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Esophageal CancerPhase 2NCT00096031

S0415 Cetuximab in Treating Patients With Metastatic Esophageal Cancer or Gastroesophageal Junction Cancer

A Phase 2 study testing cetuximab in people with Esophageal Cancer, run by SWOG Cancer Research Network at 152 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

RATIONALE: Biological therapies such as cetuximab may stop the growth of tumor cells by blocking the enzymes necessary for their growth. PURPOSE: This phase II trial is studying how well cetuximab works in treating patients with metastatic esophageal cancer or gastroesophageal junction cancer. Read more about this study

Who is it for?
Ages 18 to 120 years
Conditions the study is for
Esophageal Cancer
What is being tested?
cetuximab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
63 participants
Where
152 sitesUnited States
Study dates
Oct 2004to Jan 2010
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 120 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically confirmed adenocarcinoma of 1 of the following sites:
  • Thoracic esophagus, located > 20 cm* from the incisors
  • Gastroesophageal junction, located ≤ 2 cm into the gastric cardia NOTE: *Tumors located < 26 cm from the incisors must be confirmed by bronchoscopy and negative cytology
  • Disease confined to the esophagus and periesophageal soft tissue
  • Metastatic disease
  • Measurable disease by x-ray, scanning, or physical examination
  • Received exactly 1 prior chemotherapy regimen for metastatic or recurrent disease
  • One prior adjuvant or neoadjuvant chemotherapy regimen allowed if administered at the time of initial diagnosis with localized disease
  • No known brain metastases

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • Zubrod 0-2

Life expectancy

  • Not specified

Hematopoietic

  • Granulocyte count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3

Hepatic

  • Not specified

Renal

  • Creatinine ≤ 1.5 times upper limit of normal

Other

  • No prior allergic reaction to chimerized or murine monoclonal antibodies
  • No evidence of human anti-mouse antibodies (HAMA)
  • 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 in complete remission
  • Not pregnant or nursing
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No prior cetuximab

Chemotherapy

  • See Disease Characteristics
  • At least 4 weeks since prior chemotherapy and recovered
  • No concurrent chemotherapy

Endocrine therapy

  • Not specified

Radiotherapy

  • At least 4 weeks since prior radiotherapy and recovered

Surgery

  • At least 3 weeks since prior thoraco-abdominal surgery and recovered

Other

  • No other prior therapy that specifically targets the epidermal growth factor pathway
  • No other concurrent investigational agents

Trial locations and contacts

152 sites in 1 country.

152 sites in 1 country

United States152 sites

  • Alaska Regional Hospital Cancer Center

    Anchorage, Alaska, 99508

  • AnMed Health Cancer Center

    Anderson, South Carolina, 29621

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109-0942

  • Randolph Hospital

    Asheboro, North Carolina, 27203-5400

  • Mission Hospitals - Memorial Campus

    Asheville, North Carolina, 28801

  • Piedmont Hospital

    Atlanta, Georgia, 30309

  • Northside Hospital Cancer Center

    Atlanta, Georgia, 30342-1611

  • Saint Joseph's Hospital of Atlanta

    Atlanta, Georgia, 30342-1701

  • CCOP - Atlanta Regional

    Atlanta, Georgia, 30342

  • University of Colorado Cancer Center at University of Colorado Health Sciences Center

