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

2013년 6월 20일 업데이트: 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.

연구 개요

상태

완전한

정황

폐암

개입 / 치료

상세 설명

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.

연구 유형

중재적

단계

3단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

미국
- Alabama
  - Mobile, Alabama, 미국, 36688
    - MBCCOP - Gulf Coast
- Arizona
  - Phoenix, Arizona, 미국, 85006-2726
    - CCOP - Greater Phoenix
  - Phoenix, Arizona, 미국, 85012
    - Veterans Affairs Medical Center - Phoenix (Hayden)
  - Tucson, Arizona, 미국, 85724
    - Arizona Cancer Center
  - Tucson, Arizona, 미국, 85723
    - Veterans Affairs Medical Center - Tucson
- Arkansas
  - Little Rock, Arkansas, 미국, 72205
    - University of Arkansas for Medical Sciences
  - Little Rock, Arkansas, 미국, 72205
    - Veterans Affairs Medical Center - Little Rock (McClellan)
- California
  - Duarte, California, 미국, 91010-3000
    - Cancer Center and Beckman Research Institute, City of Hope
  - Los Angeles, California, 미국, 90095-1781
    - Jonsson Comprehensive Cancer Center, UCLA
  - Los Angeles, California, 미국, 90033-0804
    - USC/Norris Comprehensive Cancer Center and Hospital
  - Martinez, California, 미국, 94553
    - Veterans Affairs Outpatient Clinic - Martinez
  - Oakland, California, 미국, 94609-3305
    - CCOP - Bay Area Tumor Institute
  - Orange, California, 미국, 92868
    - Chao Family Comprehensive Cancer Center
  - Sacramento, California, 미국, 95817
    - University of California Davis Cancer Center
  - San Francisco, California, 미국, 94143-0128
    - UCSF Cancer Center and Cancer Research Institute
  - Santa Rosa, California, 미국, 95403
    - CCOP - Santa Rosa Memorial Hospital
  - Travis Air Force Base, California, 미국, 94535
    - David Grant Medical Center
- Colorado
  - Denver, Colorado, 미국, 80220
    - Veterans Affairs Medical Center - Denver
  - Denver, Colorado, 미국, 80010
    - University of Colorado Cancer Center
- Georgia
  - Atlanta, Georgia, 미국, 30342-1701
    - CCOP - Atlanta Regional
  - Fort Gordon, Georgia, 미국, 30905-5650
    - Dwight David Eisenhower Army Medical Center
- Hawaii
  - Honolulu, Hawaii, 미국, 96813
    - Cancer Research Center of Hawaii
- Illinois
  - Chicago, Illinois, 미국, 60612-7323
    - MBCCOP - University of Illinois at Chicago
  - Chicago, Illinois, 미국, 60612
    - Veterans Affairs Medical Center - Chicago (Westside Hospital)
  - Decatur, Illinois, 미국, 62526
    - CCOP - Central Illinois
  - Hines, Illinois, 미국, 60141
    - Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
  - Maywood, Illinois, 미국, 60153
    - Loyola University Medical Center
- Iowa
  - Bettendorf, Iowa, 미국, 52722
    - Hematology Oncology Associates of the Quad Cities
- Kansas
  - Kansas City, Kansas, 미국, 66160-7357
    - University of Kansas Medical Center
  - Wichita, Kansas, 미국, 67214-3882
    - CCOP - Wichita
  - Wichita, Kansas, 미국, 67218
    - Veterans Affairs Medical Center - Wichita
- Kentucky
  - Lexington, Kentucky, 미국, 40511-1093
    - Veterans Affairs Medical Center - Lexington
  - Lexington, Kentucky, 미국, 40536-0084
    - Albert B. Chandler Medical Center, University of Kentucky
- Louisiana
  - New Orleans, Louisiana, 미국, 70112
    - Tulane University School of Medicine
  - New Orleans, Louisiana, 미국, 70112
    - MBCCOP - LSU Health Sciences Center
  - Shreveport, Louisiana, 미국, 71130-3932
    - Louisiana State University Health Sciences Center - Shreveport
  - Shreveport, Louisiana, 미국, 71130
    - Veterans Affairs Medical Center - Shreveport
- Massachusetts
  - Boston, Massachusetts, 미국, 02118
    - Boston Medical Center
  - Jamaica Plain, Massachusetts, 미국, 02130
    - Veterans Affairs Medical Center - Boston (Jamaica Plain)
- Michigan
  - Ann Arbor, Michigan, 미국, 48109-0752
    - University of Michigan Comprehensive Cancer Center
  - Ann Arbor, Michigan, 미국, 48105
    - Veterans Affairs Medical Center - Ann Arbor
  - Ann Arbor, Michigan, 미국, 48106
    - CCOP - Ann Arbor Regional
  - Detroit, Michigan, 미국, 48202
    - Henry Ford Hospital
  - Detroit, Michigan, 미국, 48201-1379
    - Barbara Ann Karmanos Cancer Institute
  - Detroit, Michigan, 미국, 48201-1932
    - Veterans Affairs Medical Center - Detroit
  - Southfield, Michigan, 미국, 48075-9975
    - Providence Hospital - Southfield
- Minnesota
  - Duluth, Minnesota, 미국, 55805
    - CCOP - Duluth
- Mississippi
  - Biloxi, Mississippi, 미국, 39531-2410
    - Veterans Affairs Medical Center - Biloxi
  - Jackson, Mississippi, 미국, 39216-4505
