BMS-247550 in Treating Patients With Liver or Gallbladder Cancer - Full Text View

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:

MedlinePlus related topics: Cancer Liver Cancer

Drug Information available for: Ixabepilone

Genetic and Rare Diseases Information Center resources: Bile Duct Cancer Gall Bladder Cancer Intrahepatic Cholangiocarcinoma Liver Cancer

U.S. FDA Resources

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
Study Completion Date:	November 2009
Primary Completion Date:	July 2005 (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: BMS-247550 epothilone B lactam Ixempra 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00023946

Locations


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

Sponsors and Collaborators

National Cancer Institute (NCI)

Investigators


Principal Investigator:	Hedy Kindler	University of Chicago

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, NCI-2012-02407, CDR0000068878, NCI-3656, UCCRC-11045, UC#11045A, 3656, P30CA014599, N01CM62201
Study First Received:	September 13, 2001
Last Updated:	May 13, 2014
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:


Bile Duct Neoplasms Carcinoma Carcinoma, Hepatocellular Cholangiocarcinoma Gallbladder Neoplasms Liver Neoplasms Adenocarcinoma Bile Duct Diseases Biliary Tract Diseases	Biliary Tract Neoplasms Digestive System Diseases Digestive System Neoplasms Gallbladder Diseases Liver Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on March 03, 2015