Trials / Terminated
TerminatedNCT00023946
BMS-247550 in Treating Patients With Liver or Gallbladder Cancer
A Phase II Trial Of The Epothilone B Analog BMS-247550 (NSC 710428D) In Patients With Hepatobiliary Cancer
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 50 (actual)
- Sponsor
- National Cancer Institute (NCI) · NIH
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Phase II trial to study the effectiveness of BMS-247550 in treating patients who have liver or gallbladder cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
Detailed description
PRIMARY OBJECTIVES: I. Determine the objective response rate of patients with hepatobiliary cancer treated with BMS-247550. II. Determine the toxicity of this drug in these patients. III. Determine the duration of response, median and overall survival, and time to progression in patients treated with this drug. 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
Conditions
- Adult Primary Cholangiocellular Carcinoma
- Adult Primary Hepatocellular Carcinoma
- Advanced Adult Primary Liver Cancer
- Cholangiocarcinoma of the Extrahepatic Bile Duct
- Cholangiocarcinoma of the Gallbladder
- Localized Extrahepatic Bile Duct Cancer
- Localized Gallbladder Cancer
- Localized Resectable Adult Primary Liver Cancer
- Localized Unresectable Adult Primary Liver Cancer
- Recurrent Adult Primary Liver Cancer
- Recurrent Extrahepatic Bile Duct Cancer
- Recurrent Gallbladder Cancer
- Unresectable Extrahepatic Bile Duct Cancer
- Unresectable Gallbladder Cancer
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ixabepilone | Given IV |
| OTHER | laboratory biomarker analysis | Correlative studies |
Timeline
- Start date
- 2001-08-01
- Primary completion
- 2005-07-01
- Completion
- 2009-11-01
- First posted
- 2003-01-27
- Last updated
- 2014-05-14
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00023946. Inclusion in this directory is not an endorsement.