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
8 other identifiers
interventional
50
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Aug 2001
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2001
CompletedFirst Submitted
Initial submission to the registry
September 13, 2001
CompletedFirst Posted
Study publicly available on registry
January 27, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2009
CompletedMay 14, 2014
December 1, 2012
3.9 years
September 13, 2001
May 13, 2014
Conditions
Outcome Measures
Primary Outcomes (4)
Objective response rate (partial or complete response) evaluated by RECIST
A 10% response rate precludes further study whereas a 25% response rate would indicate that further study is warranted.
Up to 8 years
Frequency and extent of cytotoxic activity graded according to the NCI CTC Version 2.0
Up to 8 years
Time to disease progression
Will also be evaluated using the Kaplan-Meier estimator.
From the first day of treatment until the date PD or death is first reported, assessed up to 8 years
Overall survival
Will also be evaluated using the Kaplan-Meier estimator.
From the time measurement criteria are met for CR/PR (whichever is first recorded) until the first date that PD is objectively documented, assessed up to 10 years
Study Arms (1)
Treatment (ixabepilone)
EXPERIMENTALPatients 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.
Interventions
Given IV
Eligibility Criteria
You may qualify if:
- Histologically or cytologically confirmed locally advanced, metastatic, or recurrent hepatobiliary cancer
- Liver (hepatocellular)
- Bile duct (cholangiocarcinoma)
- Gallbladder
- At least 1 unidimensionally measurable lesion
- At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
- The following are not considered measurable lesions:
- Lesions seen on colonoscopic examination or barium studies
- Bone metastases
- CNS lesions
- Ascites
- No brain metastases
- Performance status - ECOG 0-2
- At least 3 months
- WBC at least 3,000/mm\^3
- +29 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Chicago
Chicago, Illinois, 60637, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hedy Kindler
University of Chicago
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 13, 2001
First Posted
January 27, 2003
Study Start
August 1, 2001
Primary Completion
July 1, 2005
Study Completion
November 1, 2009
Last Updated
May 14, 2014
Record last verified: 2012-12