NCT00005997

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

Phase II and Pharmacokinetic Trial of Rebeccamycin Analog in Hepatobiliary Cancers

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Case Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Extrahepatic Bile Duct Cancer
• Gallbladder Cancer
• Liver Cancer

Interventions

Type	Name	Description
DRUG	becatecarin	Cohorts of 3-6 patients receive escalating doses of rebeccamycin analogue until the maximum tolerated dose (MTD) is determined.

Timeline

• Start date: 1999-04-01
• Primary completion: 2005-04-01
• Completion: 2005-11-01
• First posted: 2003-01-27
• Last updated: 2010-06-11

Locations

3 sites across 1 country: United States