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| 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 Liver Cancer |
| ChemIDplus related topics: | BMS 181176 |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | Phase II and Pharmacokinetic Trial of Rebeccamycin Analog in Hepatobiliary Cancers |
| Study Start Date: | April 1999 |
OBJECTIVES:
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.)
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 |
DISEASE CHARACTERISTICS:
Diagnosis of advanced hepatobiliary carcinoma not amenable to conventional surgery
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Bilirubin less than 3 mg/dL
Cohort I (closed to accrual as of 11/1/03)
Cohort II
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and 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 | |||||
| Ireland Cancer Center |
| National Cancer Institute (NCI) |
| Study Chair: | Afshin Dowlati, MD | Case Comprehensive Cancer Center |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
| 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 |
| First Received: | July 5, 2000 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00005997 |
| Health Authority: | United States: Federal Government |
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