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NCT00003296 Clinical Trial

Liposomal Doxorubicin in Treating Patients With Liver or Bile Duct Cancer

Liver Cancer Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT00003296
Other study ID # CDR0000066230
Secondary ID BRUOG-HB-71NCI-V
Status Active, not recruiting
Phase Phase 2
First received November 1, 1999
Last updated December 18, 2013
Start date January 1998

Study information
Verified date September 2000
Source National Cancer Institute (NCI)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 26
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Biological:
• filgrastim

Drug:
• pegylated liposomal doxorubicin hydrochloride

Locations
Country Name City State
United States New England Medical Center Hospital Boston Massachusetts
United States Brown University Oncology Group Providence Rhode Island

Sponsors (1)
Lead Sponsor Collaborator
Brown University

Country where clinical trial is conducted

United States, 

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