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

Phase 2

Completed

• Conditions: Head and Neck Cancer; Thromboembolism

• Registration Number: NCT00020189
• Lead Sponsor: National Cancer Institute (NCI)

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.

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 Timeline

• Study Start: 2000-06
• Study First Submitted: 2001-07-11
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Status Verified: 2004-08
• Study Completion: 2004-08
• Last Update Submitted: 2013-06-17
• Last Update Posted: 2013-06-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (2)

Center for Cancer Research; 🇺🇸 Bethesda, Maryland, United States

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support; 🇺🇸 Bethesda, Maryland, United States