexington
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Lexington, Kentucky, États-Unis, 40536-0084
- Albert B. Chandler Medical Center, University of Kentucky
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Louisiana
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New Orleans, Louisiana, États-Unis, 70112
- Tulane University School of Medicine
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New Orleans, Louisiana, États-Unis, 70112
- MBCCOP - LSU Health Sciences Center
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Shreveport, Louisiana, États-Unis, 71130-3932
- Louisiana State University Health Sciences Center - Shreveport
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Shreveport, Louisiana, États-Unis, 71130
- Veterans Affairs Medical Center - Shreveport
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Massachusetts
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Boston, Massachusetts, États-Unis, 02118
- Boston Medical Center
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Jamaica Plain, Massachusetts, États-Unis, 02130
- Veterans Affairs Medical Center - Boston (Jamaica Plain)
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Michigan
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Ann Arbor, Michigan, États-Unis, 48109-0752
- University of Michigan Comprehensive Cancer Center
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Ann Arbor, Michigan, États-Unis, 48105
- Veterans Affairs Medical Center - Ann Arbor
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Ann Arbor, Michigan, États-Unis, 48106
- CCOP - Ann Arbor Regional
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Detroit, Michigan, États-Unis, 48202
- Henry Ford Hospital
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Detroit, Michigan, États-Unis, 48201-1379
- Barbara Ann Karmanos Cancer Institute
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Detroit, Michigan, États-Unis, 48201-1932
- Veterans Affairs Medical Center - Detroit
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Southfield, Michigan, États-Unis, 48075-9975
- Providence Hospital - Southfield
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Minnesota
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Duluth, Minnesota, États-Unis, 55805
- CCOP - Duluth
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Mississippi
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Biloxi, Mississippi, États-Unis, 39531-2410
- Veterans Affairs Medical Center - Biloxi
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Jackson, Mississippi, États-Unis, 39216-4505
- University of Mississippi Medical Center
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Jackson, Mississippi, États-Unis, 39216
- Veterans Affairs Medical Center - Jackson
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Keesler AFB, Mississippi, États-Unis, 39534-2576
- Keesler Medical Center - Keesler AFB
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Missouri
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Kansas City, Missouri, États-Unis, 64128
- Veterans Affairs Medical Center - Kansas City
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Kansas City, Missouri, États-Unis, 64131
- CCOP - Kansas City
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Saint Louis, Missouri, États-Unis, 63110-0250
- St. Louis University Health Sciences Center
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Saint Louis, Missouri, États-Unis, 63141
- CCOP - St. Louis-Cape Girardeau
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Springfield, Missouri, États-Unis, 65807
- CCOP - Cancer Research for the Ozarks
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Montana
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Billings, Montana, États-Unis, 59101
- CCOP - Montana Cancer Consortium
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New Mexico
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Albuquerque, New Mexico, États-Unis, 87108-5138
- Veterans Affairs Medical Center - Albuquerque
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Albuquerque, New Mexico, États-Unis, 87131
- MBCCOP - University of New Mexico HSC
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New York
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Albany, New York, États-Unis, 12208
- Veterans Affairs Medical Center - Albany
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New York, New York, États-Unis, 10032
- Herbert Irving Comprehensive Cancer Center
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Rochester, New York, États-Unis, 14642
- University of Rochester Medical Center
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North Carolina
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Winston-Salem, North Carolina, États-Unis, 27104-4241
- CCOP - Southeast Cancer Control Consortium
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Ohio
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Cincinnati, Ohio, États-Unis, 45220-2288
- Veterans Affairs Medical Center - Cincinnati
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Cincinnati, Ohio, États-Unis, 45267-0502
- Barrett Cancer Center, The University Hospital
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Cleveland, Ohio, États-Unis, 44195
- Cleveland Clinic Taussig Cancer Center
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Columbus, Ohio, États-Unis, 43206
- CCOP - Columbus
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Dayton, Ohio, États-Unis, 45428
- Veterans Affairs Medical Center - Dayton
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Kettering, Ohio, États-Unis, 45429
- CCOP - Dayton
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Toledo, Ohio, États-Unis, 43623-3456
- CCOP - Toledo Community Hospital Oncology Program
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Oklahoma
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Oklahoma City, Oklahoma, États-Unis, 73104
- Oklahoma Medical Research Foundation
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Oklahoma City, Oklahoma, États-Unis, 73104
- Veterans Affairs Medical Center - Oklahoma City
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Oregon
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Portland, Oregon, États-Unis, 97207
- Veterans Affairs Medical Center - Portland
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Portland, Oregon, États-Unis, 97213
- CCOP - Columbia River Program
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Portland, Oregon, États-Unis, 97201-3098
- Oregon Cancer Center
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South Carolina
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Charleston, South Carolina, États-Unis, 29425-0721
- Medical University of South Carolina
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Charleston, South Carolina, États-Unis, 29401-5799
- Veterans Affairs Medical Center - Charleston
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Greenville, South Carolina, États-Unis, 29615
- CCOP - Greenville
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Spartanburg, South Carolina, États-Unis, 29303
- CCOP - Upstate Carolina
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Texas
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Fort Sam Houston, Texas, États-Unis, 78234
- Brooke Army Medical Center
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Galveston, Texas, États-Unis, 77555-0209
- University of Texas Medical Branch
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Houston, Texas, États-Unis, 77030
- Veterans Affairs Medical Center - Houston
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San Antonio, Texas, États-Unis, 78284-7811
- University of Texas Health Science Center at San Antonio
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San Antonio, Texas, États-Unis, 78284
- Veterans Affairs Medical Center - San Antonio (Murphy)
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Temple, Texas, États-Unis, 76504
- Veterans Affairs Medical Center - Temple
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Temple, Texas, États-Unis, 76508
- CCOP - Scott and White Hospital
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Utah
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Salt Lake City, Utah, États-Unis, 84148
- Veterans Affairs Medical Center - Salt Lake City
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Salt Lake City, Utah, États-Unis, 84112
- Huntsman Cancer Institute
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Washington
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Seattle, Washington, États-Unis, 98101
- CCOP - Virginia Mason Research Center
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Seattle, Washington, États-Unis, 98104
- Swedish Cancer Institute
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Seattle, Washington, États-Unis, 98108
- Veterans Affairs Medical Center - Seattle
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Tacoma, Washington, États-Unis, 98431-5000
- Madigan Army Medical Center
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Tacoma, Washington, États-Unis, 98405-0986
- CCOP - Northwest
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chaise d'étude: Stephen K. Williamson, MD, University of Kansas
Publications et liens utiles
Publications générales
- 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.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Maladies des voies respiratoires
- Tumeurs
- Maladies pulmonaires
- Tumeurs par site
- Tumeurs des voies respiratoires
- Tumeurs thoraciques
- Carcinome bronchique
- Tumeurs bronchiques
- Tumeurs pulmonaires
- Carcinome pulmonaire non à petites cellules
- Mécanismes moléculaires de l'action pharmacologique
- Agents antinéoplasiques
- Modulateurs de tubuline
- Agents antimitotiques
- Modulateurs de mitose
- Agents antinéoplasiques phytogéniques
- Carboplatine
- Paclitaxel
- Tirapazamine
Autres numéros d'identification d'étude
- CDR0000068315
- SWOG-S0003
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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