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S0414 Cetuximab, Combo Chemo, and RT in Locally Advanced Esophageal Cancer

2015년 11월 16일 업데이트: Southwest Oncology Group

Cetuximab Plus Cisplatin, Irinotecan and Thoracic Radiotherapy (TRT) for Locally Advanced (Non-Metastatic), Clinically Unresectable Esophageal Cancer: A Phase II Trial With Molecular Correlates

RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Cetuximab may also stop the growth of esophageal cancer by blocking blood flow to the tumor and by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cisplatin and irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving cetuximab together with combination chemotherapy and radiation therapy may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving cetuximab together with combination chemotherapy and radiation therapy works in treating patients with locally advanced esophageal cancer that cannot be removed by surgery.

연구 개요

상세 설명

OBJECTIVES:

Primary

  • Determine the 2-year overall survival of patients with previously untreated, clinically unresectable, locally advanced squamous cell carcinoma or adenocarcinoma of the esophagus treated with cetuximab, cisplatin, irinotecan, and thoracic radiotherapy.

Secondary

  • Determine the toxicity profile of this regimen in these patients.
  • Determine the probability of objective response (confirmed and unconfirmed, complete and partial) in patients with measurable disease treated with this regimen.
  • Determine the time to progression in patients with measurable disease treated with this regimen.
  • Correlate, preliminarily, gene expression (RNA) levels and germline polymorphisms of genes involved in DNA repair (e.g., ECRCC-1 and XRCC-1), drug metabolism (e.g., UGT1A1), and the epidermal growth factor receptor (EGFR) pathway (e.g., EGFR, interleukin-8, and vascular endothelial growth factor) with response, time to progression, overall survival, and toxicity in patients treated with this regimen. (This will not be completed as this study was closed due to poor accrual.)

OUTLINE: This is a multicenter study.

Patients receive cetuximab intravenous (IV) over 1-2 hours on days 1, 8, and 15. Patients also receive cisplatin IV and irinotecan IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Beginning on day 1 of course 3, patients undergo thoracic radiotherapy once daily 5 days a week for 5-6 weeks (total of 28 treatments).

After completion of study treatment, patients are followed at 4 weeks and then every 3-6 months for up to 5 years after study entry.

PROJECTED ACCRUAL: A total of 75-100 patients (75 with adenocarcinoma and 25 with squamous cell carcinoma) will be accrued for this study.

연구 유형

중재적

등록 (실제)