    Aurora, Colorado, 80045

  • WellStar Cobb Hospital

    Austell, Georgia, 30106

  • Battle Creek Health System Cancer Care Center

    Battle Creek, Michigan, 49017

  • Bay Regional Medical Center

    Bay City, Michigan, 48708

  • St. Francis Hospital and Health Centers - Beech Grove Campus

    Beech Grove, Indiana, 46107

  • St. Joseph Cancer Center

    Bellingham, Washington, 98225

  • Mecosta County Medical Center

    Big Rapids, Michigan, 49307

  • CCOP - Montana Cancer Consortium

    Billings, Montana, 59101

  • Hematology-Oncology Centers of the Northern Rockies - Billings

    Billings, Montana, 59101

  • Northern Rockies Radiation Oncology Center

    Billings, Montana, 59101

  • St. Vincent Healthcare

    Billings, Montana, 59101

  • Deaconess Billings Clinic - Downtown

    Billings, Montana, 59107-7000

  • Cancer Research Center at Boston Medical Center

    Boston, Massachusetts, 02118

  • Bozeman Deaconess Hospital

    Bozeman, Montana, 59715

  • Olympic Hematology and Oncology

    Bremerton, Washington, 98310

  • St. James Community Hospital

    Butte, Montana, 59701

  • Eden Medical Center

    Castro Valley, California, 94546

  • Cancer Center of Kansas, PA - Chanute

    Chanute, Kansas, 66720

  • Hollings Cancer Center at Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Presbyterian Cancer Center at Presbyterian Hospital

