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

This study has been completed.
Sponsor:
Collaborators:
ImClone LLC
National Comprehensive Cancer Network
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00661427
First received: January 7, 2008
Last updated: August 17, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention Phase
Head and Neck
Squamous Cell Cancer
Biological: cetuximab
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • Evaluate response rate [ Time Frame: Approximately every 8 weeks with imaging ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety [ Time Frame: Ongoing but at least weekly ] [ Designated as safety issue: Yes ]

Enrollment: 61
Study Start Date: November 2007
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Cetuximab 500 mg/m2 IV over 2 hours every other week
Biological: cetuximab
Cetuximab 500 mg/m2 IV over 2 hours every other week
Other Name: Erbitux
Active Comparator: 2
Cetuximab 750 mg/m2 IV over 3 hours every other week
Biological: cetuximab
Cetuximab 750 mg/m2 IV over 3 hours every other week
Other Name: Erbitux

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00661427

Locations
United States, California
City of Hope National Medical Center
Duarte, California, United States, 91010-3000
United States, Florida
H. Lee Moffit Cancer Center and Research Institute
Tampa, Florida, United States, 33612
United States, Illinois
NorthShore University Health System
Evanston, Illinois, United States, 60201
United States, Missouri
Washington University School of Medicine
St Louis, Missouri, United States, 63110
United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198-7680
United States, New Jersey
Memorial Sloan-Kettering Cancer Center at Basking Ridge
Basking Ridge, New Jersey, United States, 07939
United States, New York
Memorial Sloan-Kettering Cancer Center at Commack
Commack, New York, United States, 11725
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
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
United States, Pennsylvania
Fox Chase Virtua Health Cancer Program
Philadelphia, Pennsylvania, United States, 08060
University of Pennsylvania - Abramson Cancer Center
Philadelphia, Pennsylvania, United States, 19104-4283
Pennsylvania Hospital
Philadelphia, Pennsylvania, United States, 19106
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Abramson Cancer Center University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Tennessee
University of Tennessee Cancer Institute
Memphis, Tennessee, United States, 38104
United States, Utah
Huntsman Cancer Institue
Salt Lake City, Utah, United States, 84112
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
ImClone LLC
National Comprehensive Cancer Network
Investigators
Principal Investigator: Matthew Fury, MD,PhD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00661427     History of Changes
Other Study ID Numbers: 08-039
Study First Received: January 7, 2008
Last Updated: August 17, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
Head and Neck cancer
Cetuximab

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Neoplasms, Squamous Cell
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Cetuximab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014