22

단계

  • 2 단계

연락처 및 위치

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

연구 장소

    • Alabama
      • Mobile, Alabama, 미국, 36652-2144
        • Mobile Infirmary Medical Center
    • Arkansas
      • Little Rock, Arkansas, 미국, 72205
        • Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
    • California
      • Berkeley, California, 미국, 94704
        • Alta Bates Comprehensive Cancer Center
      • Burbank, California, 미국, 91505
        • Providence Saint Joseph Medical Center - Burbank
      • Burlingame, California, 미국, 94010
        • Peninsula Medical Center
      • Castro Valley, California, 미국, 94546
        • Eden Medical Center
      • Greenbrae, California, 미국, 94904
        • Marin Cancer Institute at Marin General Hospital
      • Greenbrae, California, 미국, 94904
        • Sutter Health - Western Division Cancer Research Group
      • Hayward, California, 미국, 94545
        • Saint Rose Hospital
      • Los Angeles, California, 미국, 90089-9181
        • USC/Norris Comprehensive Cancer Center and Hospital
      • Oakland, California, 미국, 94609
        • Alta Bates Summit Medical Center - Summit Campus
      • Oakland, California, 미국, 94602
        • Highland General Hospital
      • Oakland, California, 미국, 94609
        • CCOP - Bay Area Tumor Institute
      • Palm Springs, California, 미국, 92262
        • Desert Regional Medical Center Comprehensive Cancer Center
      • Pleasanton, California, 미국, 94588
        • Valley Care Medical Center
      • 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
        • Doctors Medical Center - San Pablo Campus
      • Sana Rosa, California, 미국, 95405
        • CCOP - Santa Rosa Memorial Hospital
      • Vallejo, California, 미국, 94589
        • Sutter Solano Medical Center
    • Colorado
      • Fort Collins, Colorado, 미국, 80524
        • Poudre Valley Hospital
    • Florida
      • Lakeland, Florida, 미국, 33804-5000
        • Watson Clinic, LLC
    • Georgia
      • Augusta, Georgia, 미국, 30901
        • Augusta Oncology Associates - Walton Way
      • Savannah, Georgia, 미국, 31403-3089
        • Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
      • Savannah, Georgia, 미국, 31405
        • Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler
    • Idaho
      • Boise, Idaho, 미국, 83712
        • St. Luke's Mountain States Tumor Institute - Boise
    • Illinois
      • Springfield, Illinois, 미국, 62781-0001
        • Regional Cancer Center at Memorial Medical Center
    • Indiana
      • Beech Grove, Indiana, 미국, 46107
        • St. Francis Hospital and Health Centers - Beech Grove Campus
      • Richmond, Indiana, 미국, 47374
        • Reid Hospital & Health Care Services, Incorporated
    • Kansas
      • Chanute, Kansas, 미국, 66720
        • Cancer Center of Kansas, PA - Chanute
      • Dodge City, Kansas, 미국, 67801
        • Cancer Center of Kansas, PA - Dodge City
      • El Dorado, Kansas, 미국, 67042
        • Cancer Center of Kansas, PA - El Dorado
      • Kansas City, Kansas, 미국, 66160-7357
        • Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
      • Kingman, Kansas, 미국, 67068
        • Cancer Center of Kansas, PA - Kingman
      • Liberal, Kansas, 미국, 67901
        • Southwest Medical Center
      • Newton, Kansas, 미국, 67114
        • Cancer Center of Kansas, PA - Newton
      • Parsons, Kansas, 미국, 67357
        • Cancer Center of Kansas, PA - Parsons
      • Pratt, Kansas, 미국, 67124
        • Cancer Center of Kansas, PA - Pratt
      • Salina, Kansas, 미국, 67042
        • Cancer Center of Kansas, PA - Salina
      • Salina, Kansas, 미국, 67401
        • Tammy Walker Cancer Center at Salina Regional Health Center
      • Wellington, Kansas, 미국, 67152
        • Cancer Center of Kansas, PA - Wellington
      • Wichita, Kansas, 미국, 67214
        • Wesley Medical Center
      • Wichita, Kansas, 미국, 67203
