A Phase II Study of Oxaliplatin in Patients With Advanced Carcinoma of the Head and Neck

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed squamous cell carcinoma
of the head and neck Recurrent or metastatic OR Locally advanced and judged incurable by
surgery or radiotherapy Bidimensionally measurable disease New and unirradiated lesion
within prior radiation field acceptable as measurable disease if at least 3 months since
prior radiotherapy No known brain metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 OR Karnofsky
50-100% Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Absolute
neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin
normal AST/ALT no greater than 2.5 times upper limit of normal Renal: Creatinine normal OR
Creatinine clearance at least 60 mL/min Cardiovascular: No symptomatic congestive heart
failure, unstable angina pectoris, or cardiac arrhythmia Other: Not pregnant or nursing
Negative pregnancy test Fertile patients must use effective contraception No evidence of
neuropathy No history of allergy to platinum compounds or to antiemetics appropriate for
administration in conjunction with protocol therapy No other concurrent uncontrolled
illness (e.g., ongoing or active infection) Not HIV positive AND receiving antiretroviral
therapy (HAART)

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior immunotherapy for head and neck
cancer No concurrent colony stimulating factors during first course of therapy
Chemotherapy: No prior chemotherapy for recurrent or metastatic disease At least 3 months
since prior chemotherapy as initial treatment Endocrine therapy: No prior hormonal therapy
for head and neck cancer Radiotherapy: See Disease Characteristics At least 3 months since
prior radiotherapy as initial treatment Surgery: See Disease Characteristics Prior surgery
allowed Other: No other concurrent investigational or commercial agents or therapies