BMS-247550 in Treating Patients With Liver or Gallbladder Cancer
Adult Primary Cholangiocellular Carcinoma, Adult Primary Hepatocellular Carcinoma, Advanced Adult Primary Liver Cancer
About this trial
This is an interventional treatment trial for Adult Primary Cholangiocellular Carcinoma
Eligibility 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
Sites / Locations
- University of Chicago
Arms of the Study
Arm 1
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.