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

Completed · Phase 2

Conditions studied: Head and Neck, Squamous Cell Cancer

In brief

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.

Key facts

Study ID

NCT00661427

Run by

Memorial Sloan Kettering Cancer Center

People needed

61

Starts

2007-11-01

Expected to finish

2012-08-01

Last updated by the study team

2018-01-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• City of Hope National Medical Center — Duarte, California, United States
• H. Lee Moffit Cancer Center and Research Institute — Tampa, Florida, United States
• NorthShore University Health System — Evanston, Illinois, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• University of Nebraska Medical Center — Omaha, Nebraska, United States
• Memorial Sloan-Kettering Cancer Center at Basking Ridge — Basking Ridge, New Jersey, United States
• Memorial Sloan-Kettering Cancer Center at Commack — Commack, New York, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Memorial Sloan-Kettering at Mercy Medical Center — Rockville Centre, New York, United States
• Memoral Sloan Kettering Cancer Center@Phelps — Sleepy Hollow, New York, United States
• Fox Chase Virtua Health Cancer Program — Philadelphia, Pennsylvania, United States
• University of Pennsylvania - Abramson Cancer Center — Philadelphia, Pennsylvania, United States
• Abramson Cancer Center University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Pennsylvania Hospital — Philadelphia, Pennsylvania, United States
• Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States
• University of Tennessee Cancer Institute — Memphis, Tennessee, United States
• Huntsman Cancer Institue — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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