Clinical Trial: Rebeccamycin Analogue in Treating Patients With Advanced Liver and/or Biliary Cancer
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: Phase II and Pharmacokinetic Trial of Rebeccamycin Analog in Hepatobiliary Cancers
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 Summary:
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.
Sponsor: Case Comprehensive Cancer Center
Current Primary Outcome: Determine the response rate in patients with advanced hepatobiliary carcinoma treated with rebeccamycin analogue. [ Time Frame: Patients are followed every 3 months. ]
Original Primary Outcome:
Current Secondary Outcome: Assess the toxicity associated with this drug in this patient population. [ Time Frame: Patients are followed every 3 months. ]
Original Secondary Outcome:
Information By: Case Comprehensive Cancer Center
Dates:
Date Received: July 5, 2000
Date Started: April 1999
Date Completion:
Last Updated: June 9, 2010
Last Verified: June 2010