    Charlotte, North Carolina, 28233-3549

  • Charles M. Barrett Cancer Center at University Hospital

    Cincinnati, Ohio, 45267

  • Danville Regional Medical Center

    Danville, Virginia, 24541

  • Grandview Hospital

    Dayton, Ohio, 45405

  • Good Samaritan Hospital

    Dayton, Ohio, 45406

  • David L. Rike Cancer Center at Miami Valley Hospital

    Dayton, Ohio, 45409

  • Samaritan North Cancer Care Center

    Dayton, Ohio, 45415

  • Veterans Affairs Medical Center - Dayton

    Dayton, Ohio, 45428

  • CCOP - Dayton

    Dayton, Ohio, 45429

  • Charles B. Eberhart Cancer Center at DeKalb Medical Center

    Decatur, Georgia, 30033

  • Decatur Memorial Hospital Cancer Care Institute

    Decatur, Illinois, 62526

  • Denver Health Medical Center

    Denver, Colorado, 80204

  • Veterans Affairs Medical Center - Denver

    Denver, Colorado, 80220

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48201-1379

  • Josephine Ford Cancer Center at Henry Ford Hospital

    Detroit, Michigan, 48202

  • Cancer Center of Kansas, PA - Dodge City

    Dodge City, Kansas, 67801

  • John Smith, Jr. - Dalton McMichael Cancer Center at Morehead Memorial Hospital

    Eden, North Carolina, 27288

  • Cancer Center of Kansas, PA - El Dorado

    El Dorado, Kansas, 67042

  • Sherman Hospital

    Elgin, Illinois, 60120

  • Blanchard Valley Medical Associates

    Findlay, Ohio, 45840

  • Poudre Valley Hospital

    Fort Collins, Colorado, 80524

  • Brooke Army Medical Center

    Fort Sam Houston, Texas, 78234

  • Northeast Georgia Medical Center

    Gainesville, Georgia, 30501

  • Wayne Memorial Hospital, Incorporated

    Goldsboro, North Carolina, 27534

  • Wayne Radiation Oncology

    Goldsboro, North Carolina, 27534

  • CCOP - Grand Rapids

    Grand Rapids, Michigan, 49503

  • Lacks Cancer Center at Saint Mary's Health Care

    Grand Rapids, Michigan, 49503

  • Spectrum Health Hospital - Butterworth Campus

    Grand Rapids, Michigan, 49503

  • Metro Health Hospital

    Grand Rapids, Michigan, 49506

  • Big Sky Oncology

    Great Falls, Montana, 59405

  • Sletten Regional Cancer Institute at Benefis Healthcare

    Great Falls, Montana, 59405

  • Moses Cone Regional Cancer Center at Wesley Long Community Hospital

    Greensboro, North Carolina, 27403-1198

  • Bon Secours St. Francis Health System

    Greenville, South Carolina, 29601

  • CCOP - Greenville

    Greenville, South Carolina, 29615

  • Legacy Mount Hood Medical Center

    Gresham, Oregon, 97030

  • Saint Rose Hospital

    Hayward, California, 94545

  • St. Peter's Hospital

    Helena, Montana, 59601

  • Holland Community Hospital

    Holland, Michigan, 49423

  • Glacier Oncology, PLLC

    Kalispell, Montana, 59901

  • Kalispell Medical Oncology

    Kalispell, Montana, 59901

  • Veterans Affairs Medical Center - Kansas City

    Kansas City, Kansas, 64128

  • CCOP - Kansas City

    Kansas City, Missouri, 64131

  • Good Samaritan Cancer Center at Good Samaritan Hospital

    Kearney, Nebraska, 68848-1990

  • Charles F. Kettering Memorial Hospital

    Kettering, Ohio, 45429

  • Cancer Center of Kansas, PA - Kingman

    Kingman, Kansas, 67068

  • Wilford Hall Medical Center

    Lackland Air Force Base, Texas, 78236

  • Gwinnett Medical Center

    Lawrenceville, Georgia, 30045

  • Markey Cancer Center at University of Kentucky Chandler Medical Center

    Lexington, Kentucky, 40536-0293

  • Southwest Medical Center

    Liberal, Kansas, 67901

  • Arkansas Cancer Research Center at University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

