BMS-247550 in Treating Patients With Liver or Gallbladder Cancer
This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00023946
First received: September 13, 2001
Last updated: December 21, 2012
Last verified: December 2012
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Purpose
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 | Intervention | 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 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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 |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Objective response rate (partial or complete response) evaluated by RECIST [ Time Frame: Up to 8 years ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]Will also be evaluated using the Kaplan-Meier estimator.
| Enrollment: | 50 |
| Study Start Date: | August 2001 |
| Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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:
Other: laboratory biomarker analysis
Correlative studies
|
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
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00023946
Locations
| United States, Illinois | |
| University of Chicago Comprehensive Cancer Center | |
| Chicago, Illinois, United States, 60637-1470 | |
Sponsors and Collaborators
Investigators
| Principal Investigator: | Hedy Kindler | University of Chicago Comprehensive Cancer Center |
More Information
No publications provided
| Responsible Party: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00023946 History of Changes |
| Other Study ID Numbers: | NCI-2012-02407, UC#11045A, N01CM62201, CDR0000068878 |
| Study First Received: | September 13, 2001 |
| Last Updated: | December 21, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Liver Neoplasms Carcinoma Gallbladder Neoplasms Bile Duct Neoplasms Cholangiocarcinoma Carcinoma, Hepatocellular Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Liver Diseases Biliary Tract Neoplasms |
Biliary Tract Diseases Gallbladder Diseases Bile Duct Diseases Adenocarcinoma Epothilone B Epothilones Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 23, 2013