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

2015年11月16日 更新者：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.

研究概览

地位

终止

条件

干预/治疗

详细说明

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.

研究类型

介入性

注册 (实际的)

22

阶段

  • 阶段2

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 美国
    • Alabama
      • Mobile、Alabama、美国、36652-2144
        • Mobile Infirmary Medical Center
    • Arkansas
      • Little Rock、Arkansas、美国、72205
        • Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
    • California
      • Berkeley、California、美国、94704
        • Alta Bates Comprehensive Cancer Center
      • Burbank、California、美国、91505
        • Providence Saint Joseph Medical Center - Burbank
      • Burlingame、California、美国、94010
        • Peninsula Medical Center
      • Castro Valley、California、美国、94546
        • Eden Medical Center
      • Greenbrae、California、美国、94904
        • Marin Cancer Institute at Marin General Hospital
      • Greenbrae、California、美国、94904
        • Sutter Health - Western Division Cancer Research Group
      • Hayward、California、美国、94545
        • Saint Rose Hospital
      • Los Angeles、California、美国、90089-9181
        • USC/Norris Comprehensive Cancer Center and Hospital
      • Oakland、California、美国、94609
        • Alta Bates Summit Medical Center - Summit Campus
      • Oakland、California、美国、94602
        • Highland General Hospital
      • Oakland、California、美国、94609
        • CCOP - Bay Area Tumor Institute
      • Palm Springs、California、美国、92262
        • Desert Regional Medical Center Comprehensive Cancer Center
      • Pleasanton、California、美国、94588
        • Valley Care Medical Center
      • Sacramento、California、美国、95817
        • University of California Davis Cancer Center
      • San Francisco、California、美国、94118
        • California Pacific Medical Center - California Campus
      • San Pablo、California、美国、94806
        • Doctors Medical Center - San Pablo Campus
      • Sana Rosa、California、美国、95405
        • CCOP - Santa Rosa Memorial Hospital
      • Vallejo、California、美国、94589
        • Sutter Solano Medical Center
    • Colorado
      • Fort Collins、Colorado、美国、80524
        • Poudre Valley Hospital
    • Florida
      • Lakeland、Florida、美国、33804-5000
        • Watson Clinic, LLC
    • Georgia
      • Augusta、Georgia、美国、30901
        • Augusta Oncology Associates - Walton Way
      • Savannah、Georgia、美国、31403-3089
        • Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
      • Savannah、Georgia、美国、31405
        • Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler
    • Idaho
      • Boise、Idaho、美国、83712
        • St. Luke's Mountain States Tumor Institute - Boise
    • Illinois
      • Springfield、Illinois、美国、62781-0001
        • Regional Cancer Center at Memorial Medical Center
    • Indiana
      • Beech Grove、Indiana、美国、46107
        • St. Francis Hospital and Health Centers - Beech Grove Campus
      • Richmond、Indiana、美国、47374
        • Reid Hospital & Health Care Services, Incorporated
    • Kansas
      • Chanute、Kansas、美国、66720
        • Cancer Center of Kansas, PA - Chanute
      • Dodge City、Kansas、美国、67801
        • Cancer Center of Kansas, PA - Dodge City
      • El Dorado、Kansas、美国、67042
        • Cancer Center of Kansas, PA - El Dorado
      • Kansas City、Kansas、美国、66160-7357
        • Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
      • Kingman、Kansas、美国、67068
        • Cancer Center of Kansas, PA - Kingman
      • Liberal、Kansas、美国、67901
        • Southwest Medical Center
      • Newton、Kansas、美国、67114
        • Cancer Center of Kansas, PA - Newton
      • Parsons、Kansas、美国、67357
        • Cancer Center of Kansas, PA - Parsons
      • Pratt、Kansas、美国、67124
        • Cancer Center of Kansas, PA - Pratt
      • Salina、Kansas、美国、67042
        • Cancer Center of Kansas, PA - Salina
      • Salina、Kansas、美国、67401
        • Tammy Walker Cancer Center at Salina Regional Health Center
      • Wellington、Kansas、美国、67152
        • Cancer Center of Kansas, PA - Wellington
      • Wichita、Kansas、美国、67214
        • Wesley Medical Center
      • Wichita、Kansas、美国、67203
        • Associates in Womens Health, PA - North Review
      • Wichita、Kansas、美国、67208
        • Cancer Center of Kansas, PA - Medical Arts Tower
      • Wichita、Kansas、美国、67214
        • Cancer Center of Kansas, PA - Wichita
      • Wichita、Kansas、美国、67214
        • CCOP - Wichita
      • Wichita、Kansas、美国、67214
        • Via Christi Cancer Center at Via Christi Regional Medical Center
      • Winfield、Kansas、美国、67156
        • Cancer Center of Kansas, PA - Winfield
    • Kentucky
      • Lexington、Kentucky、美国、40536-0293
        • Markey Cancer Center at University of Kentucky Chandler Medical Center
    • Michigan
      • Ann Arbor、Michigan、美国、48109-0942
        • University of Michigan Comprehensive Cancer Center
      • Battle Creek、Michigan、美国、49017
        • Battle Creek Health System Cancer Care Center
      • Big Rapids、Michigan、美国、49307
        • Mecosta County Medical Center
      • Detroit、Michigan、美国、48202
        • Josephine Ford Cancer Center at Henry Ford Hospital
      • Grand Rapids、Michigan、美国、49503
        • CCOP - Grand Rapids
      • Grand Rapids、Michigan、美国、49503
        • Lacks Cancer Center at Saint Mary's Health Care
      • Grand Rapids、Michigan、美国、49506
        • Metro Health Hospital
      • Grand Rapids、Michigan、美国、49503
        • Spectrum Health Hospital - Butterworth Campus
      • Holland、Michigan、美国、49423
        • Holland Community Hospital
      • Muskegon、Michigan、美国、49442
        • Hackley Hospital
      • Traverse City、Michigan、美国、49684
        • Munson Medical Center
    • Missouri
      • Kansas City、Missouri、美国、64131
        • CCOP - Kansas City
      • Saint Louis、Missouri、美国、63110
        • Saint Louis University Cancer Center
      • Springfield、Missouri、美国、65802
        • CCOP - Cancer Research for the Ozarks
      • Springfield、Missouri、美国、65804
        • St. John's Regional Health Center
