| | Requirement |
| 1 | Histologically or cytologically confirmed surgically unresectable Hepatocellular cancer and who are not candidates for percutaneous ethanol injection or radio frequency ablation (RFA). |
| 2 | Measurable disease per RECIST. If patient had transarterial chemoembolization (TACE), ethanol or RFA ablation, must have new liver lesions if there are no other sites of disease. |
| 3 | No prior systemic chemotherapy. May have had prior TACE, ethanol injection, radiofrequency ablation or cryosurgery; all side effects of prior therapy must have been resolved prior to start of Dasatinib.
|
| 4 | Patients above 18 y/o. |
| 5 | Life expectancy of at least more than 3 months. |
| 6 | ECOG Performance Status 0-1. |
| 7 | Leukocytes more than or equal to 3000; absolute neutrophil count more than or equal to 1500; Platelet count more than or equal to 90,000. |
| 8 | Total bilirubin less than or equal to 2.0 x ULN. |
| 9 | AST and ALT less than or equal to 2.5 x ULN (less than or equal to 5 x ULN if with liver involvement). |
| 10 | Serum creatinine less than or equal to 2.0 x ULN. |
| 11 | Protime less than or equal to 1.5 x ULN. |
| 12 | Serum albumin more than or equal to 2.5 mg/dl. |
| 13 | Signed Informed Consent (including HIPAA authorization). |
| 1 | TACE or radiotherapy w/i 4 wks prior to study entry or failure to recover from toxicities due to agents administered > 4 wks earlier.
Localized palliative radiation (i.e for bony mets, etc) given for < 3 days is allowed before or during treatment & not subject to the 4 wk waiting requirement.
|
| 2 | Receiving other investigational agents.
|
| 3 | Known brain mets.
|
| 4 | History of allergic reactions attributed to compounds of similar chemical or biologic composition to Dasatinib.
|
| 5 | Concurrent treatment with any medications or substances that are potent inhibitors or inducers of CYP3A4.
|
| 6 | QTc prolongation (QTc interval 480 msecs or more) or other clinically significant EKG abnormalities.
|
| 7 | Use of anti-thrombotic &/or anti-platelet agents (e.g. warfarin, heparin, LMWH, aspirin &/or ibuprofen). If medically safe, discontinue 7 days prior to first dose of Dasatinib.
|
| 8 | Any condition that impairs ability to swallow & retain Dasatinib tablets, e.g.: GI tract disease resulting in inability to take oral med or a requirement for IV alimentation, prior surgical procedures affecting absorption, active peptic ulcer disease.
|
| 9 | Any clinically significant cardiovascular disease including the following:
MI or ventricular tachyarrhythmia w/i 6 mos, prolonged QTc 480 msec or more (Fridericia correction), ejection fraction < normal (should be done if clinically indicated & for patients with heart failure on medication), major conduction abnormality (unless with cardiac pacemaker).
|
| 10 | Uncontrolled intercurrent illness including, but not limited to:
ongoing or active infection, history of significant bleeding disorder, including congenital (von Willebrand’s) or acquired (anti-factor VIII antibodies) disorders, psychiatric illness/social situations that would limit protocol compliance.
|
| 11 | Pregnant or nursing women.
|
| 12 | HIV positive, on combination antiretroviral threrapy. |
| 13 | Any degree of pleural effusion or ascites requiring paracentesis within 4 wks of study entry.
|
| 14 | Any evidence of encephalopathy. |
| 15 | Scores that fall into Childs C group of Child-Pugh Criteria. |