        • Associates in Womens Health, PA - North Review
      • Wichita, Kansas, 미국, 67208
        • Cancer Center of Kansas, PA - Medical Arts Tower
      • Wichita, Kansas, 미국, 67214
        • Cancer Center of Kansas, PA - Wichita
      • Wichita, Kansas, 미국, 67214
        • CCOP - Wichita
      • Wichita, Kansas, 미국, 67214
        • Via Christi Cancer Center at Via Christi Regional Medical Center
      • Winfield, Kansas, 미국, 67156
        • Cancer Center of Kansas, PA - Winfield
    • Kentucky
      • Lexington, Kentucky, 미국, 40536-0293
        • Markey Cancer Center at University of Kentucky Chandler Medical Center
    • Michigan
      • Ann Arbor, Michigan, 미국, 48109-0942
        • University of Michigan Comprehensive Cancer Center
      • Battle Creek, Michigan, 미국, 49017
        • Battle Creek Health System Cancer Care Center
      • Big Rapids, Michigan, 미국, 49307
        • Mecosta County Medical Center
      • Detroit, Michigan, 미국, 48202
        • Josephine Ford Cancer Center at Henry Ford Hospital
      • Grand Rapids, Michigan, 미국, 49503
        • CCOP - Grand Rapids
      • Grand Rapids, Michigan, 미국, 49503
        • Lacks Cancer Center at Saint Mary's Health Care
      • Grand Rapids, Michigan, 미국, 49506
        • Metro Health Hospital
      • Grand Rapids, Michigan, 미국, 49503
        • Spectrum Health Hospital - Butterworth Campus
      • Holland, Michigan, 미국, 49423
        • Holland Community Hospital
      • Muskegon, Michigan, 미국, 49442
        • Hackley Hospital
      • Traverse City, Michigan, 미국, 49684
        • Munson Medical Center
    • Missouri
      • Kansas City, Missouri, 미국, 64131
        • CCOP - Kansas City
      • Saint Louis, Missouri, 미국, 63110
        • Saint Louis University Cancer Center
      • Springfield, Missouri, 미국, 65802
        • CCOP - Cancer Research for the Ozarks
      • Springfield, Missouri, 미국, 65804
        • St. John's Regional Health Center
      • Springfield, Missouri, 미국, 65807
        • Hulston Cancer Center at Cox Medical Center South
    • Montana
      • Billings, Montana, 미국, 59101
        • CCOP - Montana Cancer Consortium
      • Billings, Montana, 미국, 59101
        • Hematology-Oncology Centers of the Northern Rockies - Billings
      • Billings, Montana, 미국, 59101
        • Northern Rockies Radiation Oncology Center
      • Billings, Montana, 미국, 59101
        • St. Vincent Healthcare Cancer Care Services
      • Billings, Montana, 미국, 59107-7000
        • Billings Clinic - Downtown
      • Bozeman, Montana, 미국, 59715
        • Bozeman Deaconess Cancer Center
      • Butte, Montana, 미국, 59701
        • St. James Healthcare Cancer Care
      • Great Falls, Montana, 미국, 59405
        • Great Falls Clinic - Main Facility
      • Great Falls, Montana, 미국, 59405
      • Helena, Montana, 미국, 59601
        • St. Peter's Hospital
      • Kalispell, Montana, 미국, 59901
        • Kalispell Regional Medical Center
      • Kalispell, Montana, 미국, 59901
        • Glacier Oncology, PLLC
      • Kalispell, Montana, 미국, 59901
        • Kalispell Medical Oncology at KRMC
      • Missoula, Montana, 미국, 59801
        • Community Medical Center
      • Missoula, Montana, 미국, 59804
        • Guardian Oncology and Center for Wellness
      • Missoula, Montana, 미국, 59807-7877
        • Montana Cancer Specialists at Montana Cancer Center
      • Missoula, Montana, 미국, 59807
        • Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
    • Nebraska
      • Kearney, Nebraska, 미국, 68848-1990
        • Good Samaritan Cancer Center at Good Samaritan Hospital
    • New York
      • Rochester, New York, 미국, 14642
        • James P. Wilmot Cancer Center at University of Rochester Medical Center
      • Rochester, New York, 미국, 14623
        • Interlakes Oncology/Hematology PC
    • North Carolina
      • Goldsboro, North Carolina, 미국, 27534
        • Wayne Memorial Hospital, Incorporated
