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.
OBJECTIVES: * Determine the response rate in patients with advanced hepatobiliary carcinoma treated with rebeccamycin analogue. * Assess the toxicity associated with this drug in this patient population. * Evaluate the survival of this patient population treated with this drug. * Determine the pharmacokinetics of this drug in this patient population. OUTLINE: This is a partial dose-escalation study. Patients receive rebeccamycin analogue IV over 1 hour daily on days 1-5. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients are assigned to 1 of 2 cohorts according to hepatic dysfunction. (Cohort I closed to accrual as of 11/1/03.) * Cohort I (closed to accrual as of 11/1/03): Patients receive a fixed dose of rebeccamycin analogue. * Cohort II: Cohorts of 3-6 patients receive escalating doses of rebeccamycin analogue until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Patients are followed every 3 months. PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study within 6-37 months.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Masking
NONE
Enrollment
72
Cohorts of 3-6 patients receive escalating doses of rebeccamycin analogue until the maximum tolerated dose (MTD) is determined.
Comprehensive Cancer Center at University of Alabama at Birmingham
Birmingham, Alabama, United States
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States
Hillman Cancer Center at University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States
Determine the response rate in patients with advanced hepatobiliary carcinoma treated with rebeccamycin analogue.
Time frame: Patients are followed every 3 months.
Assess the toxicity associated with this drug in this patient population.
Time frame: Patients are followed every 3 months.
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