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