    • Ohio
      • Akron, Ohio, 미국, 44307
        • McDowell Cancer Center at Akron General Medical 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
      • Findlay, Ohio, 미국, 45840
        • Blanchard Valley Medical Associates
      • Kettering, Ohio, 미국, 45429
        • Charles F. Kettering Memorial Hospital
      • Middletown, Ohio, 미국, 45044
        • Middletown Regional Hospital
      • Troy, Ohio, 미국, 45373-1300
        • UVMC Cancer Care Center at Upper Valley Medical Center
      • Xenia, Ohio, 미국, 45385
        • Ruth G. McMillan Cancer Center at Greene Memorial Hospital
    • Oregon
      • Gresham, Oregon, 미국, 97030
        • Legacy Mount Hood Medical Center
      • Milwaukie, Oregon, 미국, 97222
        • Providence Milwaukie Hospital
      • Portland, Oregon, 미국, 97227
        • Northwest Cancer Specialists at Rose Quarter Cancer Center
      • Portland, Oregon, 미국, 97213-2967
        • Providence Cancer Center at Providence Portland Medical Center
      • Portland, Oregon, 미국, 97225
        • CCOP - Columbia River Oncology Program
      • Portland, Oregon, 미국, 97225
        • Providence St. Vincent Medical Center
      • Portland, Oregon, 미국, 97210
        • Legacy Good Samaritan Hospital & Medical Center Comprehensive Cancer Center
      • Portland, Oregon, 미국, 97227
        • Legacy Emanuel Hospital and Health Center & Children's Hospital
      • Portland, Oregon, 미국, 97239-3098
        • Oregon Health & Science University Cancer Institute
      • Salem, Oregon, 미국, 97309-5014
        • Salem Hospital Regional Cancer Care Services
      • Tualatin, Oregon, 미국, 97062
        • Legacy Meridian Park Hospital
    • South Carolina
      • Charleston, South Carolina, 미국, 29425
        • Hollings Cancer Center at Medical University of South Carolina
      • Charleston, South Carolina, 미국, 29401
        • Roper St. Francis Cancer Center at Roper Hospital
      • Greenville, South Carolina, 미국, 29615
        • CCOP - Greenville
    • Tennessee
      • Kingsport, Tennessee, 미국, 37662
        • Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center
      • Knoxville, Tennessee, 미국, 37920-6999
        • U.T. Cancer Institute at University of Tennessee Medical Center
    • Virginia
      • Danville, Virginia, 미국, 24541
        • Danville Regional Medical Center
      • Norton, Virginia, 미국, 24273
        • Southwest Virginia Regional Cancer Center
    • Washington
      • Bellingham, Washington, 미국, 98225
        • St. Joseph Cancer Center
      • Bremerton, Washington, 미국, 98310
        • Olympic Hematology and Oncology
      • Kennewick, Washington, 미국, 99336
        • Columbia Basin Hematology
      • Mt. Vernon, Washington, 미국, 98273
        • Skagit Valley Hospital Cancer Care Center
      • Seattle, Washington, 미국, 98104
        • Harborview Medical Center
      • Seattle, Washington, 미국, 98104
        • Fred Hutchinson Cancer Research Center
      • Seattle, Washington, 미국, 98104
        • Minor and James Medical, PLLC
      • Seattle, Washington, 미국, 98112
        • Group Health Central Hospital
      • Seattle, Washington, 미국, 98122-4307
        • Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
      • Seattle, Washington, 미국, 98122
        • Polyclinic First Hill
      • Seattle, Washington, 미국, 98195-6043
        • University Cancer Center at University of Washington Medical Center
      • Spokane, Washington, 미국, 99202
        • Cancer Care Northwest - Spokane South
      • Vancouver, Washington, 미국, 98684
        • Northwest Cancer Specialists at Vancouver Cancer Center
      • Vancouver, Washington, 미국, 98668
        • Southwest Washington Medical Center Cancer Center
      • Wenatchee, Washington, 미국, 98801-2028
        • Wenatchee Valley Medical Center
    • Wyoming
      • Sheridan, Wyoming, 미국, 82801
        • Welch Cancer Center at Sheridan Memorial Hospital

