A Phase II Study of Weekly Oxaliplatin and Gemcitabine Combination Chemotherapy for Recurrent or Metastatic Head and Neck Cancer

Inclusion Criteria:

- All patients must have histologically or cytologically confirmed diagnosis of
squamous cell carcinoma of the head and neck region. Primary tumor sites include:
lip, oral cavity, pharynx (oropharynx, hypopharynx), or larynx (supraglottis,
glottis, subglottis). For nasopharynx primary, all squamous histologic subtypes are
allowed (WHO type-I keratinizing, WHO type-II non-keratinizing, WHO type-III
undifferentiated).

- Patients must have metastatic or locally recurrent 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
disease must be assessed within 28 days prior to registration. All non-measurable
disease must be assessed within 42 days prior to registration.

- Patients must not have more than one prior chemotherapy regimen for
recurrent/metastatic disease. Patients with initial locally advanced but
non-metastatic disease are allowed to have one prior chemotherapy regimen as part of
the primary curative therapy. All chemotherapy must be completed 4 weeks prior to
registration. Any number of prior biologic therapies (e.g. chimeric antibodies or
kinase inhibitors) is permitted as part of the chemotherapy regimen.

- Patients may have received prior radiotherapy if there has been complete recovery
from all radiation-induced toxicities. At least 4 weeks must have been elapsed from
the completion of radiation therapy to the time of registration. If lesions within
the radiation port are to be used to assess response to therapy, those lesions must
have demonstrated clear progression following completion of radiation therapy.

- Patients must not have a surgical treatment procedure for head and neck cancer within
4 weeks prior to registration. Surgical procedure for biopsy purpose alone is allowed
within 28 days prior to registration. Patients must have completely recovered from
all surgery prior to registration.

Patients must not have prior therapy with oxaliplatin or gemcitabine

- Patients with any evidence of active or uncontrolled infection, recent myocardial
infection, unstable angina, or life threatening arrhythmia are not eligible.

- Patients with severe psychiatric disorder 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.

- No other prior malignancy is allowed except for adequately treated basal cell or
squamous cell carcinoma, in situ cervical cancer, or adequately treated Stage I and
II cancer from which the patient is in complete remission, or any other malignancy
from which the patient has been disease-free for 5 years.