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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
N/A
Not Enrolling
Both
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
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.

Type of Study:

Interventional

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:

No

Principal Investigator

Matthew Fury, MD,PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

08-039

NCT ID:

NCT00661427

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

Name

Location

Memorial Sloan Kettering Cancer CenterNew York, New York  10021
Washington University School of MedicineSaint Louis, Missouri  63110
Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
Pennsylvania HospitalPhiladelphia, Pennsylvania  19107
University of Nebraska Medical CenterOmaha, Nebraska  68198-3330
University of Tennessee Cancer InstituteMemphis, Tennessee  38103
City of Hope National Medical CenterLos Angeles, California  91010
Huntsman Cancer InstitueSalt Lake City, Utah  84112
Memorial Sloan-Kettering Cancer Center at Basking RidgeBasking Ridge, New Jersey  07920
Memorial Sloan-Kettering Cancer Center at CommackCommack, New York  11725
Memorial Sloan-Kettering at Mercy Medical CenterRockville Centre, New York  
Memoral Sloan Kettering Cancer Center@PhelpsSleepy Hollow, New York  
NorthShore University health systemEvanston, Illinois  60201
H. Lee Moffit Cancer Center and Research InstituteTampa, Florida  33612
Fox Chase Virtua Health Cancer ProgramPhiladelphia, Pennsylvania  08060
University of Pennsylvania - Abramson Cancer CenterPhiladelphia, Pennsylvania  19104-4283
Abramson Cancer Center University of PennsylvaniaPhiladelphia, Pennsylvania  19104