Liver Cancer Clinical Trial
Official title:
Phase II and Pharmacokinetic Trial of Rebeccamycin Analog in Hepatobiliary Cancers
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.
;
Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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