Flavopiridol in Treating Patients With Recurrent or Metastatic Head and Neck Cancer
Head and Neck Cancer, Thromboembolism
About this trial
This is an interventional treatment trial for Head and Neck Cancer focused on measuring thromboembolism, untreated metastatic squamous neck cancer with occult primary, recurrent metastatic squamous neck cancer with occult primary, metastatic squamous neck cancer with occult primary squamous cell carcinoma, stage IV squamous cell carcinoma of the lip and oral cavity, recurrent squamous cell carcinoma of the lip and oral cavity, stage IV squamous cell carcinoma of the oropharynx, recurrent squamous cell carcinoma of the oropharynx, stage IV squamous cell carcinoma of the hypopharynx, recurrent squamous cell carcinoma of the hypopharynx, stage IV squamous cell carcinoma of the larynx, recurrent squamous cell carcinoma of the larynx, stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity, recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity, recurrent salivary gland cancer, salivary gland squamous cell carcinoma, stage IV salivary gland cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically proven squamous cell carcinoma of the head and neck Metastatic disease at diagnosis OR Persistent, metastatic, or recurrent disease after prior definitive surgery and/or radiotherapy No undifferentiated and nonkeratinizing carcinomas, including lymphoepitheliomas of all locations No nasopharynx tumors Bidimensionally measurable disease Patients whose only measurable disease is within a prior radiotherapy port must have clearly progressive disease No metastatic or leptomeningeal CNS disease PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Platelet count greater than 100,000/mm^3 Absolute granulocyte count greater than 1,500/mm^3 Hepatic: See Other (Prior/Concurrent Therapy) SGOT and SGPT less than 2.5 times normal Bilirubin less than 1.5 times normal No history of hypercoagulopathies (e.g., protein C deficiency, protein S deficiency, or lupus anticoagulant) Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min Calcium no greater than normal No hypercalcemia refractory to bisphosphonates Cardiovascular: No unstable or newly diagnosed angina pectoris No myocardial infarction within the past 6 months No class II-IV congestive heart failure No history of symptomatic carotid disease No concurrent asymptomatic carotid artery occlusion (70% or greater) in one or both arteries by Doppler ultrasound No symptomatic atherosclerosis No thrombotic events within the past 6 months Pulmonary: No aspirin-induced asthma Other: No inability to take aspirin or clopidogrel bisulfate due to contraindications, allergies, or pre-existing medical conditions (e.g., active peptic ulcer disease or history of undiagnosed non-occult, non-hemorrhoidal gastrointestinal or other bleeding sources within the past 6 months) No other prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer that is currently in complete remission HIV negative Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 3 months after study PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent biologic therapy Chemotherapy: At least 4 weeks since prior chemotherapy and recovered No prior flavopiridol No more than 3 prior systemic chemotherapy regimens for recurrent or metastatic disease No other concurrent chemotherapy Endocrine therapy: No concurrent hormonal therapy except oral contraceptives Radiotherapy: See Disease Characteristics At least 4 weeks since prior radiotherapy and recovered No concurrent radiotherapy Surgery: See Disease Characteristics At least 4 weeks since prior surgery and recovered No prior carotid endarterectomy or other revascularization surgery Other: No other concurrent antineoplastic therapies No active anticoagulation with INR 1.5 or greater No low-molecular weight heparin or equivalent Concurrent bisphosphonates for calcium maintenance allowed
Sites / Locations
- Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
- Center for Cancer Research