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Liposomal Doxorubicin in Treating Patients With Liver or Bile Duct Cancer

NCT ID: NCT00003296

Last Updated: 2013-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

1998-01-31

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.

Conditions

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Extrahepatic Bile Duct Cancer Gallbladder Cancer Liver Cancer

Keywords

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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

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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filgrastim

Intervention Type BIOLOGICAL

pegylated liposomal doxorubicin hydrochloride

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Brown University

OTHER

Sponsor Role lead

Principal Investigators

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Howard Safran, MD

Role: STUDY_CHAIR

Brown University

Locations

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New England Medical Center Hospital

Boston, Massachusetts, United States

Site Status

Brown University Oncology Group

Providence, Rhode Island, United States

Site Status

Countries

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United States

Other Identifiers

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BRUOG-HB-71

Identifier Type: -

Identifier Source: secondary_id

NCI-V98-1408

Identifier Type: -

Identifier Source: secondary_id

CDR0000066230

Identifier Type: -

Identifier Source: org_study_id