A Phase II Trial of Daily Bolus Flavopiridol for Five Consecutive Days in Patients With Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)

OBJECTIVES:

• Determine the standard response rate (complete response and partial response) and duration of response in patients with recurrent or metastatic squamous cell carcinoma of the head and neck treated with flavopiridol.
• Determine the qualitative and quantitative toxic effects of this regimen in these patients.
• Determine the progression-free and overall survival of patients treated with this regimen.
• Determine the effects of anti-platelet agents, aspirin and clopidogrel bisulfate, on the pharmacology of flavopiridol in these patients.
• Determine the effects of prophylactic anticoagulation with anti-platelet agents, aspirin and clopidogrel bisulfate, on the incidence of flavopiridol-related thrombosis in these patients.

OUTLINE: Patients receive flavopiridol IV over 1 hour on days 1-5. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.

Patients also receive oral aspirin and clopidogrel bisulfate beginning on day 0 and continuing throughout the study.

Patients are followed until death.