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

This study has been terminated.
(slow accrual for Cohort II)
Sponsor:
Collaborator:
Information provided by:
Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00005997
First received: July 5, 2000
Last updated: June 9, 2010
Last verified: June 2010
  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 2

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Case Comprehensive Cancer Center:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Assess the toxicity associated with this drug in this patient population. [ Time Frame: Patients are followed every 3 months. ] [ Designated as safety issue: Yes ]

Enrollment: 72
Study Start Date: April 1999
Study Completion Date: November 2005
Primary Completion Date: April 2005 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: becatecarin
    Cohorts of 3-6 patients receive escalating doses of rebeccamycin analogue until the maximum tolerated dose (MTD) is determined.
    Other Names:
    • DEAE-rebeccamycin
    • rebeccamycin analogue
    • rebeccamycin analogue, tartrate salt
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, 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
Sponsors and Collaborators
Case Comprehensive Cancer Center
Investigators
Study Chair: Afshin Dowlati, MD Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
  More 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.

Responsible Party: Afshin Dowlati MD, Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00005997     History of Changes
Other Study ID Numbers: CWRU2299, U01CA063200, P30CA043703, CWRU-2299, NCI-96
Study First Received: July 5, 2000
Last Updated: June 9, 2010
Health Authority: United States: Federal Government
United States: Food and Drug Administration

Keywords provided by Case Comprehensive Cancer Center:
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

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

ClinicalTrials.gov processed this record on July 22, 2014