Cetuximab at Either 500 or 750 mg/m2 Every Other Week for Recurrent or Metastatic Head and Neck Squamous Cell Cancer
Condition: Head and Neck; Squamous Cell Cancer
MeSH terms: Neoplasms, Squamous Cell; Carcinoma, Squamous Cell
Intervention: cetuximab; cetuximab
Intervention description: Cetuximab 500 mg/m^2 IV over 2 hours every other week; Cetuximab 750 mg/m^2 IV over 3 hours every other week
Intervention MeSH terms: Cetuximab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 61.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Head and Neck cancer; Cetuximab

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.