BMS-247550 in Treating Patients With Liver or Gallbladder Cancer

Stopped early · Phase 2

Conditions studied: 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

In brief

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.

Key facts

Study ID

NCT00023946

Run by

National Cancer Institute (NCI)

People needed

50

Starts

2001-08-01

Expected to finish

2009-11-01

Last updated by the study team

2014-05-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• University of Chicago — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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