Clinical Trials Directory

Trials / Completed

CompletedNCT00033618

Ixabepilone in Treating Patients With Metastatic or Recurrent Squamous Cell Cancer of the Head and Neck

A Randomized Phase II Study of BMS-247550 (NSC #710428) Given Daily x 5 Days Every 3 Weeks or Weekly in Patients With Metastatic or Recurrent Squamous Cell Cancer of the Head and Neck

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
144 (actual)
Sponsor
National Cancer Institute (NCI) · NIH
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

Randomized phase II trial to study the effectiveness of ixabepilone in treating patients who have metastatic or recurrent head and neck cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die

Detailed description

PRIMARY OBJECTIVES: I. To determine the response rate and toxicity of BMS-247550 given in two dosing schedules in taxane-naïve and taxane-exposed patients. II. To provide information about the response rate and toxicity of BMS-247550 given in two dosing schedules. SECONDARY OBJECTIVES: I. To measure surviving expression and correlate with the therapeutic responsiveness to BMS-247550. II. To determine the changes in tumor vascular density and endothelial cell apoptosis in response to therapy and the correlation of these changes to outcome. OUTLINE: This is a randomized study. Patients are stratified according to prior taxane therapy (yes vs no) and ECOG performance status (0 vs 1). Patients are randomized to 1 of 2 treatment arms. Arm I: Patients receive ixabepilone IV over 1 hour on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Arm II: Patients receive ixabepilone IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. In both arms, patients achieving complete response (CR) receive 2 additional courses past CR if a minimum of 6 courses have been administered. Patients are followed every 3 months for 2 years and then every 6 months for 3 years.

Conditions

Interventions

TypeNameDescription
DRUGixabepiloneGiven IV
OTHERlaboratory biomarker analysisCorrelative studies

Timeline

Start date
2002-11-01
Primary completion
2007-01-01
First posted
2003-01-27
Last updated
2013-02-27

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00033618. Inclusion in this directory is not an endorsement.