Status:
COMPLETED
Cetuximab at Either 500 or 750 mg/m2 Every Other Week for Recurrent or Metastatic Head and Neck Squamous Cell Cancer
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborating Sponsors:
Eli Lilly and Company
National Comprehensive Cancer Network
Conditions:
Head and Neck
Squamous Cell Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT00661427
Start Date
November 1 2007
End Date
August 1 2012
Last Update
January 11 2018
Active Locations (17)
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1
City of Hope National Medical Center
Duarte, California, United States, 91010-3000
2
H. Lee Moffit Cancer Center and Research Institute
Tampa, Florida, United States, 33612
3
NorthShore University Health System
Evanston, Illinois, United States, 60201
4
Washington University School of Medicine
St Louis, Missouri, United States, 63110