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Could a smart antibody boost chemo for head and neck cancer?

NCT ID NCT00003809

Disease control Sponsor: Eastern Cooperative Oncology Group Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 3 trial tested whether adding a targeted antibody (cetuximab) to standard chemotherapy (cisplatin) helps people with advanced head and neck cancer that has spread or come back. About 120 patients received either cisplatin plus cetuximab or cisplatin plus a placebo. The goal was to see if the combination improves survival or slows tumor growth.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
cetuximab (C225) and cisplatin
What this could lead to
If successful, this could lead to a new standard treatment that improves survival for people with advanced head and neck cancer.
What could go wrong
This is a completed phase 3 trial, but results may not show a significant benefit over standard chemotherapy. Side effects from both drugs can be serious.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Started

Aug 1999

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 120 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

DISEASE CHARACTERISTICS: Histologically proven squamous cell carcinoma of the head and neck that is incurable with surgery or radiotherapy No nasopharyngeal primaries Measurable or evaluable disease Newly diagnosed with extensive, incurable local regional disease AND distant metastases OR Local regional recurrence/persistence or distant metastases after surgery or radiotherapy Persistent or progressive disease after radiotherapy must be histologically proven at least 8 weeks after therapy No brain metastases PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 10 g/dL (transfusion allowed) Hepatic: Bilirubin no greater than 1.5 mg/dL SGOT and SGPT no greater than 2 times upper limit of normal (ULN) Alkaline phosphatase no greater than 2 times ULN Renal: Creatinine no greater than 1.2 mg/dL OR Creatinine clearance at least 50 mL/min Calcium no greater than ULN No history of hypercalcemia Other: No active infection No other concurrent malignancy within past 2 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix No known hypersensitivity to murine proteins Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: No prior chimeric antibody or kinase inhibitor for recurrent or metastatic disease No more than 1 prior biotherapy regimen for recurrent or metastatic disease Chemotherapy: At least 3 months since prior induction or adjuvant chemotherapy concurrent with radiotherapy No prior chemotherapy for recurrent disease Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics At least 4 weeks since prior radiotherapy Surgery: See Disease Characteristics Recovered from prior major surgery

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Conditions

The condition(s) this trial relates to.

head and neck cancer Head and Neck Neoplasms head and neck squamous cell carcinoma Squamous Cell Carcinoma of Head and Neck

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Head and neck cancer

Contacts and locations

Locations

  • Albert Einstein Comprehensive Cancer Center

    The Bronx, New York, 10461, United States

  • Beckman Research Institute, City of Hope

    Los Angeles, California, 91010, United States

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215, United States

  • CCOP - Ann Arbor Regional

    Ann Arbor, Michigan, 48106, United States

  • CCOP - Carle Cancer Center

    Urbana, Illinois, 61801, United States

  • CCOP - Cedar Rapids Oncology Project

    Cedar Rapids, Iowa, 52403-1206, United States

  • CCOP - Central Illinois

    Decatur, Illinois, 62526, United States

  • CCOP - Christiana Care Health Services

    Wilmington, Delaware, 19899, United States

  • CCOP - Colorado Cancer Research Program, Inc.

