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BMS-247550 in Treating Patients With Liver or Gallbladder Cancer

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ClinicalTrials.gov Identifier: NCT00023946
Recruitment Status : Terminated
First Posted : January 27, 2003
Last Update Posted : May 14, 2014
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Description
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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.

Condition or disease Intervention/treatment Phase
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 Drug: ixabepilone Other: laboratory biomarker analysis Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial Of The Epothilone B Analog BMS-247550 (NSC 710428D) In Patients With Hepatobiliary Cancer
Study Start Date : August 2001
Actual Primary Completion Date : July 2005
Actual Study Completion Date : November 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Ixabepilone

Arms and Interventions
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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.
 Drug: ixabepilone
Given IV
Other Names:
  • BMS-247550
  • epothilone B lactam
  • Ixempra

Other: laboratory biomarker analysis
Correlative studies


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. Frequency and extent of cytotoxic activity graded according to the NCI CTC Version 2.0 [ Time Frame: Up to 8 years ]
  3. 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.

  4. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00023946


Locations
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United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Hedy Kindler University of Chicago
More Information
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Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00023946    
Other Study ID Numbers: NCI-2012-02407
NCI-2012-02407 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000068878
NCI-3656
UCCRC-11045
UC#11045A ( Other Identifier: University of Chicago )
3656 ( Other Identifier: CTEP )
P30CA014599 ( U.S. NIH Grant/Contract )
N01CM62201 ( U.S. NIH Grant/Contract )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: May 14, 2014
Last Verified: December 2012
Additional relevant MeSH terms:
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Carcinoma
Liver Neoplasms
Cholangiocarcinoma
Gallbladder Neoplasms
Bile Duct Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
 Liver Diseases
Biliary Tract Neoplasms
Biliary Tract Diseases
Gallbladder Diseases
Bile Duct Diseases
Epothilones
Epothilone B
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents