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
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Condition or disease | Intervention/treatment | Phase |
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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 |
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 (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 |

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.
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Drug: ixabepilone
Given IV
Other Names:
Other: laboratory biomarker analysis Correlative studies |
- 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.
- Frequency and extent of cytotoxic activity graded according to the NCI CTC Version 2.0 [ Time Frame: 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.
- 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.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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Histologically or cytologically confirmed locally advanced, metastatic, or recurrent hepatobiliary cancer
- Liver (hepatocellular)
- Bile duct (cholangiocarcinoma)
- Gallbladder
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At least 1 unidimensionally measurable lesion
- At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
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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

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
United States, Illinois | |
University of Chicago | |
Chicago, Illinois, United States, 60637 |
Principal Investigator: | Hedy Kindler | University of Chicago |
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 |
Carcinoma Carcinoma, Hepatocellular Liver Neoplasms Cholangiocarcinoma Gallbladder Neoplasms Bile Duct Neoplasms Recurrence Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Disease Attributes Pathologic Processes 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 |