Rituximab Plus Chemotherapy in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma

Inclusion criteria

• Histologically confirmed squamous cell carcinoma of head and neck.
• Locoregional recurrence and/or metastases after primary curative local treatment and unsuitable for further radiotherapy and surgery; or primary distant metastases at diagnosis.
• Measurable disease. Defined as presence of at least one lesion as being ≥10 mm in at least one dimension measured with conventional computed tomography (CT) or ≥10 mm in at least one dimension measured with spiral CT scan or magnetic resonance imaging (MRI)
• Eastern Cooperative Oncology Group performance status ≤2;
• Age between 20 and 65 years; and life expectancy of at least 12 weeks.
• Prior treatments with radiation therapy for palliative management of non-target lesion metastatic disease is permitted provided that at least 2 weeks have relapsed since the last fraction of radiation therapy, disease progression has been documented and all treatment related adverse events are ≦ grade 1 at the time of registration.
• Negative pregnancy test, Fertile patients must use effective contraception
• No history of allergic reactions attributed to Rituximab/cisplatin/gemcitabine
• Patient consent must be obtained

Exclusion criteria

• Presence of central nervous system (CNS) metastases;
• Presence of other malignancy with the exception of curatively treated non-melanoma skin cancer or cervical carcinoma in situ prior to entry into the study
• Presence of bone-only metastasis
• The organ function measured within 14 days prior to study entry as defined below: White blood cell (WBC) less than 2,000/mm3, absolute neutrophil count (ANC) less than 1,500/mm3, or platelets less than 100,000/mm3; serum bilirubin greater than 1.5 times the upper limit of normal range (ULN); alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 2.5 times the ULN if no demonstrable liver metastases, or greater than 5 times the ULN in the presence of liver metastases; creatinine clearance ≤60 ml/min (based upon urine collection);
• Concomitant illness including uncontrolled infection or other active, uncontrolled disease such as congestive heart failure, angina pectoris, respiratory insufficiency, and arrhythmia.
• Documented hypersensitivity to platinum compounds or compounds of similar chemical or biologic composition
• Pregnant or lactating women.
• Under rituximab treatment or have ever received rituximab within six months.
• Ongoing other concurrent investigational agents or anticancer therapy