      • Springfield、Missouri、美国、65807
        • Hulston Cancer Center at Cox Medical Center South
    • Montana
      • Billings、Montana、美国、59101
        • CCOP - Montana Cancer Consortium
      • Billings、Montana、美国、59101
        • Hematology-Oncology Centers of the Northern Rockies - Billings
      • Billings、Montana、美国、59101
        • Northern Rockies Radiation Oncology Center
      • Billings、Montana、美国、59101
        • St. Vincent Healthcare Cancer Care Services
      • Billings、Montana、美国、59107-7000
        • Billings Clinic - Downtown
      • Bozeman、Montana、美国、59715
        • Bozeman Deaconess Cancer Center
      • Butte、Montana、美国、59701
        • St. James Healthcare Cancer Care
      • Great Falls、Montana、美国、59405
        • Great Falls Clinic - Main Facility
      • Great Falls、Montana、美国、59405
      • Helena、Montana、美国、59601
        • St. Peter's Hospital
      • Kalispell、Montana、美国、59901
        • Kalispell Regional Medical Center
      • Kalispell、Montana、美国、59901
        • Glacier Oncology, PLLC
      • Kalispell、Montana、美国、59901
        • Kalispell Medical Oncology at KRMC
      • Missoula、Montana、美国、59801
        • Community Medical Center
      • Missoula、Montana、美国、59804
        • Guardian Oncology and Center for Wellness
      • Missoula、Montana、美国、59807-7877
        • Montana Cancer Specialists at Montana Cancer Center
      • Missoula、Montana、美国、59807
        • Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
    • Nebraska
      • Kearney、Nebraska、美国、68848-1990
        • Good Samaritan Cancer Center at Good Samaritan Hospital
    • New York
      • Rochester、New York、美国、14642
        • James P. Wilmot Cancer Center at University of Rochester Medical Center
      • Rochester、New York、美国、14623
        • Interlakes Oncology/Hematology PC
    • North Carolina
      • Goldsboro、North Carolina、美国、27534
        • Wayne Memorial Hospital, Incorporated
    • Ohio
      • Akron、Ohio、美国、44307
        • McDowell Cancer Center at Akron General Medical Center
      • Dayton、Ohio、美国、45428
        • Veterans Affairs Medical Center - Dayton
      • Dayton、Ohio、美国、45405
        • Grandview Hospital
      • Dayton、Ohio、美国、45406
        • Good Samaritan Hospital
      • Dayton、Ohio、美国、45409
        • David L. Rike Cancer Center at Miami Valley Hospital
      • Dayton、Ohio、美国、45415
        • Samaritan North Cancer Care Center
      • Dayton、Ohio、美国、45429
        • CCOP - Dayton
      • Findlay、Ohio、美国、45840
        • Blanchard Valley Medical Associates
      • Kettering、Ohio、美国、45429
        • Charles F. Kettering Memorial Hospital
      • Middletown、Ohio、美国、45044
        • Middletown Regional Hospital
      • Troy、Ohio、美国、45373-1300
        • UVMC Cancer Care Center at Upper Valley Medical Center
      • Xenia、Ohio、美国、45385
        • Ruth G. McMillan Cancer Center at Greene Memorial Hospital
    • Oregon
      • Gresham、Oregon、美国、97030
        • Legacy Mount Hood Medical Center
      • Milwaukie、Oregon、美国、97222
        • Providence Milwaukie Hospital
      • Portland、Oregon、美国、97227
        • Northwest Cancer Specialists at Rose Quarter Cancer Center
      • Portland、Oregon、美国、97213-2967
        • Providence Cancer Center at Providence Portland Medical Center
      • Portland、Oregon、美国、97225
        • CCOP - Columbia River Oncology Program
      • Portland、Oregon、美国、97225
        • Providence St. Vincent Medical Center
      • Portland、Oregon、美国、97210
        • Legacy Good Samaritan Hospital & Medical Center Comprehensive Cancer Center
      • Portland、Oregon、美国、97227
        • Legacy Emanuel Hospital and Health Center & Children's Hospital
      • Portland、Oregon、美国、97239-3098
        • Oregon Health & Science University Cancer Institute
      • Salem、Oregon、美国、97309-5014
        • Salem Hospital Regional Cancer Care Services
      • Tualatin、Oregon、美国、97062
        • Legacy Meridian Park Hospital
    • South Carolina
      • Charleston、South Carolina、美国、29425
        • Hollings Cancer Center at Medical University of South Carolina
      • Charleston、South Carolina、美国、29401
        • Roper St. Francis Cancer Center at Roper Hospital
      • Greenville、South Carolina、美国、29615
        • CCOP - Greenville
    • Tennessee
      • Kingsport、Tennessee、美国、37662
        • Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center
      • Knoxville、Tennessee、美国、37920-6999
        • U.T. Cancer Institute at University of Tennessee Medical Center
    • Virginia
      • Danville、Virginia、美国、24541
        • Danville Regional Medical Center
      • Norton、Virginia、美国、24273
        • Southwest Virginia Regional Cancer Center
    • Washington
      • Bellingham、Washington、美国、98225
        • St. Joseph Cancer Center
      • Bremerton、Washington、美国、98310
        • Olympic Hematology and Oncology
      • Kennewick、Washington、美国、99336
        • Columbia Basin Hematology
      • Mt. Vernon、Washington、美国、98273
        • Skagit Valley Hospital Cancer Care Center
      • Seattle、Washington、美国、98104
        • Harborview Medical Center
      • Seattle、Washington、美国、98104
        • Fred Hutchinson Cancer Research Center
      • Seattle、Washington、美国、98104
        • Minor and James Medical, PLLC
      • Seattle、Washington、美国、98112
        • Group Health Central Hospital
      • Seattle、Washington、美国、98122-4307
        • Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
      • Seattle、Washington、美国、98122
        • Polyclinic First Hill
      • Seattle、Washington、美国、98195-6043
        • University Cancer Center at University of Washington Medical Center
      • Spokane、Washington、美国、99202
        • Cancer Care Northwest - Spokane South
      • Vancouver、Washington、美国、98684
        • Northwest Cancer Specialists at Vancouver Cancer Center
      • Vancouver、Washington、美国、98668
        • Southwest Washington Medical Center Cancer Center
      • Wenatchee、Washington、美国、98801-2028
        • Wenatchee Valley Medical Center
    • Wyoming
      • Sheridan、Wyoming、美国、82801
        • Welch Cancer Center at Sheridan Memorial Hospital

