Weekly Oxaliplatin and Gemcitabine 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 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 have adequate bone marrow reserve as documented by absolute neutrophil count (ANC) \> 1,500 microliters and platelets \> 100,000/microliter 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. Serum transaminase (SGOT or SGPT) must be \< 1.5 x the institutional upper limit of normal serum unless the liver is involved with tumor, in which case serum transaminase (SGOT or SGPT) must be \< 5 x the institutional limit of normal. These tests must be obtained within 14 days prior to registration.
• •Patients must have a creatinine \< 1.5 x the institutional upper limit of normal or a creatinine clearance of \> 30 cc/min calculated using the following formula obtained within 28 days prior to registration.
• •Calculated Creatinine Clearance = (140-age) X wt (kg) X (0.85 if female) 72 X creatinine (mg/dl)
• •These tests must have been performed within 28 days prior to registration.
• •All patients must be 18 years of age or older
• •Patients must have a Zubrod performance of 0-2