Lapatinib Ditosylate in Treating Patients With Unresectable Liver or Biliary Tract Cancer

Completed · Phase 2

Conditions studied: Adult Primary Hepatocellular Carcinoma, Advanced 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

Lapatinib ditosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. This phase II trial is studying how well lapatinib ditosylate works in treating patients with unresectable liver or biliary tract cancer

Key facts

Study ID

NCT00107536

Run by

National Cancer Institute (NCI)

People needed

26

Starts

2005-10-01

Expected to finish

2009-05-01

Last updated by the study team

2015-04-29

Who can join

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

You may qualify if…

• Histologically confirmed diagnosis of 1 of the following:
• Hepatocellular carcinoma (hepatoma)
• Child-Pugh classification score ≤ 7
• Biliary tract carcinoma
• Surgically unresectable disease
• Measurable disease
• At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
• Fresh tissue or paraffin embedded tissue from tumor blocks available
• No ampulla of Vater tumors
• No known brain metastases
• Performance status - ECOG 0-1
• Performance status - Karnofsky 60-100%
• More than 12 weeks
• Absolute neutrophil count ≥ 1,500/mm\^3
• Platelet count ≥ 75,000/mm\^3
• Bilirubin ≤ 2 times upper limit of normal (ULN)
• AST and ALT ≤ 3 times ULN
• Albumin ≥ 2.5 mg/dL
• INR ≤ 1.5 (for patients not receiving an anticoagulant)
• Live metastases or stable chronic liver disease allowed
• No current active hepatic or biliary disease except for Gilbert's syndrome or asymptomatic gallstone
• Creatinine ≤ 2 mg/dL
• Ejection fraction normal by echocardiogram or MUGA
• No unstable angina pectoris
• No cardiac arrhythmia

Where it is running

• Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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