  • USC/Norris Comprehensive Cancer Center and Hospital

    Los Angeles, California, 90089-9181

  • Kennestone Cancer Center at Wellstar Kennestone Hospital

    Marietta, Georgia, 30060

  • Middletown Regional Hospital

    Middletown, Ohio, 45044

  • Providence Milwaukie Hospital

    Milwaukie, Oregon, 97222

  • Community Medical Center

    Missoula, Montana, 59801

  • Guardian Oncology and Center for Wellness

    Missoula, Montana, 59804

  • Montana Cancer Specialists at Montana Cancer Center

    Missoula, Montana, 59807-7877

  • Montana Cancer Center at St. Patrick Hospital and Health Sciences Center

    Missoula, Montana, 59807

  • Mobile Infirmary Medical Center

    Mobile, Alabama, 36652-2144

  • Montrose Memorial Hospital Cancer Center

    Montrose, Colorado, 81401

  • Skagit Valley Hospital Cancer Care Center

    Mount Vernon, Washington, 98273

  • Hackley Hospital

    Muskegon, Michigan, 49442

  • Cancer Center of Kansas, PA - Newton

    Newton, Kansas, 67114

  • Highland General Hospital at St. George's University School of Medicine

    Oakland, California, 94602

  • Alta Bates Summit Medical Center - Summit Campus

    Oakland, California, 94609

  • CCOP - Bay Area Tumor Institute

    Oakland, California, 94609

  • Cancer Center of Kansas, PA - Parsons

    Parsons, Kansas, 67357

  • Valley Care Medical Center

    Pleasanton, California, 94588

  • St. Joseph Mercy Oakland

    Pontiac, Michigan, 48341-2985

  • Legacy Good Samaritan Hospital & Medical Center Comprehensive Cancer Center

    Portland, Oregon, 97210

  • Providence Cancer Center at Providence Portland Medical Center

    Portland, Oregon, 97213-2967

  • CCOP - Columbia River Oncology Program

    Portland, Oregon, 97225

  • Providence St. Vincent Medical Center

    Portland, Oregon, 97225

  • Legacy Emanuel Hospital and Health Center & Children's Hospital

    Portland, Oregon, 97227

  • Oregon Health & Science University Cancer Institute

    Portland, Oregon, 97239-3098

  • Cancer Center of Kansas, PA - Pratt

    Pratt, Kansas, 67124

  • Annie Penn Cancer Center

    Reidsville, North Carolina, 27320

  • Reid Hospital & Health Care Services, Incorporated

    Richmond, Indiana, 47374

  • Southern Regional Medical Center

    Riverdale, Georgia, 30274-2600

  • Interlakes Oncology/Hematology PC

    Rochester, New York, 14623

  • James P. Wilmot Cancer Center at University of Rochester Medical Center

    Rochester, New York, 14642

  • Rutherford Hospital

    Rutherfordton, North Carolina, 28139

  • University of California Davis Cancer Center

    Sacramento, California, 95817

  • Salem Hospital Regional Cancer Care Services

    Salem, Oregon, 97309-5014

  • Cancer Center of Kansas, PA - Salina

    Salina, Kansas, 67042

  • Doctors Medical Center - San Pablo Campus

    San Pablo, California, 94806

  • Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center

    Savannah, Georgia, 31403-3089

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington, 98104

  • Harborview Medical Center

    Seattle, Washington, 98104

  • Minor and James Medical, PLLC

    Seattle, Washington, 98104

  • Group Health Central Hospital

    Seattle, Washington, 98112

  • Swedish Cancer Institute at Swedish Medical Center - First Hill Campus

    Seattle, Washington, 98122-4307

  • Polyclinic First Hill

    Seattle, Washington, 98122

  • University Cancer Center at University of Washington Medical Center

    Seattle, Washington, 98195-6043

  • North Puget Oncology at United General Hospital

    Sedro-Woolley, Washington, 98284

  • Welch Cancer Center at Sheridan Memorial Hospital

    Sheridan, Wyoming, 82801

  • CCOP - Upstate Carolina

    Spartanburg, South Carolina, 29303

  • Gibbs Regional Cancer Center at Spartanburg Regional Medical Center

    Spartanburg, South Carolina, 29303

  • Cancer Care Northwest - Spokane South

    Spokane, Washington, 99202

  • Regional Cancer Center at Memorial Medical Center

    Springfield, Illinois, 62781-0001

  • CCOP - Cancer Research for the Ozarks

    Springfield, Missouri, 65802

  • St. John's Regional Health Center

    Springfield, Missouri, 65804

  • Hulston Cancer Center at Cox Medical Center South

    Springfield, Missouri, 65807

  • CCOP - Scott and White Hospital

    Temple, Texas, 76508

  • Munson Medical Center

    Traverse City, Michigan, 49684

  • UVMC Cancer Care Center at Upper Valley Medical Center

    Troy, Ohio, 45373-1300

  • Legacy Meridian Park Hospital

    Tualatin, Oregon, 97062

  • Pearlman Comprehensive Cancer Center at South Georgia Medical Center

    Valdosta, Georgia, 31603

  • Southwest Washington Medical Center Cancer Center

    Vancouver, Washington, 98668

  • Cancer Center of Kansas, PA - Wellington

    Wellington, Kansas, 67152

  • Wenatchee Valley Medical Center

    Wenatchee, Washington, 98801-2028

  • Exempla Lutheran Medical Center

    Wheat Ridge, Colorado, 80033

  • Associates in Womens Health, PA - North Review

    Wichita, Kansas, 67203

  • Cancer Center of Kansas, PA - Medical Arts Tower

    Wichita, Kansas, 67208

  • Cancer Center of Kansas, PA - Wichita

    Wichita, Kansas, 67214

  • CCOP - Wichita

    Wichita, Kansas, 67214

  • Via Christi Cancer Center at Via Christi Regional Medical Center

    Wichita, Kansas, 67214

  • Wilson Medical Center

    Wilson, North Carolina, 27893-3428

  • Cancer Center of Kansas, PA - Winfield

    Winfield, Kansas, 67156

  • Forsyth Regional Cancer Center at Forsyth Medical Center

    Winston-Salem, North Carolina, 27103

  • United States Air Force Medical Center - Wright-Patterson

    Wright-Patterson Air Force Base, Ohio, 45433-5529

  • Ruth G. McMillan Cancer Center at Greene Memorial Hospital

    Xenia, Ohio, 45385

  • North Star Lodge Cancer Center at Yakima Valley Memorial Hospital

    Yakima, Washington, 98902

  • Tod Children's Hospital - Forum Health

    Youngstown, Ohio, 44501

Other trials in United States

About this study

Official title: Cetuximab As Second Line Therapy In Patients With Metastatic Esophageal Cancer - Phase II

RATIONALE: Biological therapies such as cetuximab may stop the growth of tumor cells by blocking the enzymes necessary for their growth.

PURPOSE: This phase II trial is studying how well cetuximab works in treating patients with metastatic esophageal cancer or gastroesophageal junction cancer.

