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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 |
| 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 | |
| Study Chair: | Afshin Dowlati, MD | Case Comprehensive Cancer Center |
More Information
| 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 |