Oxaliplatin in Treating Patients With Advanced Head and Neck Cancer

• Status: Completed
• Trial end date: 2004-03-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of oxaliplatin in treating patients who have advanced head and neck cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ohio State University Comprehensive Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Oxaliplatin

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