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S0342: Paclitaxel, Carboplatin, and Cetuximab in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer

2012년 10월 30일 업데이트: Southwest Oncology Group

Phase II Selection Design Trial Of Concurrent Chemotherapy + Cetuximab Vs. Chemotherapy Followed By Cetuximab In Advanced Non-Small Cell Lung Cancer (NSCLC)

RATIONALE: Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as cetuximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining more than one chemotherapy drug with a monoclonal antibody may kill more tumor cells. It is not yet known whether cetuximab is more effective when given at the same time as chemotherapy or following chemotherapy.

PURPOSE: This randomized phase II trial is studying how well giving cetuximab at the same time as combination chemotherapy works compared to giving cetuximab after combination chemotherapy in treating patients with stage IIIB or stage IV non-small cell lung cancer.

연구 개요

상태

완전한

정황

개입 / 치료

상세 설명

OBJECTIVES:

Primary

  • Compare overall survival of patients with selected stage IIIB or stage IV non-small cell lung cancer treated with concurrent vs sequential paclitaxel, carboplatin, and cetuximab.

Secondary

  • Compare response rates (confirmed and unconfirmed, complete and partial) in patients treated with these regimens.
  • Compare the toxic effects of these regimens in these patients.
  • Correlate epidermal growth factor receptor polymorphisms and downstream biomarkers with response to cetuximab in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.

  • Arm I (concurrent cetuximab): Patients receive cetuximab IV over 1 hour (over 2 hours on day 1 of course 1 only) on days 1, 8, and 15 and paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 8. Treatment repeats every 21 days for a total of 4 courses (12 weeks) in the absence of disease progression or unacceptable toxicity. Beginning on week 13, patients receive single-agent cetuximab IV over 1 hour once weekly in the absence of disease progression or unacceptable toxicity.
  • Arm II (sequential cetuximab): Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for a total of 4 courses (12 weeks) in the absence of disease progression or unacceptable toxicity. Beginning on week 13, patients receive single-agent cetuximab IV over 1 hour (over 2 hours on week 13 only) once weekly in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 1 year and then every 6 months for 2 years.

PROJECTED ACCRUAL: A total of 180 patients (90 per treatment arm) will be accrued for this study within 9 months.

연구 유형

중재적

등록 (실제)

