Liposomal Doxorubicin in Treating Patients With Liver or Bile Duct Cancer
Recruitment status was: Active, not recruiting
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.
|Extrahepatic Bile Duct Cancer Gallbladder Cancer Liver Cancer||Biological: filgrastim Drug: pegylated liposomal doxorubicin hydrochloride||Phase 2|
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Phase II Study of TLC D-99 for Hepatobiliary Carcinomas|
|Study Start Date:||January 1998|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003296
|United States, Massachusetts|
|New England Medical Center Hospital|
|Boston, Massachusetts, United States, 02111|
|United States, Rhode Island|
|Brown University Oncology Group|
|Providence, Rhode Island, United States, 02912|
|Study Chair:||Howard Safran, MD||Brown University|