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

Sponsor

National Cancer Institute (NCI) (NIH)

Overall Status

Completed

CT.gov ID

NCT00020189

Collaborator

(none)

Locations

Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Head and Neck Cancer Thromboembolism	Drug: acetylsalicylic acid Drug: alvocidib Drug: clopidogrel bisulfate	Phase 2

Detailed Description

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.

PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study within 1-3 years.

Study Design

Study Type:

Interventional

Primary Purpose:

Treatment

Official Title:

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)

Study Start Date :

Jun 1, 2000

Actual Study Completion Date :

Aug 1, 2004

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support	Bethesda	Maryland	United States	20892-1182
2	Center for Cancer Research	Bethesda	Maryland	United States	20892