242

단계

  • 2 단계

연락처 및 위치

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

연구 장소

  • 미국
    • Alaska
      • Anchorage, Alaska, 미국, 99508
        • Alaska Regional Hospital
    • Arkansas
      • Little Rock, Arkansas, 미국, 72205
        • Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
    • California
      • Berkeley, California, 미국, 94705
        • Alta Bates Comprehensive Cancer Center
      • Burlingame, California, 미국, 94010
        • Peninsula Medical Center
      • Duarte, California, 미국, 91010
        • City of Hope Comprehensive Cancer Center
      • Greenbrae, California, 미국, 94904
        • Sutter Health Western Division Cancer Research Group
      • Greenbrae, California, 미국, 94904
        • Marin Cancer Institute at Marin General Hospital
      • Hayward, California, 미국, 94545
        • Saint Rose Hospital
      • Livermore, California, 미국, 94550
        • Valley Memorial Hospital
      • Los Angeles, California, 미국, 90033-0804
        • USC/Norris Comprehensive Cancer Center and Hospital
      • Oakland, California, 미국, 94602
        • Highland General Hospital
      • Oakland, California, 미국, 94609
        • CCOP - Bay Area Tumor Institute
      • Oakland, California, 미국, 94609
        • Summit Medical Center
      • Palm Springs, California, 미국, 92262
        • Comprehensive Cancer Center at Desert Regional Medical Center
      • Roseville, California, 미국, 95661
        • Sutter Roseville Medical Center
      • Sacramento, California, 미국, 95816
        • Sutter Cancer center
      • Sacramento, California, 미국, 95819
        • Mercy General Hospital
      • Sacramento, California, 미국, 95817
        • University of California Davis Cancer Center
      • San Francisco, California, 미국, 94118
        • California Pacific Medical Center - California Campus
      • San Pablo, California, 미국, 94806
        • J.C. Robinson, M.D. Regional Cancer Center
      • Sana Rosa, California, 미국, 95405
        • CCOP - Santa Rosa Memorial Hospital
    • Colorado
      • Denver, Colorado, 미국, 80220
        • Veterans Affairs Medical Center - Denver
      • Denver, Colorado, 미국, 80204
        • St. Anthony Central Hospital
      • Denver, Colorado, 미국, 80217-3364
        • University of Colorado Cancer Center at University of Colorado Health Sciences Center
      • Fort Collins, Colorado, 미국, 80524
        • Poudre Valley Hospital
      • Montrose, Colorado, 미국, 81401
        • Montrose Memorial Hospital Cancer Center
      • Westminster, Colorado, 미국, 80030
        • St. Anthony North Hospital
      • Wheat Ridge, Colorado, 미국, 80033
        • Exempla Lutheran Medical Center
    • Georgia
      • Atlanta, Georgia, 미국, 30309
        • Piedmont Hospital
      • Atlanta, Georgia, 미국, 30342
        • Saint Joseph's Hospital of Atlanta
      • Atlanta, Georgia, 미국, 30342
        • CCOP - Atlanta Regional
      • Atlanta, Georgia, 미국, 30342
        • Northside Hospital Cancer Center
      • Augusta, Georgia, 미국, 30901
        • Augusta Oncology Associates
      • Austell, Georgia, 미국, 30106
        • WellStar Cobb Hospital
      • Decatur, Georgia, 미국, 30033
        • Charles B. Eberhart Cancer Center at DeKalb Medical Center
      • Gainesville, Georgia, 미국, 30501
        • Northeast Georgia Medical Center
      • Lawrenceville, Georgia, 미국, 30045
        • Gwinnett Medical Center
      • Marietta, Georgia, 미국, 30060
        • Kennestone Cancer Center at Wellstar Kennestone Hospital
      • Riverdale, Georgia, 미국, 30274
        • Southern Regional Medical Center
      • Savannah, Georgia, 미국, 31403
        • Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
      • Valdosta, Georgia, 미국, 31603
        • Pearlman Comprehensive Cancer Center at South Georgia Medical Center
    • Hawaii
      • Aiea, Hawaii, 미국, 96701
        • Kapiolani Medical Center at Pali Momi
      • Honolula, Hawaii, 미국, 96813
        • Cancer Research Center of Hawaii
      • Honolulu, Hawaii, 미국, 96826
        • Kapiolani Medical Center for Women and Children
      • Honolulu, Hawaii, 미국, 96813
        • OnCare Hawaii, Incorporated - Lusitana
      • Honolulu, Hawaii, 미국, 96813
        • Queen's Cancer Institute at Queen's Medical Center
      • Honolulu, Hawaii, 미국, 96813
        • Straub Clinic and Hospital, Incorporated
      • Honolulu, Hawaii, 미국, 96817
        • OnCare Hawaii, Incorporated - Kuakini
      • Honolulu, Hawaii, 미국, 96817
        • St. Francis Medical Center
    • Idaho
      • Boise, Idaho, 미국, 83712
        • St. Luke's Mountain States Tumor Institute - Boise
    • Illinois
      • Alton, Illinois, 미국, 62002
        • Saint Anthony's Hospital at Saint Anthony's Health Center
      • Maywood, Illinois, 미국, 60153
        • Cardinal Bernardin Cancer Center at Loyola University Medical Center
      • Naperville, Illinois, 미국, 60540
        • Hematology Oncology Consultants Ltd.
      • Naperville, Illinois, 미국, 60566
        • Edward Hospital Cancer Center
    • Indiana
