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