Flavopiridol in Treating Patients With Recurrent or Metastatic Head and Neck Cancer

• Status: Completed
• Trial end date: 2004-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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

PURPOSE: Phase II trial to study the effectiveness of flavopiridol in treating patients who have recurrent or metastatic head and neck cancer.

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

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Alvocidib; Aspirin; Clopidogrel

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