Study of Albumin Bound-Paclitaxel for Treatment of Recurrent or Metastatic Head and Neck Cancer With Cetuximab

Inclusion Criteria:

• Each of the criteria in the following section must be met in order for a patient to be eligible for registration.
• Patients should have hemoglobin > 9 g/dL; patients may be transfused to achieve this level of hemoglobin.
• Alkaline phosphatase. Normal [26-110] IU/L
• Bone scan, if clinically indicated. < 2 x institutional upper limit of normal.
• Patients should not have known AIDS or HIV-1 associated complex or known history of immune or immunodeficiency disorders because of unknown or potential interactions of anti-retroviral therapy with Abraxane. Additionally, the severely depressed immune system found in HIV-infected patients and the possibility or premature death would compromise study objectives.
• Patients should not have active infection.
• Patients should not have psychological, familial, sociological, or geographical conditions that do not permit medical follow-up and compliance with study protocol.
• Patients should not have any immediate life-threatening complications of their malignancies.
• 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 ANC >=1,500 ul and platelets > 100,000/ ul 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.
• Patients must not have prior therapy with Abraxane; this will enable the researchers to assess the patient response rate in patients that have not been treated with Abraxane. If any patient has been treated with Abraxane outside of this study and they are responding the patient would probably continue to be treated as such in their best interest. Patients who have been treated with other taxanes (not Abraxane) previously, can still respond to this new formulation.
• Patients with any evidence of active or uncontrolled infection, recent myocardial infection, unstable angina, or life-threatening arrhythmia are not eligible. Potential subjects will be screened for any pre-existing heart conditions.
• 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.
• Patients who are pregnant are not eligible. There is not enough medical information to know what the risks might be to a breast-fed infant or to an unborn child carried by a mother who is taking part in the study. If patient is of childbearing age, sexual partner and the patient must use proven birth control measures while on the study. Effective methods of contraception are oral contraceptives, diaphragm, condom, contraceptive foam or male/female sterilization. If the patient is breast-feeding, they must stop breast-feeding. If the patient is still having period and can become pregnant, a pregnancy test must be done before taking part in the study. The pregnancy test must be taken 7 days prior to taking part in the study. If the pregnancy test is positive, the patient will not be able to take part in the study.
• Sample size justification: On average about 75 head and neck cancer patients are treated at UCI annually. One third of these patients will eventually require and receive chemotherapy for the study disease. Therefore an accrual period of 2 years is expected to accrue a total of 44 patients.
• It is assumed that the Abraxane therapy will be of no further interest if the true confirmed response rate is < 5%, but will warrant further study if the response rate is > 20%. Utilizing a two-stage design and statistical tools from the Southwest Oncology Group (SWOG) [http://www.swogstat.org/statoolsout.html] and assuming a power of 90% and a significance level of 5% for sample size calculation, for the first stage of the study, a total of 20 eligible patients will be enrolled. The trial will proceed to the second stage if at least 1 patient achieves a partial or complete response to Abraxane. Given an estimated 10% drop-out rate, 22 patients will be enrolled at stage 1 and 22 patients will be enrolled in stage 2 for a total number of 44 patients enrolled. If a total of at least 5 patients achieve a partial or complete response to Abraxane, the regimen will be considered as worthy of further study.