Clinical Trial: DX-8951f in Treating Patients With Biliary Cancer

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase II Study of Intravenous DX-8951f Administered Daily for Five Days Every Three Weeks to Patients With Biliary Tree Cancer (Cholangiocarcinoma and Gallbladder Cancer

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 patients who have biliary cancer.

Detailed Summary:

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.

Sponsor: Daiichi Sankyo Inc.

Current Primary Outcome:

Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Daiichi Sankyo Inc.

Dates:
Date Received: July 5, 2000
Date Started: March 2000
Date Completion:
Last Updated: May 15, 2012
Last Verified: May 2012