    Denver, Colorado, 80209-5031, United States

  • CCOP - Columbus

    Columbus, Ohio, 43206, United States

  • CCOP - Duluth

    Duluth, Minnesota, 55805, United States

  • CCOP - Evanston

    Evanston, Illinois, 60201, United States

  • CCOP - Geisinger Clinic and Medical Center

    Danville, Pennsylvania, 17822-2001, United States

  • CCOP - Illinois Oncology Research Association

    Peoria, Illinois, 61602, United States

  • CCOP - Iowa Oncology Research Association

    Des Moines, Iowa, 50309-1016, United States

  • CCOP - Kalamazoo

    Kalamazoo, Michigan, 49007-3731, United States

  • CCOP - MainLine Health

    Wynnewood, Pennsylvania, 19096, United States

  • CCOP - Marshfield Medical Research and Education Foundation

    Marshfield, Wisconsin, 54449, United States

  • CCOP - Merit Care Hospital

    Fargo, North Dakota, 58122, United States

  • CCOP - Metro-Minnesota

    Saint Louis Park, Minnesota, 55416, United States

  • CCOP - Missouri Valley Cancer Consortium

    Omaha, Nebraska, 68131, United States

  • CCOP - Northern New Jersey

    Hackensack, New Jersey, 07601, United States

  • CCOP - Ochsner

    New Orleans, Louisiana, 70121, United States

  • CCOP - Scottsdale Oncology Program

    Scottsdale, Arizona, 85259-5404, United States

  • CCOP - Sioux Community Cancer Consortium

    Sioux Falls, South Dakota, 57105-1080, United States

  • CCOP - Sooner State

    Tulsa, Oklahoma, 74136, United States

  • CCOP - Southern Nevada Cancer Research Foundation

    Las Vegas, Nevada, 89106, United States

  • CCOP - Toledo Community Hospital Oncology Program

    Toledo, Ohio, 43623-3456, United States

  • CCOP - Wichita

    Wichita, Kansas, 67214-3882, United States

  • Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08901, United States

  • Emory University Hospital - Atlanta

    Atlanta, Georgia, 30322, United States

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111, United States

  • H. Lee Moffitt Cancer Center and Research Institute

    Tampa, Florida, 33612, United States

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601, United States

  • Hahnemann University Hospital

    Philadelphia, Pennsylvania, 19102-1192, United States

  • Indiana University Cancer Center

    Indianapolis, Indiana, 46202-5265, United States

  • Ireland Cancer Center

    Cleveland, Ohio, 44106-5065, United States

  • Johns Hopkins Oncology Center

    Baltimore, Maryland, 21231, United States

  • Kimmel Cancer Center of Thomas Jefferson University - Philadelphia

    Philadelphia, Pennsylvania, 19107, United States

  • MBCCOP - LSU Medical Center

    New Orleans, Louisiana, 70112, United States

  • MBCCOP - San Juan

    San Juan, 00927-5800, Puerto Rico

  • Mayo Clinic Cancer Center

    Rochester, Minnesota, 55905, United States

  • Mayo Clinic Scottsdale

    Scottsdale, Arizona, 85259, United States

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226, United States

  • NYU School of Medicine's Kaplan Comprehensive Cancer Center

    New York, New York, 10016, United States

  • New England Medical Center Hospital

    Boston, Massachusetts, 02111, United States

  • Penn State Geisinger Cancer Center

    Hershey, Pennsylvania, 17033, United States

  • Pretoria Academic Hospitals

    Pretoria, 0001, South Africa

  • Riverview Medical Center

    Red Bank, New Jersey, 07701, United States

  • Robert H. Lurie Comprehensive Cancer Center, Northwestern University

    Chicago, Illinois, 60611, United States

  • St. Francis Medical Center

    Trenton, New Jersey, 08629, United States

  • Stanford University Medical Center

    Stanford, California, 94305-5408, United States

  • Sylvester Cancer Center, University of Miami

    Miami, Florida, 33136, United States

  • University of Pennsylvania Cancer Center

    Philadelphia, Pennsylvania, 19104, United States

  • University of Pittsburgh Cancer Institute

    Pittsburgh, Pennsylvania, 15213, United States

  • University of Rochester Cancer Center

    Rochester, New York, 14642, United States

  • University of Wisconsin Comprehensive Cancer Center

    Madison, Wisconsin, 53792, United States

  • Vanderbilt-Ingram Cancer Center

    Nashville, Tennessee, 37232-6838, United States

  • Veterans Affairs Medical Center - Albany

    Albany, New York, 12208, United States

  • Veterans Affairs Medical Center - Atlanta (Decatur)

    Decatur, Georgia, 30033, United States

  • Veterans Affairs Medical Center - Brooklyn

    Brooklyn, New York, 11209, United States

  • Veterans Affairs Medical Center - Cleveland

    Cleveland, Ohio, 44106, United States

  • Veterans Affairs Medical Center - Gainsville

    Gainesville, Florida, 32608-1197, United States

  • Veterans Affairs Medical Center - Indianapolis (Roudebush)

    Indianapolis, Indiana, 46202, United States

  • Veterans Affairs Medical Center - Lakeside Chicago

    Chicago, Illinois, 60611, United States

  • Veterans Affairs Medical Center - Madison

    Madison, Wisconsin, 53705, United States

  • Veterans Affairs Medical Center - Milwaukee (Zablocki)

    Milwaukee, Wisconsin, 53295, United States

  • Veterans Affairs Medical Center - Minneapolis

    Minneapolis, Minnesota, 55417, United States

  • Veterans Affairs Medical Center - Nashville

    Nashville, Tennessee, 37212, United States

  • Veterans Affairs Medical Center - New York

    New York, New York, 10010, United States

  • Veterans Affairs Medical Center - Palo Alto

    Palo Alto, California, 94304, United States

  • Veterans Affairs Medical Center - Pittsburgh

    Pittsburgh, Pennsylvania, 15240, United States

  • Veterans Affairs Medical Center - San Juan

    San Juan, 00927-5800, Puerto Rico

  • Veterans Affairs Medical Center - Tampa (Haley)

    Tampa, Florida, 33612, United States

  • Walter Reed Army Medical Center

    Washington D.C., District of Columbia, 20307-5000, United States

  • Yale Comprehensive Cancer Center

    New Haven, Connecticut, 06520-8028, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.