    - University of Mississippi Medical Center
  - Jackson, Mississippi, 미국, 39216
    - Veterans Affairs Medical Center - Jackson
  - Keesler AFB, Mississippi, 미국, 39534-2576
    - Keesler Medical Center - Keesler AFB
- Missouri
  - Kansas City, Missouri, 미국, 64128
    - Veterans Affairs Medical Center - Kansas City
  - Kansas City, Missouri, 미국, 64131
    - CCOP - Kansas City
  - Saint Louis, Missouri, 미국, 63110-0250
    - St. Louis University Health Sciences Center
  - Saint Louis, Missouri, 미국, 63141
    - CCOP - St. Louis-Cape Girardeau
  - Springfield, Missouri, 미국, 65807
    - CCOP - Cancer Research for the Ozarks
- Montana
  - Billings, Montana, 미국, 59101
    - CCOP - Montana Cancer Consortium
- New Mexico
  - Albuquerque, New Mexico, 미국, 87108-5138
    - Veterans Affairs Medical Center - Albuquerque
  - Albuquerque, New Mexico, 미국, 87131
    - MBCCOP - University of New Mexico HSC
- New York
  - Albany, New York, 미국, 12208
    - Veterans Affairs Medical Center - Albany
  - New York, New York, 미국, 10032
    - Herbert Irving Comprehensive Cancer Center
  - Rochester, New York, 미국, 14642
    - University of Rochester Medical Center
- North Carolina
  - Winston-Salem, North Carolina, 미국, 27104-4241
    - CCOP - Southeast Cancer Control Consortium
- Ohio
  - Cincinnati, Ohio, 미국, 45220-2288
    - Veterans Affairs Medical Center - Cincinnati
  - Cincinnati, Ohio, 미국, 45267-0502
    - Barrett Cancer Center, The University Hospital
  - Cleveland, Ohio, 미국, 44195
    - Cleveland Clinic Taussig Cancer Center
  - Columbus, Ohio, 미국, 43206
    - CCOP - Columbus
  - Dayton, Ohio, 미국, 45428
    - Veterans Affairs Medical Center - Dayton
  - Kettering, Ohio, 미국, 45429
    - CCOP - Dayton
  - Toledo, Ohio, 미국, 43623-3456
    - CCOP - Toledo Community Hospital Oncology Program
- Oklahoma
  - Oklahoma City, Oklahoma, 미국, 73104
    - Oklahoma Medical Research Foundation
  - Oklahoma City, Oklahoma, 미국, 73104
    - Veterans Affairs Medical Center - Oklahoma City
- Oregon
  - Portland, Oregon, 미국, 97207
    - Veterans Affairs Medical Center - Portland
  - Portland, Oregon, 미국, 97213
    - CCOP - Columbia River Program
  - Portland, Oregon, 미국, 97201-3098
    - Oregon Cancer Center
- South Carolina
  - Charleston, South Carolina, 미국, 29425-0721
    - Medical University of South Carolina
  - Charleston, South Carolina, 미국, 29401-5799
    - Veterans Affairs Medical Center - Charleston
  - Greenville, South Carolina, 미국, 29615
    - CCOP - Greenville
  - Spartanburg, South Carolina, 미국, 29303
    - CCOP - Upstate Carolina
- Texas
  - Fort Sam Houston, Texas, 미국, 78234
    - Brooke Army Medical Center
  - Galveston, Texas, 미국, 77555-0209
    - University of Texas Medical Branch
  - Houston, Texas, 미국, 77030
    - Veterans Affairs Medical Center - Houston
  - San Antonio, Texas, 미국, 78284-7811
    - University of Texas Health Science Center at San Antonio
  - San Antonio, Texas, 미국, 78284
    - Veterans Affairs Medical Center - San Antonio (Murphy)
  - Temple, Texas, 미국, 76504
    - Veterans Affairs Medical Center - Temple
  - Temple, Texas, 미국, 76508
    - CCOP - Scott and White Hospital
- Utah
  - Salt Lake City, Utah, 미국, 84148
    - Veterans Affairs Medical Center - Salt Lake City
  - Salt Lake City, Utah, 미국, 84112
    - Huntsman Cancer Institute
- Washington
  - Seattle, Washington, 미국, 98101
    - CCOP - Virginia Mason Research Center
  - Seattle, Washington, 미국, 98104
    - Swedish Cancer Institute
  - Seattle, Washington, 미국, 98108
    - Veterans Affairs Medical Center - Seattle
  - Tacoma, Washington, 미국, 98431-5000
    - Madigan Army Medical Center
  - Tacoma, Washington, 미국, 98405-0986
    - CCOP - Northwest

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

주 목적: 치료
할당: 무작위

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Southwest Oncology Group

협력자

National Cancer Institute (NCI)

수사관

연구 의자: Stephen K. Williamson, MD, University of Kansas

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

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.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2000년 11월 1일

연구 완료 (실제)

2006년 4월 1일

연구 등록 날짜

최초 제출

2000년 11월 6일

QC 기준을 충족하는 최초 제출

2003년 5월 30일

처음 게시됨 (추정)

2003년 6월 2일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2013년 6월 24일

QC 기준을 충족하는 마지막 업데이트 제출

2013년 6월 20일

마지막으로 확인됨

2002년 1월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

CDR0000068315
SWOG-S0003

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .