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


Phase 2
18 Years
N/A
Not Enrolling
Both
Esophageal Cancer

Thank you

Trial Information

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


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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall Survival at 2 Years

Outcome Description:

Measured from time of registration to date of death due to any cause, or last contact date

Outcome Time Frame:

0-2 years

Safety Issue:

No

Principal Investigator

Charles R. Thomas, MD

Investigator Role:

Study Chair

Investigator Affiliation:

OHSU Knight Cancer Institute

Authority:

United States: Federal Government

Study ID:

CDR0000426442

NCT ID:

NCT00109850

Start Date:

May 2005

Completion Date:

May 2012

Related Keywords:

  • Esophageal Cancer
  • adenocarcinoma of the esophagus
  • squamous cell carcinoma of the esophagus
  • stage III esophageal cancer
  • Esophageal Diseases
  • Esophageal Neoplasms

Name

Location

Fred Hutchinson Cancer Research CenterSeattle, Washington  98109
University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752
CCOP - WichitaWichita, Kansas  67214-3882
CCOP - Kansas CityKansas City, Missouri  64131
Providence Saint Joseph Medical Center - BurbankBurbank, California  91505
CCOP - Bay Area Tumor InstituteOakland, California  94609-3305
CCOP - Santa Rosa Memorial HospitalSanta Rosa, California  95403
CCOP - Cancer Research for the OzarksSpringfield, Missouri  65807
CCOP - Montana Cancer ConsortiumBillings, Montana  59101
Veterans Affairs Medical Center - DaytonDayton, Ohio  45428
CCOP - DaytonKettering, Ohio  45429
CCOP - GreenvilleGreenville, South Carolina  29615
CCOP - Grand RapidsGrand Rapids, Michigan  49503
CCOP - Columbia River Oncology ProgramPortland, Oregon  97225
USC/Norris Comprehensive Cancer Center and HospitalLos Angeles, California  90033-0804
University of California Davis Cancer CenterSacramento, California  95817
Wesley Medical CenterWichita, Kansas  67214
Mobile Infirmary Medical CenterMobile, Alabama  36640-0460
Arkansas Cancer Research Center at University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
Kansas Masonic Cancer Research Institute at the University of Kansas Medical CenterKansas City, Kansas  66160-7353
Markey Cancer Center at University of Kentucky Chandler Medical CenterLexington, Kentucky  40536-0084
Josephine Ford Cancer Center at Henry Ford HospitalDetroit, Michigan  48202
Swedish Cancer Institute at Swedish Medical Center - First Hill CampusSeattle, Washington  98104
Hulston Cancer Center at Cox Medical Center SouthSpringfield, Missouri  65807
St. John's Regional Health CenterSpringfield, Missouri  65804
McDowell Cancer Center at Akron General Medical CenterAkron, Ohio  44307
Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical CenterSavannah, Georgia  31403-3089
St. Luke's Mountain States Tumor Institute - BoiseBoise, Idaho  83712-6297
Via Christi Cancer Center at Via Christi Regional Medical CenterWichita, Kansas  67214
Legacy Emanuel Hospital and Health Center & Children's HospitalPortland, Oregon  97227
Hollings Cancer Center at Medical University of South CarolinaCharleston, South Carolina  29425
Interlakes Oncology/Hematology PCRochester, New York  14623
James P. Wilmot Cancer Center at University of Rochester Medical CenterRochester, New York  14642
Southwest Medical CenterLiberal, Kansas  67901
Battle Creek Health System Cancer Care CenterBattle Creek, Michigan  49017
Holland Community HospitalHolland, Michigan  49423
Hackley HospitalMuskegon, Michigan  49443
Munson Medical CenterTraverse City, Michigan  49684
Northern Rockies Radiation Oncology CenterBillings, Montana  59101
Hematology-Oncology Centers of the Northern Rockies - BillingsBillings, Montana  59101
St. Peter's HospitalHelena, Montana  59601
Kalispell Regional Medical CenterKalispell, Montana  59901
Glacier Oncology, PLLCKalispell, Montana  59901
Montana Cancer Center at St. Patrick Hospital and Health Sciences CenterMissoula, Montana  59802
Montana Cancer Specialists at Montana Cancer CenterMissoula, Montana  59802
Community Medical CenterMissoula, Montana  59801
Wayne Memorial Hospital, IncorporatedGoldsboro, North Carolina  27534
Olympic Hematology and OncologyBremerton, Washington  98310
Skagit Valley Hospital Cancer Care CenterMt. Vernon, Washington  98273
University Cancer Center at University of Washington Medical CenterSeattle, Washington  98195
Harborview Medical CenterSeattle, Washington  98104
Group Health Central HospitalSeattle, Washington  98104
Cancer Care Northwest - Spokane SouthSpokane, Washington  99202
Spectrum Health Hospital - Butterworth CampusGrand Rapids, Michigan  49503
Alta Bates Comprehensive Cancer CenterBerkeley, California  94704
Peninsula Medical CenterBurlingame, California  94010
Eden Medical CenterCastro Valley, California  94546
