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Clinical Trials/NCT00004866
NCT00004866CompletedPhase 2

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

Daiichi Sankyo11 sites in 1 countryStarted: January 2000Last updated:
Conditions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Completed
Locations
11

Study Overview

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.

Study Design

Study Type
Interventional
Primary Purpose
Treatment

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (11)

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