DX-8951f in Treating Women Who Have Advanced or Recurrent Cancer of the Cervix
- Conditions
- Cervical Cancer
- Registration Number
- NCT00004866
- Lead Sponsor
- Daiichi Sankyo
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (6)
Albert Einstein Clinical Cancer Center
🇺🇸Bronx, New York, United States
St. Luke's-Roosevelt Hospital
🇺🇸New York, New York, United States
Brookview Research, Inc.
🇺🇸Nashville, Tennessee, United States
Ruppert Health Center
🇺🇸Toledo, Ohio, United States
University of Texas - MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Texas Oncology PA (TOPA) at Baylor-Sammons
🇺🇸Dallas, Texas, United States