Clinical trial NCT00661427: Cetuximab at Either 500 or 750 mg/m2 Every Other Week for Recurrent or Metastatic Head and Neck Squamous Cell Cancer
Official title: A Phase II Randomized Study of Cetuximab at Either 500 or 750 mg/m^2 Every Other Week for Recurrent or Metastatic Head and Neck Squamous Cell Cancer.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Head and Neck
Squamous Cell Cancer
Keywords: Head and Neck cancer
Cetuximab
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: Eli Lilly and Company
name: National Comprehensive Cancer Network
First posted: 2008-04-18
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Patients With Overall Objective Response
timeFrame: Approximately every 8 weeks with imaging up to two years
Secondary outcomes:
measure: The Total Number of Participants That Were Effected by Adverse Events.
timeFrame: at least weekly
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope National Medical Center
state: California
city: Tampa
country: United States
facility: H. Lee Moffit Cancer Center and Research Institute
state: Florida
city: Evanston
country: United States
facility: NorthShore University Health System
state: Illinois
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: Basking Ridge
country: United States
facility: Memorial Sloan-Kettering Cancer Center at Basking Ridge
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan-Kettering Cancer Center at Commack
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Rockville Centre
country: United States
facility: Memorial Sloan-Kettering at Mercy Medical Center
state: New York
city: Sleepy Hollow
country: United States
facility: Memoral Sloan Kettering Cancer Center@Phelps
state: New York
city: Philadelphia
country: United States
facility: Fox Chase Virtua Health Cancer Program
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania - Abramson Cancer Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Abramson Cancer Center University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Pennsylvania Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
city: Memphis
country: United States
facility: University of Tennessee Cancer Institute
state: Tennessee
city: Salt Lake City
country: United States
facility: Huntsman Cancer Institue
state: Utah
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Matthew Fury, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: