DX-8951f in Treating Patients With Biliary Cancer

Status Completed

Clinical Trial 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 patients who have biliary cancer.

Clinical Trial Description

OBJECTIVES: I. Determine the antitumor activity of DX-8951f in terms of antitumor response, response duration, and survival in patients with biliary tree cancer. II. Evaluate the quantitative and qualitative toxicities of this treatment regimen in this patient population. III. Evaluate the pharmacokinetics of DX-8951 in plasma.

OUTLINE: Patients receive DX-8951f IV over 30 minutes daily for 5 days. Treatment repeats every 3 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for survival.

PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study within 12 months. ;

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00005938
Study type	Interventional
Source	Daiichi Sankyo Inc.
Contact
Status	Completed
Phase	Phase 2
Start date	March 2000
Completion date	April 2005

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