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

NCT ID: NCT00005997

Phase II and Pharmacokinetic Trial of Rebeccamycin Analog in Hepatobiliary Cancers
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.
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.
Extrahepatic Bile Duct Cancer, Gallbladder Cancer, Liver Cancer
localized unresectable adult primary liver cancer, advanced adult primary liver cancer, unresectable gallbladder cancer, unresectable extrahepatic bile duct cancer, adult primary hepatocellular carcinoma, cholangiocarcinoma of the gallbladder, cholangiocarcinoma of the extrahepatic bile duct, adult primary cholangiocellular carcinoma
Case Comprehensive Cancer Center
Case Comprehensive Cancer Center, National Cancer Institute (NCI)
Last Updated
08 Jun 2010
Official Link
Dowlati A, Posey J, Ramanathan RK, Rath L, Fu P, Chak A, Krishnamurthi S, Brell J, Ingalls S, Hoppel CL, Ivy P, Remick SC. Phase II and pharmacokinetic trial of rebeccamycin analog in advanced biliary cancers. Cancer Chemother Pharmacol. 2009 Dec;65(1):73-8. doi: 10.1007/s00280-009-1005-x.

Dowlati A, Posey J, Ramanathan RK, et al.: Multicenter phase II and pharmacokinetic study of rebeccamycin analogue (RA) in advanced biliary cancers. [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-1070, 2003.

United States