      • Beech Grove, Indiana, 미국, 46107
        • St. Francis Hospital and Health Centers
    • Iowa
      • Davenport, Iowa, 미국, 52804
        • Genesis Medical Center - West Campus
      • Davenport, Iowa, 미국, 52803
        • Genesis Regional Cancer Center at Genesis Medical Center
    • Kansas
      • Kansas City, Kansas, 미국, 66160
        • Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
      • Salina, Kansas, 미국, 67401
        • Salina Regional Health Center
      • Wichita, Kansas, 미국, 67214
        • Via Christi Cancer Center at Via Christi Regional Medical Center
    • Louisiana
      • New Orleans, Louisiana, 미국, 70112
        • Tulane Cancer Center
      • Shreveport, Louisiana, 미국, 71101
        • Cancer Treatment Center at Christus Schumpert St. Mary Place
    • Massachusetts
      • Boston, Massachusetts, 미국, 02118
        • Cancer Research Center at Boston Medical Center
    • Michigan
      • Ann Arbor, Michigan, 미국, 48109
        • University of Michigan Comprehensive Cancer Center
      • Ann Arbor, Michigan, 미국, 48106-0995
        • St. Joseph Mercy Cancer Center at St. Joseph Mercy Hospital
      • Ann Arbor, Michigan, 미국, 48100
        • CCOP - Michigan Cancer Research Consortium
      • Battle Creek, Michigan, 미국, 49017
        • Cancer Care Center at Battle Creek Health System
      • Bay City, Michigan, 미국, 48708
        • Bay Regional Medical Center
      • Big Rapids, Michigan, 미국, 49307
        • Mecosta County General Hospital
      • Detroit, Michigan, 미국, 48202
        • Josephine Ford Cancer Center at Henry Ford Health System
      • Flint, Michigan, 미국, 48532
        • Genesys Hurley Cancer Institute
      • Grand Rapids, Michigan, 미국, 49503
        • CCOP - Grand Rapids
      • Grand Rapids, Michigan, 미국, 49503
        • Lacks Cancer Center at Saint Mary's Mercy Medical Center
      • Grand Rapids, Michigan, 미국, 49503
        • Spectrum Health Cancer Care - Butterworth Campus
      • Grand Rapids, Michigan, 미국, 49506
        • Metropolitan Hospital
      • Grand Rapids, Michigan, 미국, 49506
        • Spectrum Health Hospital - Blodgett Campus
      • Holland, Michigan, 미국, 49423
        • Holland Community Hospital
      • Mount Clemens, Michigan, 미국, 48043
        • Mount Clemens General Hospital
      • Muskegon, Michigan, 미국, 49443
        • Hackley Hospital
      • Petoskey, Michigan, 미국, 49770
        • Northern Michigan Hospital
      • Pontiac, Michigan, 미국, 48341-2985
        • St. Joseph Mercy Hospital
      • Saginaw, Michigan, 미국, 48601
        • Seton Cancer Institute - Saginaw
      • Traverse City, Michigan, 미국, 49684
        • Munson Medical Center
      • Warren, Michigan, 미국, 48903
        • St. John Macomb Hospital
    • Mississippi
      • Jackson, Mississippi, 미국, 39216
        • University of Mississippi Medical Center
      • Kessler AFB, Mississippi, 미국, 39534-2519
        • Keesler Medical Center - Keesler Air Force Base
    • Missouri
      • Cape Girardeau, Missouri, 미국, 63701
        • St. Francis Medical Center
      • Gape Girardeau, Missouri, 미국, 63701
        • Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital
      • Joplin, Missouri, 미국, 64804
        • Freeman Cancer Institute at Freeman Health System
      • Springfield, Missouri, 미국, 65804
        • St. John's Regional Health Center
      • Springfield, Missouri, 미국, 65807
        • Hulston Cancer Center at Cox Medical Center South
      • St. Louis, Missouri, 미국, 63141
        • CCOP - St. Louis-Cape Girardeau
      • St. Louis, Missouri, 미국, 63141
        • David C. Pratt Cancer Center at St. John's Mercy
    • Montana
      • Billings, Montana, 미국, 59101
        • CCOP - Montana Cancer Consortium
      • Great Falls, Montana, 미국, 59405
        • Great Falls Clinic
      • Great Falls, Montana, 미국, 59405
        • Big Sky Oncology
      • Great Falls, Montana, 미국, 59405
        • Sletten Regional Cancer Institute
    • New Jersey
      • Ridgewood, New Jersey, 미국, 07450
        • Valley Hospital - Ridgewood
    • New York
      • Glens Falls, New York, 미국, 12801
        • Adirondack Cancer Care
      • Rochester, New York, 미국, 14642
        • James P. Wilmot Cancer Center at University of Rochester Medical Center
    • North Carolina
      • Charlotte, North Carolina, 미국, 28203
        • Blumenthal Cancer Center at Carolinas Medical Center
      • Goldsboro, North Carolina, 미국, 27534
        • Wayne Memorial Hospital, Incorporated
      • Hendersonville, North Carolina, 미국, 28791
        • Pardee Memorial Hospital
      • Rutherfordton, North Carolina, 미국, 28139
        • Rutherford Hospital
    • Ohio
      • Akron, Ohio, 미국, 44307
        • McDowell Cancer Center at Akron General Medical Center
      • Cincinnati, Ohio, 미국, 45220
        • Tri-Health Good Samaritan Hospital
      • Cleveland, Ohio, 미국, 44195
        • Cleveland Clinic Taussig Cancer Center
      • Dayton, Ohio, 미국, 45428
        • Veterans Affairs Medical Center - Dayton
