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Rebeccamycin Analogue in Treating Patients With Advanced Liver and/or Biliary Cancer
This study has been completed.
First Received: July 5, 2000   Last Updated: July 23, 2008   History of Changes
Sponsors and Collaborators: Ireland Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00005997
  Purpose

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.


Condition Intervention Phase
Extrahepatic Bile Duct Cancer
Gallbladder Cancer
Liver Cancer
Drug: becatecarin
Phase II

MedlinePlus related topics: Cancer Gallbladder Cancer Liver Cancer
Drug Information available for: BMS 181176
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: Phase II and Pharmacokinetic Trial of Rebeccamycin Analog in Hepatobiliary Cancers

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: April 1999
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of advanced hepatobiliary carcinoma not amenable to conventional surgery

    • Gall bladder carcinoma
    • Cholangiocarcinoma
    • Carcinoma of the ampulla
    • Hepatocellular carcinoma (eligible for cohort II only)
  • Measurable disease
  • No known brain metastases

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • At least 12 weeks

Hematopoietic:

  • WBC at least 3,000/mm^3
  • Granulocyte count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • Hemoglobin greater than 10 g/dL

Hepatic:

  • Bilirubin less than 3 mg/dL

    • Cohort I (closed to accrual as of 11/1/03)

      • Bilirubin no greater than 1.5 mg/dL
      • AST no greater than 2.5 times upper limit of normal (ULN)
    • Cohort II

      • Bilirubin greater than 1.5 mg/dL and less than 3 mg/dL OR
      • Bilirubin no greater 1.5 mg/dL AND AST greater than 2.5 times ULN

Renal:

  • Creatinine normal OR
  • Creatinine clearance at least 60 mL/min

Cardiovascular:

  • No New York Heart Association class III or IV heart disease

Other:

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • No prior chemotherapy for cholangiocarcinoma or hepatobiliary carcinoma

Endocrine therapy:

  • Not specified

Radiotherapy:

  • Not specified

Surgery:

  • Not specified

Other:

  • No concurrent combination antiviral therapy for HIV-positive patients
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005997

Locations
United States, Alabama
Comprehensive Cancer Center at University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294-3300
United States, Massachusetts
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
United States, Michigan
Josephine Ford Cancer Center at Henry Ford Health System
Detroit, Michigan, United States, 48202
United States, New York
Albert Einstein Cancer Center at Albert Einstein College of Medicine
Bronx, New York, United States, 10461
United States, Ohio
Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University
Cleveland, Ohio, United States, 44106-5065
United States, Pennsylvania
Hillman Cancer Center at University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
Ireland Cancer Center
Investigators
Study Chair: Afshin Dowlati, MD Case Comprehensive Cancer Center
  More Information

Additional Information:
Publications:
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.

Study ID Numbers: CDR0000068001, CWRU-2299, NCI-96
Study First Received: July 5, 2000
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00005997     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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

Study placed in the following topic categories:
Gallbladder Diseases
Cholangiocarcinoma
Liver Diseases
Biliary Tract Neoplasms
Digestive System Neoplasms
Carcinoma, Hepatocellular
Bile Duct Cancer, Extrahepatic
Carcinoma
Liver Neoplasms
Gall Bladder Cancer
Digestive System Diseases
Bile Duct Diseases
Biliary Tract Diseases
Gastrointestinal Neoplasms
Biliary Tract Cancer
Gallbladder Neoplasms
Bile Duct Neoplasms
Hepatocellular Carcinoma

Additional relevant MeSH terms:
Gallbladder Diseases
Liver Neoplasms
Liver Diseases
Neoplasms
Digestive System Diseases
Neoplasms by Site
Digestive System Neoplasms
Biliary Tract Neoplasms
Bile Duct Diseases
Biliary Tract Diseases
Bile Duct Neoplasms
Gallbladder Neoplasms

ClinicalTrials.gov processed this record on May 07, 2009