Sutter Health - Western Division Cancer Research GroupGreenbrae, California  94904
Marin Cancer Institute at Marin General HospitalGreenbrae, California  94904
Saint Rose HospitalHayward, California  94545
Alta Bates Summit Medical Center - Summit CampusOakland, California  94609
Valley Care Medical CenterPleasanton, California  94588
California Pacific Medical Center - California CampusSan Francisco, California  94118
Sutter Solano Medical CenterVallejo, California  94589
Poudre Valley HospitalFort Collins, Colorado  80524
St. Francis Hospital and Health Centers - Beech Grove CampusBeech Grove, Indiana  46107
Reid Hospital & Health Care Services, IncorporatedRichmond, Indiana  47374
Cancer Center of Kansas, PA - Dodge CityDodge City, Kansas  67801
Mecosta County Medical CenterBig Rapids, Michigan  49307
Samaritan North Cancer Care CenterDayton, Ohio  45415
Grandview HospitalDayton, Ohio  45405
David L. Rike Cancer Center at Miami Valley HospitalDayton, Ohio  45409
Good Samaritan HospitalDayton, Ohio  45406
Blanchard Valley Medical AssociatesFindlay, Ohio  45840
Charles F. Kettering Memorial HospitalKettering, Ohio  45429
Middletown Regional HospitalMiddletown, Ohio  45044
UVMC Cancer Care Center at Upper Valley Medical CenterTroy, Ohio  45373-1300
Ruth G. McMillan Cancer Center at Greene Memorial HospitalXenia, Ohio  45385
Legacy Mount Hood Medical CenterGresham, Oregon  97030
Providence Milwaukie HospitalMilwaukie, Oregon  97222
Legacy Good Samaritan Hospital & Medical Center Comprehensive Cancer CenterPortland, Oregon  97210
Providence Cancer Center at Providence Portland Medical CenterPortland, Oregon  97213-2967
Providence St. Vincent Medical CenterPortland, Oregon  97225
Legacy Meridian Park HospitalTualatin, Oregon  97062
Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical CenterKingsport, Tennessee  37662
Danville Regional Medical CenterDanville, Virginia  24541
Southwest Virginia Regional Cancer CenterNorton, Virginia  24273
Minor and James Medical, PLLCSeattle, Washington  98104
Polyclinic First HillSeattle, Washington  98122
Southwest Washington Medical Center Cancer CenterVancouver, Washington  98668
Welch Cancer Center at Sheridan Memorial HospitalSheridan, Wyoming  82801
Highland General HospitalOakland, California  94602
Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/CandlerSavannah, Georgia  31405
Cancer Center of Kansas, PA - ChanuteChanute, Kansas  66720
Cancer Center of Kansas, PA - El DoradoEl Dorado, Kansas  67042
Cancer Center of Kansas, PA - KingmanKingman, Kansas  67068
Cancer Center of Kansas, PA - NewtonNewton, Kansas  67114
Cancer Center of Kansas, PA - ParsonsParsons, Kansas  67357
Cancer Center of Kansas, PA - PrattPratt, Kansas  67124
Tammy Walker Cancer Center at Salina Regional Health CenterSalina, Kansas  67401
Cancer Center of Kansas, PA - SalinaSalina, Kansas  67401
Cancer Center of Kansas, PA - WellingtonWellington, Kansas  67152
Cancer Center of Kansas, PA - WichitaWichita, Kansas  67214
Associates in Womens Health, PA - North ReviewWichita, Kansas  67208
Cancer Center of Kansas, PA - Medical Arts TowerWichita, Kansas  67208
Cancer Center of Kansas, PA - WinfieldWinfield, Kansas  67156
Billings Clinic - DowntownBillings, Montana  59107-7000
Bozeman Deaconess Cancer CenterBozeman, Montana  59715
St. James Healthcare Cancer CareButte, Montana  59701
Great Falls Clinic - Main FacilityGreat Falls, Montana  59405
Kalispell Medical Oncology at KRMCKalispell, Montana  59901
Northwest Cancer Specialists at Rose Quarter Cancer CenterPortland, Oregon  97227
Salem Hospital Regional Cancer Care ServicesSalem, Oregon  97309-5014
St. Joseph Cancer CenterBellingham, Washington  98225
Columbia Basin HematologyKennewick, Washington  99336
Wenatchee Valley Medical CenterWenatchee, Washington  98801-2028
Oregon Health & Science University Cancer InstitutePortland, Oregon  97239-3098
Regional Cancer Center at Memorial Medical CenterSpringfield, Illinois  62781-0001
Saint Louis University Cancer CenterSaint Louis, Missouri  63110
Good Samaritan Cancer Center at Good Samaritan HospitalKearney, Nebraska  68848-1990
U.T. Cancer Institute at University of Tennessee Medical CenterKnoxville, Tennessee  37920-2911
Lacks Cancer Center at Saint Mary's Health CareGrand Rapids, Michigan  49503
Metro Health HospitalGrand Rapids, Michigan  49506
Great Falls, Montana  59405
Guardian Oncology and Center for WellnessMissoula, Montana  59804
Roper St. Francis Cancer Center at Roper HospitalCharleston, South Carolina  29401
Doctors Medical Center - San Pablo CampusSan Pablo, California  94806
St. Vincent Healthcare Cancer Care ServicesBillings, Montana  59101
Desert Regional Medical Center Comprehensive Cancer CenterPalm Springs, California  92262
Watson Clinic, LLCLakeland, Florida  33804-5000
Augusta Oncology Associates - Walton WayAugusta, Georgia  30901
Northwest Cancer Specialists at Vancouver Cancer CenterVancouver, Washington  98684