      • Dayton, Ohio, 미국, 45405
        • Grandview Hospital
      • Dayton, Ohio, 미국, 45406
        • Good Samaritan Hospital
      • Dayton, Ohio, 미국, 45409
        • David L. Rike Cancer Center at Miami Valley Hospital
      • Dayton, Ohio, 미국, 45415
        • Samaritan North Cancer Care Center
      • Dayton, Ohio, 미국, 45429
        • CCOP - Dayton
      • Independence, Ohio, 미국, 44131
        • Community Oncology Group - Independence
      • Kettering, Ohio, 미국, 45429
        • Charles F. Kettering Memorial Hospital
      • Mansfield, Ohio, 미국, 44903
        • MedCentral - Mansfield Hospital
      • Middletown, Ohio, 미국, 45044
        • Middletown Regional Hospital
      • Troy, Ohio, 미국, 45373
        • UVMC Cancer Care Center at Upper Valley Medical Center
      • Wooster, Ohio, 미국, 44691
        • Cleveland Clinic - Wooster
      • Wright-Patterson Afb, Ohio, 미국, 45433-5529
        • United States Air Force Medical Center Wright-Patterson
      • Xenia, Ohio, 미국, 45385
        • Ruth G. McMillan Cancer Center at Greene Memorial Hospital
    • Oregon
      • Bend, Oregon, 미국, 97701
        • St. Charles Medical Center
      • Glesham, Oregon, 미국, 97030
        • Legacy Mount Hood Medical Center
      • Milwaukie, Oregon, 미국, 97222
        • Providence Milwaukie Hospital
      • Portland, Oregon, 미국, 97225
        • CCOP - Columbia River Oncology Program
      • Portland, Oregon, 미국, 97225
        • Providence St. Vincent Medical Center
      • Portland, Oregon, 미국, 97210
        • Comprehensive Cancer Center at Legacy Good Samaritan Hospital & Medical Center
      • Portland, Oregon, 미국, 97213
        • Providence Cancer Center at Providence Portland Medical Center
      • Portland, Oregon, 미국, 97227
        • Institute of Oncology at Vilnius University
      • Salem, Oregon, 미국, 97309
        • Salem Hospital Regional Cancer Center
      • Tualatin, Oregon, 미국, 97062
        • Legacy Meridian Park Hospital
    • South Carolina
      • Anderson, South Carolina, 미국, 29621
        • Rose Ramer Cancer Clinic at Anderson Area Medical Center
      • Charleston, South Carolina, 미국, 29425
        • Hollings Cancer Center at Medical University of South Carolina
      • Florence, South Carolina, 미국, 29506
        • McLeod Regional Medical Center
      • Greenville, South Carolina, 미국, 29615
        • CCOP - Greenville
      • Greenville, South Carolina, 미국, 29601
        • Bon Secours St. Francis Health System
      • Greenville, South Carolina, 미국, 29605
        • Greenville Hospital System Cancer Center
      • Spartanburg, South Carolina, 미국, 29303
        • Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
      • Spartanburg, South Carolina, 미국, 29304
        • CCOP - Upstate Carolina
    • Tennessee
      • Knoxville, Tennessee, 미국, 37916
        • Thompson Cancer Survival Center
    • Texas
      • Arlington, Texas, 미국, 76012
        • Arlington Cancer Center - Arlington
      • Fort Sam Houston, Texas, 미국, 78234
        • Brooke Army Medical Center
      • Lackland AFB, Texas, 미국, 78236
        • Wilford Hall Medical Center
      • Lubbock, Texas, 미국, 79415
        • UMC Southwest Cancer and Research Center
    • Utah
      • Salt Lake City, Utah, 미국, 84112
        • Huntsman Cancer Institute at University of Utah
    • Virginia
      • Danville, Virginia, 미국, 24541
        • Danville Regional Medical Center
      • Martinsville, Virginia, 미국, 24115
        • Memorial Hospital of Martinsville and Henry County
    • Washington
      • Bellingham, Washington, 미국, 98225
        • St. Joseph Hospital Community Cancer Center
      • Bremerton, Washington, 미국, 98310
        • Olympic Hematology and Oncology
      • Mt. Vernon, Washington, 미국, 98273
        • Cancer Care Center at Skagit Valley Hospital
      • Seattle, Washington, 미국, 98104
        • Harborview Medical Center
      • Seattle, Washington, 미국, 98104
        • Fred Hutchinson Cancer Research Center
      • Seattle, Washington, 미국, 98195
        • University Cancer Center at University of Washington Medical Center
      • Seattle, Washington, 미국, 98104
        • Group Health Central Hospital
      • Seattle, Washington, 미국, 98114
        • Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
      • Spokane, Washington, 미국, 99202
        • Cancer Care Northwest - Spokane South
      • Spokane, Washington, 미국, 99204
        • Providence Cancer Center at Sacred Heart Medical Center
      • Spokane, Washington, 미국, 99207
        • Providence Cancer Center at Holy Family Hospital
      • Vancouver, Washington, 미국, 98668
        • Southwest Washington Medical Center Cancer Center
      • Wenatchee, Washington, 미국, 98801
        • Central Washington Hospital
      • Wenatchee, Washington, 미국, 98801
        • Wenatchee Valley Clinic
      • Yakima, Washington, 미국, 98902
        • North Star Lodge Cancer Center
      • Yakima, Washington, 미국, 98902
        • Washington Hematology - Oncology Specialists

