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A Phase II Randomized Study of Cetuximab at Either 500 or 750 mg/m2 Every Other Week for Recurrent or Metastatic Head and Neck Squamous Cell Cancer.

Phase 2
18 Years
Not Enrolling
Head and Neck, Squamous Cell Cancer

Thank you

Trial Information

A Phase II Randomized Study of Cetuximab at Either 500 or 750 mg/m2 Every Other Week for Recurrent or Metastatic Head and Neck Squamous Cell Cancer.

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

- 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

- 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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Evaluate response rate

Outcome Time Frame:

Approximately every 8 weeks with imaging

Safety Issue:


Principal Investigator

Matthew Fury, MD,PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

November 2007

Completion Date:

August 2012

Related Keywords:

  • Head and Neck
  • Squamous Cell Cancer
  • Head and Neck cancer
  • Cetuximab
  • Carcinoma, Squamous Cell
  • Neoplasms, Squamous Cell



Memorial Sloan Kettering Cancer Center New York, New York  10021
Washington University School of Medicine Saint Louis, Missouri  63110
Fox Chase Cancer Center Philadelphia, Pennsylvania  19111
Pennsylvania Hospital Philadelphia, Pennsylvania  19107
University of Nebraska Medical Center Omaha, Nebraska  68198-3330
University of Tennessee Cancer Institute Memphis, Tennessee  38103
City of Hope National Medical Center Los Angeles, California  91010
Huntsman Cancer Institue Salt Lake City, Utah  84112
Memorial Sloan-Kettering Cancer Center at Basking Ridge Basking Ridge, New Jersey  07920
Memorial Sloan-Kettering Cancer Center at Commack Commack, New York  11725
Memorial Sloan-Kettering at Mercy Medical Center Rockville Centre, New York  
Memoral Sloan Kettering Cancer Center@Phelps Sleepy Hollow, New York  
NorthShore University health system Evanston, Illinois  60201
H. Lee Moffit Cancer Center and Research Institute Tampa, Florida  33612
Fox Chase Virtua Health Cancer Program Philadelphia, Pennsylvania  08060
University of Pennsylvania - Abramson Cancer Center Philadelphia, Pennsylvania  19104-4283
Abramson Cancer Center University of Pennsylvania Philadelphia, Pennsylvania  19104