Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsors and Collaborators: |
Ireland Cancer Center National Cancer Institute (NCI) |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00005997 |
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 |
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.
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:
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 |
Study Chair: | Afshin Dowlati, MD | Case Comprehensive Cancer Center |
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 |
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 |
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 |
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 |