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BMS-247550 in Treating Patients With Liver or Gallbladder Cancer

Primary Purpose

Adult Primary Cholangiocellular Carcinoma, Adult Primary Hepatocellular Carcinoma, Advanced Adult Primary Liver Cancer

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ixabepilone
laboratory biomarker analysis
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adult Primary Cholangiocellular Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Bilirubin no greater than 1.5 mg/dL AST/ALT no greater than 2.5 times upper limit of normal Creatinine no greater than 1.5 mg/dL Creatinine clearance at least 60 mL/min No symptomatic congestive heart failure No unstable angina pectoris No cardiac arrhythmia No grade 2 or greater peripheral neuropathy No other uncontrolled concurrent illness No ongoing or active infection No psychiatric illness or social situation that would preclude study compliance No prior allergic hypersensitivity reaction attributed to compounds containing Cremophor EL (e.g., paclitaxel or compounds of similar chemical or biological composition to BMS-247550) No other currently active malignancy except nonmelanoma skin cancer, carcinoma in situ of the cervix, or cancer for which patient has completed therapy and is at less than 30% risk of relapse Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No concurrent immunotherapy No prior chemotherapy No other concurrent chemotherapy No concurrent hormonal therapy No concurrent therapeutic radiotherapy At least 30 days since prior investigational agents At least 7 days since prior cimetidine No concurrent cimetidine No other concurrent commercial or investigational anticancer agents or therapies No concurrent unconventional therapies, food, or vitamin supplements (e.g., St. John's Wort) No concurrent combination antiretroviral therapy for HIV-positive patients

Sites / Locations

  • University of Chicago

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (ixabepilone)

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
Frequency and extent of cytotoxic activity graded according to the NCI CTC Version 2.0
Time to disease progression
Will also be evaluated using the Kaplan-Meier estimator.
Overall survival
Will also be evaluated using the Kaplan-Meier estimator.

Secondary Outcome Measures

Full Information

First Posted
September 13, 2001
Last Updated
May 13, 2014
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00023946
Brief Title
BMS-247550 in Treating Patients With Liver or Gallbladder Cancer
Official Title
A Phase II Trial Of The Epothilone B Analog BMS-247550 (NSC 710428D) In Patients With Hepatobiliary Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Terminated
Study Start Date
August 2001 (undefined)
Primary Completion Date
July 2005 (Actual)
Study Completion Date
November 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (ixabepilone)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
ixabepilone
Other Intervention Name(s)
BMS-247550, epothilone B lactam, Ixempra
Intervention Description
Given IV
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Description
Correlative studies
Primary Outcome Measure Information:
Title
Objective response rate (partial or complete response) evaluated by RECIST
Description
A 10% response rate precludes further study whereas a 25% response rate would indicate that further study is warranted.
Time Frame
Up to 8 years
Title
Frequency and extent of cytotoxic activity graded according to the NCI CTC Version 2.0
Time Frame
Up to 8 years
Title
Time to disease progression
Description
Will also be evaluated using the Kaplan-Meier estimator.
Time Frame
From the first day of treatment until the date PD or death is first reported, assessed up to 8 years
Title
Overall survival
Description
Will also be evaluated using the Kaplan-Meier estimator.
Time Frame
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Bilirubin no greater than 1.5 mg/dL AST/ALT no greater than 2.5 times upper limit of normal Creatinine no greater than 1.5 mg/dL Creatinine clearance at least 60 mL/min No symptomatic congestive heart failure No unstable angina pectoris No cardiac arrhythmia No grade 2 or greater peripheral neuropathy No other uncontrolled concurrent illness No ongoing or active infection No psychiatric illness or social situation that would preclude study compliance No prior allergic hypersensitivity reaction attributed to compounds containing Cremophor EL (e.g., paclitaxel or compounds of similar chemical or biological composition to BMS-247550) No other currently active malignancy except nonmelanoma skin cancer, carcinoma in situ of the cervix, or cancer for which patient has completed therapy and is at less than 30% risk of relapse Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No concurrent immunotherapy No prior chemotherapy No other concurrent chemotherapy No concurrent hormonal therapy No concurrent therapeutic radiotherapy At least 30 days since prior investigational agents At least 7 days since prior cimetidine No concurrent cimetidine No other concurrent commercial or investigational anticancer agents or therapies No concurrent unconventional therapies, food, or vitamin supplements (e.g., St. John's Wort) No concurrent combination antiretroviral therapy for HIV-positive patients
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hedy Kindler
Organizational Affiliation
University of Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States

12. IPD Sharing Statement

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BMS-247550 in Treating Patients With Liver or Gallbladder Cancer

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