NCT00004866

DX-8951f in Treating Women Who Have Advanced or Recurrent Cancer of the Cervix

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: —
• Sponsor: Daiichi Sankyo · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cervical Cancer

Interventions

Type	Name	Description
DRUG	exatecan mesylate

Timeline

• Start date: 2000-01-01
• Primary completion: 2003-09-01
• Completion: 2003-09-01
• First posted: 2003-01-27
• Last updated: 2012-05-16

Locations

6 sites across 1 country: United States