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 confirmed non-small cell lung cancer (NSCLC) of one of the following stages:

    • Newly diagnosed selected stage IIIB disease (T4 lesion due to malignant pleural effusion, any N, M0)
    • Newly diagnosed stage IV disease (any T, any N, M1)
    • Recurrent stage IV disease after prior surgery or radiotherapy

  • The following subtypes are eligible:

    • Adenocarcinoma
    • Squamous cell carcinoma
    • Large cell carcinoma
    • Unspecified

  • Measurable disease by CT scan, MRI, x-ray, or physical exam

    • Pleural effusions, ascites, or laboratory parameters are not acceptable as the only evidence of disease
    • Not within prior radiotherapy field unless a new lesion is present
    • Not within area of prior surgical resection
  • No known brain metastases by CT scan or MRI

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • Zubrod 0-1

Life expectancy

  • Not specified

Hematopoietic

  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 9 mg/dL

Hepatic

  • Bilirubin ≤ 2 times upper limit of normal (ULN)
  • SGOT or SGPT ≤ 2 times ULN
  • Alkaline phosphatase ≤ 2 times ULN
  • No known acute hepatitis

Renal

  • Creatinine ≤ ULN
  • Creatinine clearance ≥ 50 mL/min

Cardiovascular

  • No significant cardiac disease
  • No uncontrolled hypertension
  • No unstable angina
  • No congestive heart failure

Other

  • 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 adequately treated stage I or II cancer currently in complete remission
  • No active or uncontrolled infection
  • No sensory neuropathy ≥ grade 2
  • No known human anti-mouse antibodies
  • Not pregnant or nursing
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No prior biologic therapy for NSCLC
  • No prior chimeric or murine monoclonal antibody therapy
  • No prior cetuximab

Chemotherapy

  • No prior systemic chemotherapy for NSCLC

Endocrine therapy

  • Not specified

Radiotherapy

  • See Disease Characteristics
  • At least 3 weeks since prior radiotherapy and recovered

Surgery

  • See Disease Characteristics
  • At least 2 weeks since prior thoracic or major surgery and recovered

Other

  • No prior gefitinib or other investigational agents that target the epidermal growth factor receptor pathway

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
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
활성 비교기: 2
의약품: cetuximab

Arm 1: 400 mg/m2 (Initial dose), 2 hour IV infusion on Day 1, Week 1 only. 250 mg/m2 (Subsequent doses), 1 hour IV infusion, on Day 1 weekly starting at Week 2.

Arm 2: 400 mg/m2 (Initial dose), 2 hour IV infusion on Week 13 ONLY 250 mg/m2 (Subsequent doses), 1 hour IV infusion, weekly starting at Week 14.

의약품: carboplatin

Arm 1: AUC=6 30 minute IV infusion immediately following paclitaxel on Day 1 q 21 days x 4 starting at Week 2

Arm 2: AUC=6 30 minute IV infusion immediately following paclitaxel on Day 1 q 21 days x 4 starting at Week 1

의약품: paclitaxel

Arm 1: 225 mg/m2 3 hour IV infusion 1 hour following cetuximab on Day 1, q 21 days x 4 Starting at Week 4.

