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.

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