Cetuximab at Either 500 or 750 mg/m2 Every Other Week for Recurrent or Metastatic Head and Neck Squamous Cell Cancer

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2012-08-31

Brief Summary

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The purpose of this study is to find out what effects, good and/or bad, 2 doses of Cetuximab will have on head and neck cancer. The study is done because 250 mg/m2 given weekly does not work very well. Doses as high as 700 mg/m2 every other week appear to be no more toxic, so we will try to determine if 500 mg/m2 and 750 mg/m2 given every other week can work better. We do not know if it will help. We can use what we learn from this research study to help other people with the same disease.

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Detailed Description

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Conditions

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Head and Neck Squamous Cell Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cetuximab 500 mg/m^2

Cetuximab 500 mg/m\^2 IV over 2 hours every other week

Group Type ACTIVE_COMPARATOR

cetuximab

Intervention Type BIOLOGICAL

Cetuximab 500 mg/m\^2 IV over 2 hours every other week

Cetuximab 750 mg/m^2

Cetuximab 750 mg/m\^2 IV over 3 hours every other week

Group Type ACTIVE_COMPARATOR

cetuximab

Intervention Type BIOLOGICAL

Cetuximab 750 mg/m\^2 IV over 3 hours every other week

Interventions

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cetuximab

Cetuximab 500 mg/m\^2 IV over 2 hours every other week

Intervention Type BIOLOGICAL

cetuximab

Cetuximab 750 mg/m\^2 IV over 3 hours every other week

Intervention Type BIOLOGICAL

Other Intervention Names

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Erbitux Erbitux

Eligibility Criteria

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Inclusion Criteria

* signed informed consent and HIPAA authorization
* histologically confirmed squamous cell cancer of the head and neck
* At least 21 days must have elapsed from the administration of prior chemotherapy for recurrent/metastatic disease.
* measurable disease as defined by RECIST
* ECOG PS ≤ 2
* Adequate hematologic function as defined by an ANC \> or = to 1200/mm3 , and a platelet count ≥ 100,000 obtained within 14 days prior to enrollment.
* Adequate hepatic function as defined by t. bilirubin ≤ 1.5 mg/dl, transaminases \& alk phos ≤ 5x ULN obtained within 14 days prior to enrollment.
* Adequate renal function as defined by serum creatinine ≤ 1.5 x ULN or creatinine clearance \>40 mL/minute.
* Women of childbearing potential must agree to use an accepted and effective method of contraception (hormonal or barrier methods, abstinence) prior to study entry and for the duration of the study and have a negative pregnancy test within 7 days prior to registration. If a male and sexually active, the patient agrees to use effective contraception.
* Accessible for treatment and follow-up. Patients enrolled in this trial must be treated at the participating center.
* Patients with treated CNS metastases may be eligible if they have fully recovered from radiation therapy, surgery or steroids that were prescribed for CNS metastases.

Exclusion Criteria

* Known, uncontrolled CNS metastases. CT/MRI of the brain is not required unless CNS metastases are suspected clinically.
* prior cetuximab therapy in the setting of recurrence or refractory disease
* Other active invasive malignancies, other than non-melanoma skin cancers or in situ cervical cancer.
* Concurrent treatment with other anti-cancer therapy, including other chemotherapy, immunotherapy, hormonal therapy, radiotherapy, chemo-embolization, or targeted therapy.
* Ongoing or active clinically serious infection \> CTCAE Grade 2 requiring IV antibiotics, symptomatic congestive heart failure, unstable angina pectoris, unstable cardiac arrhythmia,(patients with stable rate-controlled atrial fibrillation may be eligible) or other medical condition that, in the opinion of the investigator, would compromise the safety of the patient or compromise the patient's ability to complete the study, or psychiatric illness/social situations that would limit compliance with study requirements.
* elective or planned major surgery to be performed during the course of the trial
* pregnant or lactating women
* employees of the investigator or study center w/ direct involvement in this study or other studies under the direction of the or study center, as well as family member of the employees
* More than two prior cytotoxic regimens for metastatic/recurrent disease.
* Known hypersensitivity reaction to mouse antibodies.
* Patients with nasopharyngeal cancer are excluded.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Matthew Fury, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

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City of Hope National Medical Center

Duarte, California, United States

Site Status

H. Lee Moffit Cancer Center and Research Institute

Tampa, Florida, United States

Site Status

NorthShore University Health System

Evanston, Illinois, United States

Site Status

Washington University School of Medicine

St Louis, Missouri, United States

Site Status

University of Nebraska Medical Center

Omaha, Nebraska, United States

Site Status

Memorial Sloan-Kettering Cancer Center at Basking Ridge

Basking Ridge, New Jersey, United States

Site Status

Memorial Sloan-Kettering Cancer Center at Commack

Commack, New York, United States

Site Status

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Site Status

Memorial Sloan-Kettering at Mercy Medical Center

Rockville Centre, New York, United States

Site Status