Arm 2: 225 mg/m2 3 hour IV infusion 1 hour following cetuximab on Day 1, q 21 days x 4 Starting at Week 1.
활성 비교기: 1
의약품: cetuximab

Arm 1: 400 mg/m2 (Initial dose), 2 hour IV infusion on Day 1, Week 1 only. 250 mg/m2 (Subsequent doses), 1 hour IV infusion, on Day 1 weekly starting at Week 2.

Arm 2: 400 mg/m2 (Initial dose), 2 hour IV infusion on Week 13 ONLY 250 mg/m2 (Subsequent doses), 1 hour IV infusion, weekly starting at Week 14.

의약품: carboplatin

Arm 1: AUC=6 30 minute IV infusion immediately following paclitaxel on Day 1 q 21 days x 4 starting at Week 2

Arm 2: AUC=6 30 minute IV infusion immediately following paclitaxel on Day 1 q 21 days x 4 starting at Week 1

의약품: paclitaxel

Arm 1: 225 mg/m2 3 hour IV infusion 1 hour following cetuximab on Day 1, q 21 days x 4 Starting at Week 4.

Arm 2: 225 mg/m2 3 hour IV infusion 1 hour following cetuximab on Day 1, q 21 days x 4 Starting at Week 1.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Select a regimen based on overall survival
기간: From date of registration until the date of progression or date of death from any cause, whichever came first, assessed up to 3 years
To select a regimen based on overall survival via a Phase II selection design of chemotherapy in conjunction with cetuximab (concurrent vs. sequential) for Phase III testing against chemotherapy alone in Stage IIIB and Stage IV non-small cell lung cancer.
From date of registration until the date of progression or date of death from any cause, whichever came first, assessed up to 3 years
Response rate (confirmed and unconfirmed, complete and partial response)
기간: From date of registration until the date of progression or date of death from any cause, whichever came first, assessed up to 3 years
To evaluate response rates (confirmed and unconfirmed, complete and partial) of patients with selected Stage IIIB and Stage IV NSCLC treated with paclitaxel and carboplatin with concurrent cetuximab or paclitaxel and carboplatin followed by cetuximab.
From date of registration until the date of progression or date of death from any cause, whichever came first, assessed up to 3 years
Toxicities
기간: From date of registration until the date of progression or date of death from any cause, whichever came first, assessed up to 3 years
To evaluate the toxicities of the two treatment regimens in patients with selected Stage IIIB and Stage IV NSCLC.
From date of registration until the date of progression or date of death from any cause, whichever came first, assessed up to 3 years

2차 결과 측정

결과 측정
측정값 설명
기간
Correlation of epidermal growth factor receptor polymorphisms and downstream biomarkers with response
기간: At prestudy
To conduct exploratory molecular correlative studies of the EGFR-HER signaling pathways examining activated phosphoproteins, oncogenic mutations and rates of proliferation and apoptosis in patient tissues (see S9925 for details).
At prestudy
Evaluate EGFR polymorphisms
기간: At prestudy and week 5
To evaluate EGFR polymorphisms as a potential correlate for response to cetuximab (see S9925 for details).
At prestudy and week 5

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Southwest Oncology Group

협력자

National Cancer Institute (NCI)

수사관

  • 수석 연구원: Karen Kelly, MD, University of Colorado, Denver
  • 수석 연구원: Roy S. Herbst, MD, PhD, M.D. Anderson Cancer Center
  • 수석 연구원: David R. Gandara, MD, University of California, Davis

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

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

2004년 7월 1일

기본 완료 (실제)

2007년 8월 1일

연구 완료 (실제)

2011년 7월 1일

연구 등록 날짜

최초 제출

2004년 6월 10일

QC 기준을 충족하는 최초 제출

2004년 6월 10일

처음 게시됨 (추정)

2004년 6월 11일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2012년 11월 1일

QC 기준을 충족하는 마지막 업데이트 제출

2012년 10월 30일

마지막으로 확인됨

2012년 10월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • CDR0000370806
  • U10CA032102 (미국 NIH 보조금/계약)
  • S0342 (기타 식별자: SWOG)

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. .

폐암에 대한 임상 시험

cetuximab에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

CROs by country

CROs in Japan

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

구독하다