Liposomal Doxorubicin in Treating Patients With Liver or Bile Duct Cancer

Phase 2

• Conditions: Extrahepatic Bile Duct Cancer; Gallbladder Cancer; Liver Cancer

• Registration Number: NCT00003296
• Lead Sponsor: Brown University

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 liposomal doxorubicin in treating patients with liver or bile duct cancer.

Detailed Description

OBJECTIVES: I. Determine the response rate and toxicity of doxorubicin HCl liposome in patients with carcinomas of the liver and bile ducts.

OUTLINE: Patients receive doxorubicin HCl liposome IV over 15 minutes every 21 days. Filgrastim (G-CSF) is administered subcutaneously starting on day 2 and continuing for 10-14 days. Disease is restaged after every 3 courses. Treatment continues in the absence of unacceptable toxicity or disease progression. Patients are followed every 3 months for the first year, and then every 6 months thereafter.

PROJECTED ACCRUAL: There will be 17-26 evaluable patients accrued into this study.

Study Timeline

• Study Start: 1998-01
• Study First Submitted: 1999-11-01
• Status Verified: 2000-09
• Study First Submitted QC: 2004-07-07
• Study First Posted: 2004-07-08
• Last Update Submitted: 2013-12-18
• Last Update Posted: 2013-12-19

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (2)

Brown University Oncology Group; 🇺🇸 Providence, Rhode Island, United States

New England Medical Center Hospital; 🇺🇸 Boston, Massachusetts, United States