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：不适用
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Treatment
Cetuximab+Cisplatin+Irinotecan followed by radiation therapy (RT) in Cycle 3.
生物：cetuximab
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.
其他名称：
  • 爱必妥
药品：cisplatin
30mg/m^2, bolus intravenous (IV), on Days 1 & 8 of each cycle.
其他名称：
  • 铂醇
药品：irinotecan hydrochloride
65mg/m^2, intravenous (IV) over 30 min, on Days 1 & 8 of each cycle.
其他名称：
  • CPT-11
辐射：radiation therapy
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.
其他名称：
  • 转播
  • 同仁堂

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Overall Survival at 2 Years
大体时间：0-2 years
Measured from time of registration to date of death due to any cause, or last contact date
0-2 years

次要结果测量

结果测量
措施说明
大体时间
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
大体时间：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)
大体时间：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
大体时间：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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Southwest Oncology Group

合作者

National Cancer Institute (NCI)

调查人员

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

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2005年5月1日

初级完成 (实际的)

2009年9月1日

研究完成 (实际的)

2012年5月1日

研究注册日期

首次提交

2005年5月3日

首先提交符合 QC 标准的

2005年5月3日

首次发布 (估计)

2005年5月4日

研究记录更新

最后更新发布 (估计)

2015年11月18日

上次提交的符合 QC 标准的更新

2015年11月16日

最后验证

2015年11月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • CDR0000426442
  • U10CA032102 (美国 NIH 拨款/合同)
  • S0414 (其他标识符：SWOG)

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

cetuximab的临床试验

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赞助者和合作者

医疗条件

药物干预

CROs by country

CROs in Finland

条件

罕见疾病

药物干预

膳食补充剂

赞助者/合作者

地点

3
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