Spots Global Cancer Trial Database for Rebeccamycin Analogue in Treating Patients With Advanced Liver and/or Biliary Cancer

Study Description

Brief 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.

Detailed Description: 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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

Useful links and downloads for this trial