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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00020189
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : June 19, 2013
Information provided by:
National Cancer Institute (NCI)

July 11, 2001
January 27, 2003
June 19, 2013
June 2000
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Complete list of historical versions of study NCT00020189 on Archive Site
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Flavopiridol in Treating Patients With Recurrent or Metastatic Head and Neck Cancer
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)

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.


  • 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.

Phase 2
Primary Purpose: Treatment
  • Head and Neck Cancer
  • Thromboembolism
  • Drug: acetylsalicylic acid
  • Drug: alvocidib
  • Drug: clopidogrel bisulfate
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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August 2004
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  • 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



  • 18 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • Not specified


  • Platelet count greater than 100,000/mm^3
  • Absolute granulocyte count greater than 1,500/mm^3


  • 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)


  • 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


  • 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


  • No aspirin-induced asthma


  • 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


Biologic therapy:

  • No concurrent biologic therapy


  • 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


  • See Disease Characteristics
  • At least 4 weeks since prior radiotherapy and recovered
  • No concurrent radiotherapy


  • See Disease Characteristics
  • At least 4 weeks since prior surgery and recovered
  • No prior carotid endarterectomy or other revascularization surgery


  • 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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
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National Cancer Institute (NCI)
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Study Chair: Barbara A. Conley, MD National Cancer Institute (NCI)
National Cancer Institute (NCI)
August 2004

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP