Spots Global Cancer Trial Database for DX-8951f in Treating Women Who Have Advanced or Recurrent Cancer of the Cervix

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Trial Identification

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

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 ID: NCT00004866

Conditions

Cervical Cancer

Interventions

exatecan mesylate

Study Description

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.