Overview

Liposomal Doxorubicin in Treating Patients With Liver or Bile Duct Cancer

Status:
Unknown status
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Brown University
Treatments:
Doxorubicin
Liposomal doxorubicin
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