Liposomal Doxorubicin in Treating Patients With Liver or Bile Duct Cancer
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|ClinicalTrials.gov Identifier: NCT00003296|
Recruitment Status : Unknown
Verified September 2000 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : July 8, 2004
Last Update Posted : December 19, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Extrahepatic Bile Duct Cancer Gallbladder Cancer Liver Cancer||Biological: filgrastim Drug: pegylated liposomal doxorubicin hydrochloride||Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||26 participants|
|Official Title:||Phase II Study of TLC D-99 for Hepatobiliary Carcinomas|
|Study Start Date :||January 1998|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|