DX-8951f in Treating Women Who Have Advanced or Recurrent Cancer of the Cervix
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of DX-8951f in treating women who have advanced or recurrent cancer of the cervix.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||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|
|Study Start Date:||January 2000|
|Study Completion Date:||September 2003|
|Primary Completion Date:||September 2003 (Final data collection date for primary outcome measure)|
- 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.
|United States, New York|
|Albert Einstein Clinical Cancer Center|
|Bronx, New York, United States, 10461|
|St. Luke's-Roosevelt Hospital|
|New York, New York, United States, 10019|
|United States, Ohio|
|Ruppert Health Center|
|Toledo, Ohio, United States, 43614|
|United States, Tennessee|
|Brookview Research, Inc.|
|Nashville, Tennessee, United States, 37203|
|United States, Texas|
|Texas Oncology PA (TOPA) at Baylor-Sammons|
|Dallas, Texas, United States, 75246|
|University of Texas - MD Anderson Cancer Center|
|Houston, Texas, United States, 77030-4009|
|Study Chair:||Robert L. DeJager, MD, FACP||Daiichi Sankyo Inc.|