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Phase II Study of TLC D-99 for Hepatobiliary Carcinomas

Phase 2
18 Years
Open (Enrolling)
Extrahepatic Bile Duct Cancer, Gallbladder Cancer, Liver Cancer

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Trial Information

Phase II Study of TLC D-99 for Hepatobiliary Carcinomas

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.

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

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Howard Safran, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Brown University


United States: Federal Government

Study ID:




Start Date:

January 1998

Completion Date:

Related Keywords:

  • Extrahepatic Bile Duct Cancer
  • Gallbladder Cancer
  • Liver Cancer
  • 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
  • Liver Neoplasms
  • Gallbladder Neoplasms
  • Bile Duct Neoplasms



New England Medical Center Hospital Boston, Massachusetts  02111
Brown University Oncology Group Providence, Rhode Island  02912