Rebeccamycin Analogue in Treating Patients With Advanced Liver and/or Biliary Cancer
- Conditions
- Extrahepatic Bile Duct CancerGallbladder CancerLiver Cancer
- Registration Number
- NCT00005997
- Lead Sponsor
- Case Comprehensive Cancer Center
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 72
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Determine the response rate in patients with advanced hepatobiliary carcinoma treated with rebeccamycin analogue. Patients are followed every 3 months.
- Secondary Outcome Measures
Name Time Method Assess the toxicity associated with this drug in this patient population. Patients are followed every 3 months.
Trial Locations
- Locations (3)
Comprehensive Cancer Center at University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
🇺🇸Cleveland, Ohio, United States
Hillman Cancer Center at University of Pittsburgh Cancer Institute
🇺🇸Pittsburgh, Pennsylvania, United States