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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)


Phase 2
18 Years
N/A
Not Enrolling
Both
Head and Neck Cancer, Thromboembolism

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Trial Information

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.

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

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Barbara A. Conley, MD

Investigator Role:

Study Chair

Investigator Affiliation:

National Cancer Institute (NCI)

Authority:

United States: Federal Government

Study ID:

CDR0000068028

NCT ID:

NCT00020189

Start Date:

June 2000

Completion Date:

August 2004

Related Keywords:

  • Head and Neck Cancer
  • Thromboembolism
  • 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
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms
  • Thromboembolism

Name

Location

Warren Grant Magnuson Clinical Center - NCI Clinical Studies SupportBethesda, Maryland  20892-1182
Center for Cancer ResearchBethesda, Maryland  20892