Study of Albumin Bound-Paclitaxel for Treatment of Recurrent or Metastatic Head and Neck Cancer With Cetuximab
Condition: Head and Neck Cancer
MeSH terms: Head and Neck Neoplasms
Intervention: Abraxane; Cetuximab
Intervention description: 260 mg/m2 IV over 30 minutes every 3 weeks; Cetuximab will be added to Abraxane if there is documented progression on single agent Abraxane. First dose: 400 mg/m2 IV over 120 minutes. Weekly: 250 mg/m2 IV over 60 minutes Days 8 and 15 of cycle 1 and days 1, 8, 15 of all subsequent cycles
Intervention MeSH terms: Paclitaxel; Cetuximab; Albumin-Bound Paclitaxel
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Head cancer; Neck cancer; cetuximab; abraxane; erbitux; IMC-225; NSC-714692

Summary:

      Primary Objective: To assess the overall response rate (complete and partial response) to
      Abraxane in patients with recurrent or metastatic head and neck cancer with the addition of
      Cetuximab on disease progression.

      Approximately 40,000 new cases of head and neck cancer are diagnosed annually in the United
      States (Jemal et al, 2003), and over 30% of these patients are expected to die of their
      malignancy. Squamous cell carcinoma accounts for more than 90% of head and neck cancer cases.
      Although metastatic disease at the time of diagnosis is rather uncommon, and despite
      aggressive use of up-front concurrent radiation and cisplatin-based chemotherapy,
      approximately 20% of the patients will develop metastases. Patients with recurrent or
      metastatic squamous cell carcinoma of the head and neck (SCCHN) have a poor prognosis

      A subsequent randomized study conducted by ECOG (E1393) compared high-dose paclitaxel (200
      mg/m2) as a 24-hour infusion plus cisplatin 75 mg/m2 with G-CSF support, to low dose
      paclitaxel (135 mg/m2) as a 24-hour infusion, plus cisplatin 75 mg/m2 (Forastiere et al,
      2001). Patients with newly diagnosed metastatic or recurrent squamous cell carcinoma of the
      head and neck, excluding nasopharyngeal primaries were eligible. No prior treatment for
      recurrent/metastatic disease was allowed, but patients could have received chemotherapy as a
      part of the initial curative therapy that should have been completed 6 months prior to study.

      No statistically significant difference could be demonstrated either in response rates or
      survival between the two arms (Murphy et al, 2001). This study, however, indicated that
      paclitaxel, a member of the taxane class of anti-tumor agent, is active in head and neck
      cancer.

      New agents to treat head and neck cancer need to be investigated. Abraxane, an albumin-bound
      formulation of paclitaxel has shown significant single-agent activity in breast cancer and in
      head and neck cancer. Recently, Abraxane has approved for use in metastatic breast cancer.
      Given previous randomized phase III trials indicated single agent chemotherapy fared as well
      as combination chemotherapy regimen in terms of overall survival, this novel formulation
      should be actively investigated in head and neck cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All patients must have histologically or cytologically confirmed carcinoma of the head
             and neck region. Primary tumor sites include: lip and oral cavity, major salivary
             glands, pharynx (oropharynx, nasopharynx, hypopharynx), or larynx (supraglottis,
             glottis, subglottis), nasal cavity and paranasal sinuses, and thyroid

          -  Patients must have metastatic or locally recurrent squamous cell carcinoma of the head
             and neck. Patients with locoregional disease must be considered incurable by means of
             locoregional therapy.

          -  All sites of disease must be assessed and designated as measurable or non-measurable
             disease as documented by CT, MRI, X-ray physical exam or nuclear exam. All measurable
             and non-measurable disease must be assessed within 28 days prior to registration.

          -  Patients may have prior chemotherapy for recurrent/metastatic disease. However, all
             chemotherapy must be completed at least 21 days prior to scheduled start of Abraxane.

          -  Patients must have adequate bone marrow reserve as documented by absolute neutrophil
             count (ANC) > 1,500 μl and platelets > 100,000/ μl obtained within 14 days prior to
             registration.

          -  Patients must have adequate hepatic as documented by serum bilirubin < 1.5 x the
             institutional upper limit of normal. These tests must be obtained within 14 days prior
             to registration.

          -  All patients must be 18 years of age or older

          -  Patients must have a Zubrod performance of 0-3

        Exclusion Criteria:

          -  Patients must not have prior therapy with Abraxane

          -  Patients with any evidence of active or uncontrolled infection, recent myocardial
             infection, unstable angina, or life-threatening arrhythmia are not eligible.

          -  Patients with baseline grade 3 peripheral neuropathy are not eligible.

          -  Patients with known brain metastasis are not eligible. However, brain-imaging studies
             are not required for eligibility if the patient has no neurological signs or symptoms.
             If brain-imaging studies are performed, they must be negative for disease.