Overview

Rebeccamycin Analogue in Treating Patients With Advanced Liver and/or Biliary Cancer

Status:
Terminated
Trial end date:
2005-11-01
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 rebeccamycin analogue in treating patients who have advanced liver and/or biliary cancer.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Case Comprehensive Cancer Center
Collaborator:
National Cancer Institute (NCI)
Criteria
DISEASE CHARACTERISTICS:

- Diagnosis of advanced hepatobiliary carcinoma not amenable to conventional surgery

- Gall bladder carcinoma

- Cholangiocarcinoma

- Carcinoma of the ampulla

- Hepatocellular carcinoma (eligible for cohort II only)

- Measurable disease

- No known brain metastases

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- ECOG 0-2

Life expectancy:

- At least 12 weeks

Hematopoietic:

- WBC at least 3,000/mm^3

- Granulocyte count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3

- Hemoglobin greater than 10 g/dL

Hepatic:

- Bilirubin less than 3 mg/dL

- Cohort I (closed to accrual as of 11/1/03)

- Bilirubin no greater than 1.5 mg/dL

- AST no greater than 2.5 times upper limit of normal (ULN)

- Cohort II

- Bilirubin greater than 1.5 mg/dL and less than 3 mg/dL OR

- Bilirubin no greater 1.5 mg/dL AND AST greater than 2.5 times ULN

Renal:

- Creatinine normal OR

- Creatinine clearance at least 60 mL/min

Cardiovascular:

- No New York Heart Association class III or IV heart disease

Other:

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- No prior chemotherapy for cholangiocarcinoma or hepatobiliary carcinoma

Endocrine therapy:

- Not specified

Radiotherapy:

- Not specified

Surgery:

- Not specified

Other:

- No concurrent combination antiviral therapy for HIV-positive patients