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

June 17, 2013 updated by: National Cancer Institute (NCI)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Bethesda, Maryland, United States, 20892-1182
        • Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
      • Bethesda, Maryland, United States, 20892
        • Center for Cancer Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute (NCI)

Investigators

  • Study Chair: Barbara A. Conley, MD, National Cancer Institute (NCI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2000

Study Completion (Actual)

August 1, 2004

Study Registration Dates

First Submitted

July 11, 2001

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

June 19, 2013

Last Update Submitted That Met QC Criteria

June 17, 2013

Last Verified

August 1, 2004

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000068028
  • NCI-00-C-0128
  • MB-401
  • NCI-T99-0066

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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