BMS-247550 in Treating Patients With Liver or Gallbladder Cancer

May 13, 2014 updated by: National Cancer Institute (NCI)

A Phase II Trial Of The Epothilone B Analog BMS-247550 (NSC 710428D) In Patients With Hepatobiliary Cancer

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment (ixabepilone)
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.
Other: laboratory biomarker analysis
Correlative studies
Drug: ixabepilone
Given IV
Other Names:
  • BMS-247550
  • epothilone B lactam
  • Ixempra

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective response rate (partial or complete response) evaluated by RECIST
Time Frame: Up to 8 years
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
Time Frame: Up to 8 years
Up to 8 years
Time to disease progression
Time Frame: From the first day of treatment until the date PD or death is first reported, assessed up to 8 years
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
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute (NCI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2001

Primary Completion (Actual)

July 1, 2005

Study Completion (Actual)

November 1, 2009

Study Registration Dates

First Submitted

September 13, 2001

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

May 14, 2014

Last Update Submitted That Met QC Criteria

May 13, 2014

Last Verified

December 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCI-2012-02407 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • N01CM62201 (U.S. NIH Grant/Contract)
  • P30CA014599 (U.S. NIH Grant/Contract)
  • 3656 (Other Identifier: CTEP)
  • CDR0000068878
  • NCI-3656
  • UCCRC-11045
  • UC#11045A (Other Identifier: University of Chicago)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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