A Phase II Study of Intravenous DX-8951f Administered Daily for Five Days Every Three Weeks to Patients With Advanced or Recurrent Squamous Cell Cancer of the Cervix
OBJECTIVES:
- Determine the antitumor activity of DX-8951f in women with advanced or recurrent
squamous cell carcinoma of the cervix.
- Evaluate the quantitative and qualitative toxic effects of this regimen in these
patients.
- Evaluate the pharmacokinetics of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive DX-8951f IV over 30 minutes daily for 5 days. Courses repeat every 21 days
in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months until death.
PROJECTED ACCRUAL: Approximately 37 patients will be accrued for this study.
Interventional
Primary Purpose: Treatment
Robert L. DeJager, MD, FACP
Study Chair
Daiichi Sankyo Inc.
United States: Federal Government
CDR0000067525
NCT00004866
January 2000
September 2003
Name | Location |
---|---|
University of Texas - MD Anderson Cancer Center | Houston, Texas 77030-4009 |
Brookview Research, Inc. | Nashville, Tennessee 37203 |
Albert Einstein Clinical Cancer Center | Bronx, New York 10461 |
Texas Oncology PA (TOPA) at Baylor-Sammons | Dallas, Texas 75246 |
St. Luke's-Roosevelt Hospital | New York, New York 10019 |
Ruppert Health Center | Toledo, Ohio 43614 |