Liposomal Doxorubicin in Treating Patients With Liver or Bile Duct Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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Phase II Study of TLC D-99 for Hepatobiliary Carcinomas

Conditions
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Extrahepatic Bile Duct Cancer, Gallbladder Cancer, Liver Cancer

Intervention / Treatment
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* Biological: filgrastim
* Drug: pegylated liposomal doxorubicin hydrochloride


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed carcinoma of the liver or bile ducts including hepatocellular carcinoma, cholangiocarcinoma, and gallbladder cancer Measurable or evaluable disease by CT scan (ascites, pleural effusions, and bone metastases are not considered evaluable) PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin less than 3 mg/dL No severe cirrhosis Renal: Creatinine no greater than 3.0 mg/dL Cardiovascular: Left ventricular cardiac ejection fraction at least 45% Other: No allergy to egg or egg products Not pregnant or nursing Effective contraception required of all fertile patients PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior doxorubicin At least 4 weeks since prior chemotherapy Endocrine therapy: Not specified Radiotherapy: Prior radiotherapy allowed Surgery: Not specified

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: filgrastim|nan|
|Drug: pegylated liposomal doxorubicin hydrochloride|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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localized resectable adult primary liver cancer, localized unresectable adult primary liver cancer, advanced adult primary liver cancer, recurrent adult primary liver cancer, localized gallbladder cancer, unresectable gallbladder cancer, recurrent gallbladder cancer, localized extrahepatic bile duct cancer, unresectable extrahepatic bile duct cancer, recurrent extrahepatic bile duct cancer, adult primary hepatocellular carcinoma, cholangiocarcinoma of the gallbladder, cholangiocarcinoma of the extrahepatic bile duct, adult primary cholangiocellular carcinoma