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Liposomal Doxorubicin in Treating Patients With Liver or Bile Duct Cancer

Primary Purpose

Extrahepatic Bile Duct Cancer, Gallbladder Cancer, Liver Cancer

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
filgrastim
pegylated liposomal doxorubicin hydrochloride
Sponsored by
Brown University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Extrahepatic Bile Duct Cancer focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • New England Medical Center Hospital
  • Brown University Oncology Group

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
December 18, 2013
Sponsor
Brown University
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1. Study Identification

Unique Protocol Identification Number
NCT00003296
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 Type
Interventional

2. Study Status

Record Verification Date
September 2000
Overall Recruitment Status
Unknown status
Study Start Date
January 1998 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Brown University

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Extrahepatic Bile Duct Cancer, Gallbladder Cancer, Liver Cancer
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Enrollment
26 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
filgrastim
Intervention Type
Drug
Intervention Name(s)
pegylated liposomal doxorubicin hydrochloride

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Howard Safran, MD
Organizational Affiliation
Brown University
Official's Role
Study Chair
Facility Information:
Facility Name
New England Medical Center Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Brown University Oncology Group
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02912
Country
United States

12. IPD Sharing Statement

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Liposomal Doxorubicin in Treating Patients With Liver or Bile Duct Cancer

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