NCT00003296

Liposomal Doxorubicin in Treating Patients With Liver or Bile Duct Cancer

Phase II Study of TLC D-99 for Hepatobiliary Carcinomas

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 26 (estimated)
• Sponsor: Brown University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Extrahepatic Bile Duct Cancer
• Gallbladder Cancer
• Liver Cancer

Interventions

Type	Name	Description
BIOLOGICAL	filgrastim
DRUG	pegylated liposomal doxorubicin hydrochloride

Timeline

• Start date: 1998-01-01
• First posted: 2004-07-08
• Last updated: 2013-12-19

Locations

2 sites across 1 country: United States