Spots Global Cancer Trial Database for Liposomal Doxorubicin in Treating Patients With Liver or Bile Duct Cancer
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Trial Identification
Brief Title: Liposomal Doxorubicin in Treating Patients With Liver or Bile Duct Cancer
Official Title: Phase II Study of TLC D-99 for Hepatobiliary Carcinomas
Study ID: NCT00003296
Study Description
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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
New England Medical Center Hospital, Boston, Massachusetts, United States
Brown University Oncology Group, Providence, Rhode Island, United States
Contact Details
Name: Howard Safran, MD
Affiliation: Brown University
Role: STUDY_CHAIR
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