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| Sponsors and Collaborators: |
University of Chicago National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00023946 |
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 BMS-247550 in treating patients who have liver or gallbladder cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Extrahepatic Bile Duct Cancer Gallbladder Cancer Liver Cancer |
Drug: ixabepilone |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | A Phase II Trial Of The Epothilone B Analog BMS-247550 (NSC 710428D) In Patients With Hepatobiliary Cancer |
| Study Start Date: | October 2001 |
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients receive BMS-247550 IV over 3 hours on day 1. Treatment repeats every 21 days for at least 2 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 6 weeks until disease progression.
PROJECTED ACCRUAL: A total of 21-50 patients will be accrued for this study within 14 months.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed locally advanced, metastatic, or recurrent hepatobiliary cancer
At least 1 unidimensionally measurable lesion
The following are not considered measurable lesions:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations| United States, California | |
| USC/Norris Comprehensive Cancer Center and Hospital | |
| Los Angeles, California, United States, 90033 | |
| United States, Illinois | |
| Cardinal Bernardin Cancer Center at Loyola University Medical Center | |
| Maywood, Illinois, United States, 60153 | |
| Central Illinois Hematology Oncology Center | |
| Springfield, Illinois, United States, 62701 | |
| La Grange Memorial Hospital | |
| La Grange, Illinois, United States, 60525 | |
| Evanston Northwestern Health Care - Evanston Hospital | |
| Evanston, Illinois, United States, 60201-1781 | |
| Ingalls Cancer Care Center at Ingalls Memorial Hospital | |
| Harvey, Illinois, United States, 60426 | |
| Decatur Memorial Hospital Cancer Care Institute | |
| Decatur, Illinois, United States, 62526 | |
| Louis A. Weiss Memorial Hospital | |
| Chicago, Illinois, United States, 60640 | |
| Oncology/Hematology Associates of Central Illinois, P.C. | |
| Peoria, Illinois, United States, 61615-7828 | |
| University of Chicago Cancer Research Center | |
| Chicago, Illinois, United States, 60637-1470 | |
| University of Illinois Medical Center | |
| Chicago, Illinois, United States, 60612 | |
| United States, Indiana | |
| Fort Wayne Medical Oncology and Hematology, Incorporated | |
| Fort Wayne, Indiana, United States, 46885-5099 | |
| Michiana Hematology-Oncology, P.C. - South Bend | |
| South Bend, Indiana, United States, 46601 | |
| United States, Michigan | |
| Oncology Care Associates, P.L.L.C. | |
| Saint Joseph, Michigan, United States, 49085 | |
| Study Chair: | Hedy L. Kindler, MD | University of Chicago |
More Information
| Study ID Numbers: | CDR0000068878, UCCRC-11045, NCI-3656 |
| Study First Received: | September 13, 2001 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00023946 History of Changes |
| Health Authority: | United States: Federal Government |
|
localized resectable adult primary liver cancer localized unresectable adult primary liver cancer advanced adult primary liver cancer recurrent adult primary liver cancer localized gallbladder cancer unresectable gallbladder cancer recurrent gallbladder cancer |
localized extrahepatic bile duct cancer unresectable extrahepatic bile duct cancer recurrent 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 Epothilone B Liver Diseases Biliary Tract Neoplasms Digestive System Neoplasms Carcinoma, Hepatocellular Epothilones Bile Duct Cancer, Extrahepatic Recurrence |
Carcinoma Liver Neoplasms Gall Bladder Cancer Digestive System Diseases Bile Duct Diseases Biliary Tract Diseases Gastrointestinal Neoplasms 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 |