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 confirmed primary squamous cell carcinoma or adenocarcinoma of the thoracic esophagus (≥ 20 cm from the incisors*) or the gastroesophageal junction (confined to ≤ 2 cm into the gastric cardia)

    • Disease confined to the esophagus or peri-esophageal soft tissue
    • T4, M0 disease
    • Surgically unresectable disease by esophageal endoscopic ultrasonography OR medically unresectable disease

NOTE: *Patients with primary disease < 26 cm from the incisors must undergo bronchoscopy AND have negative cytology within the past 4 weeks

  • Measurable or non-measurable disease by x-ray, CT scan and/or MRI, or physical examination within the past 4 weeks (for measurable disease) or within the past 6 weeks (for non-measurable disease)
  • Tumor specimens available
  • No recurrent disease

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • Zubrod 0-2

Life expectancy

  • Not specified

Hematopoietic

  • Absolute neutrophil count (ANC) ≥ 1,500/mm^3
  • White Blood Cell (WBC) count ≥ 3,000/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 10.0 g/dL

Hepatic

  • Albumin normal
  • Bilirubin normal
  • Alkaline phosphatase normal
  • Serum glutamic oxaloacetic transaminase (SGOT) or Serum glutamic pyruvic transaminase (SGPT) ≤ 2.5 times upper limit of normal

Renal

  • Creatinine clearance > 50 mL/min

Other

  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No prior severe reaction to monoclonal antibodies
  • No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • No prior chemotherapy for esophageal cancer

Endocrine therapy

  • Not specified

Radiotherapy

  • No prior radiotherapy for esophageal cancer
  • No concurrent intensity modulated radiotherapy
  • No concurrent cobalt-60

Surgery

  • No prior surgical resection or attempted surgical resection of esophageal cancer

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: 해당 없음
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Treatment
Cetuximab+Cisplatin+Irinotecan followed by radiation therapy (RT) in Cycle 3.
400mg/m^2 loading dose, intravenous (IV) over 120 min, day 1 of cycle 1 only. 250mg/m^2 maintenance dose, IV over 60 min, Days 8 & 15 of Cycle 1 and Days 1, 8, and 15 of subsequent cycles.
다른 이름들:
  • 얼비툭스
30mg/m^2, bolus intravenous (IV), on Days 1 & 8 of each cycle.
다른 이름들:
  • 플라티놀
65mg/m^2, intravenous (IV) over 30 min, on Days 1 & 8 of each cycle.
다른 이름들:
  • CPT-11
The total dose to the prescription point will be 5,040 cGy given in 28 fractions. The patient will be treated with one fraction per day with all fields treated per day. 180 cGy will be delivered to the isocenter. The dose variation in the planning target volume (PTV) will be +7% and -5% of the prescription point dose.
다른 이름들:
  • RT
  • TRT

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Overall Survival at 2 Years
기간: 0-2 years
Measured from time of registration to date of death due to any cause, or last contact date
0-2 years

2차 결과 측정

결과 측정
측정값 설명
기간
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
기간: Patients were assessed for adverse events after every two cycles of chemotherapy.
Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.
Patients were assessed for adverse events after every two cycles of chemotherapy.
Objective Response (Confirmed and Unconfined, Complete and Partial)
기간: at week 16, then every 3 months until progression
Complete response (CR) is complete disappearance of all measurable and non-measurable disease. No new lesions. No disease related symptoms. Normalization of markers and other abnormal lab values. Partial response (PR) applies only to patients with at least one measurable lesion. Greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions. No unequivocal progression of non-measurable disease. No new lesions. Confirmation of CR or PR means a repeat scan at least 4 weeks apart documented before progression or symptomatic deterioration.
at week 16, then every 3 months until progression
Progression Free Survival
기간: 0 - 5 years
Measured from date of registration to date of first observation of progression or symptomatic deterioration. Patients last known to be alive and progression-free are censored at date of last contact.
0 - 5 years

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 연구 의자: Lisa Hammond, MD, The University of Texas Health Science Center at San Antonio
  • 연구 의자: Charles R. Thomas, MD, OHSU Knight Cancer Institute
  • 연구 의자: Charles D. Blanke, MD, FACP, OHSU Knight Cancer Institute
  • 연구 의자: Vivek Mehta, MD, Swedish Cancer Institute at Swedish Medical Center - First Hill Campus

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

2005년 5월 1일

기본 완료 (실제)

2009년 9월 1일

연구 완료 (실제)

2012년 5월 1일

연구 등록 날짜

최초 제출

2005년 5월 3일

QC 기준을 충족하는 최초 제출

2005년 5월 3일

처음 게시됨 (추정)

2005년 5월 4일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2015년 11월 18일

QC 기준을 충족하는 마지막 업데이트 제출

2015년 11월 16일

마지막으로 확인됨

2015년 11월 1일

추가 정보

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. .

식도암에 대한 임상 시험

cetuximab에 대한 임상 시험

구독하다