Rebeccamycin Analogue in Treating Patients With Advanced Liver and/or Biliary Cancer
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.
Extrahepatic Bile Duct Cancer
|Study Design:||Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II and Pharmacokinetic Trial of Rebeccamycin Analog in Hepatobiliary Cancers|
- Determine the response rate in patients with advanced hepatobiliary carcinoma treated with rebeccamycin analogue. [ Time Frame: Patients are followed every 3 months. ] [ Designated as safety issue: No ]
- Assess the toxicity associated with this drug in this patient population. [ Time Frame: Patients are followed every 3 months. ] [ Designated as safety issue: Yes ]
|Study Start Date:||April 1999|
|Study Completion Date:||November 2005|
|Primary Completion Date:||April 2005 (Final data collection date for primary outcome measure)|
- rebeccamycin analogue
- rebeccamycin analogue, tartrate salt
- 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.
|United States, Alabama|
|Comprehensive Cancer Center at University of Alabama at Birmingham|
|Birmingham, Alabama, United States, 35294-3300|
|United States, Ohio|
|Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center|
|Cleveland, Ohio, United States, 44106-5065|
|United States, Pennsylvania|
|Hillman Cancer Center at University of Pittsburgh Cancer Institute|
|Pittsburgh, Pennsylvania, United States, 15213|
|Study Chair:||Afshin Dowlati, MD||Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center|