Read the detailed description

OBJECTIVES:

  • Determine the 6-month overall survival of patients with metastatic adenocarcinoma of the esophagus or gastroesophageal junction treated with cetuximab as second-line therapy.
  • Determine the response rate (confirmed and unconfirmed, complete and partial), time to progression, and time to treatment failure in patients treated with this drug.
  • Determine the toxicity of this drug in these patients.
  • Correlate, preliminarily, gene expression and germline polymorphism of enzymes and genes involved in the epidermal growth factor receptor pathway, DNA repair, and angiogenesis with time to progression, response, overall survival, toxic effects, and time to treatment failure in patients treated with this drug.

OUTLINE: This is a multicenter study.

Patients receive cetuximab IV over 1-2 hours on day 1. Treatment repeats 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 until 3 years from the date of study registration.

PROJECTED ACCRUAL: A total of 30-55 patients will be accrued for this study within 6-14 months.

Being tested
cetuximab
Keywords
adenocarcinoma of the esophagus, recurrent esophageal cancer, stage IV esophageal cancer
Medical subject headings
Esophageal Neoplasms, Adenocarcinoma Of Esophagus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • cetuximabBiological

    Also called Erbitux

    1 time Cetuximab 400mg/m2 IV over 120 minutes followed by weekly Cetuximab 250mg/m2 IV over 60 minutes.

Study groups in NCT00096031
Study groupRoleWhat they receive
CetuximabExperimental250 mg/m^2 on days 1, 8, 15, and 22 of every 28-day cycle.
Receives: Biological: cetuximab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival at 6 Months

    Time to death is measured from date of registration to date of death due to any cause.

    Measured: every 3 weeks while on treatment, then every 3 months

Secondary outcomes (2)

  1. Time to Treatment Failure

    Time to treatment failure is measured from date of registration to date of first observation of progressive disease, death due to any cause, symptomatic deterioration, or early discontinuation of treatment. Progressive disease is defined as one or more of the following: 20% increase in the sum of longest diameters of target measurable lesions over smallest sum observed (over baseline if no decrease during therapy) using the same techniques as baseline. Unequivocal progression of non-measurable disease in the opinion of the treating physician (an explanation must be provided). Appearance of any new lesion/site. Death due to disease without prior documentation of progression and without symptomatic deterioration. Symptomatic deterioration is defined as global deterioration of health status requiring discontinuation of treatment without objective evidence of progression.

    Measured: every 3 weeks while on treatment

  2. Time to Progression

    Progression free survival is measured from date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression free are censored at date of last contact. Progressive disease is defined as one or more of the following: 20% increase in the sum of longest diameters of target measurable lesions over smallest sum observed (over baseline if no decrease during therapy) using the same techniques as baseline. Unequivocal progression of non-measurable disease in the opinion of the treating physician (an explanation must be provided). Appearance of any new lesion/site. Death due to disease without prior documentation of progression and without symptomatic deterioration. Symptomatic deterioration is defined as global deterioration of health status requiring discontinuation of treatment without objective evidence of progression.

    Measured: every 3 weeks while on treatment, then every 3 months for 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Nov 2004 (estimated)
  2. Study startOct 2004
  3. Primary completionJan 2008
  4. Study completionJan 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
63 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00096031
Sponsor's protocol ID
CDR0000391201
Other IDs
S0415, U10CA032102
Status last verified
Aug 2018
First submitted
9 Nov 2004
Last updated
26 Sep 2018
Data monitoring committee
Yes

Publications

  • Gold PJ, Goldman B, Iqbal S, et al.: Cetuximab as second-line therapy in patients with metastatic esophageal cancer: a phase II Southwest Oncology Group study. [Abstract] American Society of Clinical Oncology 2008 Gastrointestinal Cancers Symposium, 25-27 January 2008, Orlando, FL. A-96, 2008.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing cetuximab in people with Esophageal Cancer, run by SWOG Cancer Research Network at 152 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 152 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 May 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival at 6 Months (time frame: every 3 weeks while on treatment, then every 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00096031, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2018.

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