RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of BMS-247550 in treating patients who have liver or gallbladder cancer.

Condition	Treatment or Intervention	Phase
adult primary liver cancer extrahepatic bile duct cancer Gallbladder Cancer	Drug: ixabepilone  Procedure: chemotherapy	Phase II

Further Study Details: 

OBJECTIVES:

• Determine the objective response rate of patients with hepatobiliary cancer treated with BMS-247550.
• Determine the toxicity of this drug in these patients.
• 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.

PROJECTED ACCRUAL: A total of 21-50 patients will be accrued for this study within 14 months.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

• 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

PATIENT CHARACTERISTICS: Age:

• 18 and over

Performance status:

• ECOG 0-2

Life expectancy:

• At least 3 months

Hematopoietic:

• WBC at least 3,000/mm^3
• Absolute neutrophil count at least 1,500/mm^3
• Platelet count at least 100,000/mm^3

Hepatic:

• Bilirubin no greater than 1.5 mg/dL
• AST/ALT no greater than 2.5 times upper limit of normal

Renal:

• Creatinine no greater than 1.5 mg/dL OR
• Creatinine clearance at least 60 mL/min

Cardiovascular:

• No symptomatic congestive heart failure
• No unstable angina pectoris
• No cardiac arrhythmia

Other:

• 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

PRIOR CONCURRENT THERAPY: Biologic therapy:

• No concurrent immunotherapy

Chemotherapy:

• No prior chemotherapy
• No other concurrent chemotherapy

Endocrine therapy:

• No concurrent hormonal therapy

Radiotherapy:

• No concurrent therapeutic radiotherapy

Surgery:

• Not specified

Other:

• 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

California
      USC/Norris Comprehensive Cancer Center and Hospital, Los Angeles,  California,  90033,  United States; Recruiting
Illinois
      Cardinal Bernardin Cancer Center at Loyola University Medical Center, Maywood,  Illinois,  60153,  United States; Recruiting
      Central Illinois Hematology Oncology Center, Springfield,  Illinois,  62701,  United States; Recruiting
      Decatur Memorial Hospital Cancer Care Institute, Decatur,  Illinois,  62526,  United States; Recruiting
      Evanston Northwestern Health Care - Evanston Hospital, Evanston,  Illinois,  60201-1781,  United States; Recruiting
      Ingalls Cancer Care Center at Ingalls Memorial Hospital, Harvey,  Illinois,  60426,  United States; Recruiting
      La Grange Memorial Hospital, La Grange,  Illinois,  60525,  United States; Recruiting
      Louis A. Weiss Memorial Hospital, Chicago,  Illinois,  60640,  United States; Recruiting
      Oncology/Hematology Associates of Central Illinois, P.C., Peoria,  Illinois,  61615-7828,  United States; Recruiting
      University of Chicago Cancer Research Center, Chicago,  Illinois,  60637-1470,  United States; Recruiting
      University of Illinois Medical Center, Chicago,  Illinois,  60612,  United States; Recruiting
Indiana
      Fort Wayne Medical Oncology and Hematology, Incorporated, Fort Wayne,  Indiana,  46885-5099,  United States; Recruiting
      Michiana Hematology-Oncology, P.C. - South Bend, South Bend,  Indiana,  46601,  United States; Recruiting
Michigan
      Oncology Care Associates, P.L.L.C., Saint Joseph,  Michigan,  49085,  United States; Recruiting

Study chairs or principal investigators

Hedy L. Kindler, MD,  Study Chair,  University of Chicago Cancer Research Center   

Study ID Numbers:  CDR0000068878; UCCRC-11045; NCI-3656; NCT00023946
Record last reviewed:  August 2004
Last Updated:  April 4, 2005
Record first received:  September 13, 2001
ClinicalTrials.gov Identifier:  NCT00023946
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08