A Clinical Research Study to Determine Whether PD 0332991 May Be Effective in Treating Patients With Liver Cancer

Inclusion Criteria

• Male or female, age > or = 18 years with HCC refractory to currently available therapies.
• Documented HCC by at least 2 out of 3 mentioned criteria and evidence of non-resectability by a multidisciplinary team:

A. Radiological - MRI with arterial enhancement and rapid venous washout B. Biopsy C. Serum alpha-fetoprotein level > or = 200

• Positive staining for RB-function on tumor biopsy.
• Subject must be able to give written informed consent and be able to follow protocol requirements
• Life expectancy greater than 3 months
• Be Child's-Pugh class A or B
• ECOG Performance status of or = 8 g/dL B. WBC > or = 4,000/uL C. Absolute neutrophil count > or = 1,500/uL D. Platelets > or = 75,000/uL E. Total bilirubin or = 2.5 mg/dL
• Subjects who have received previous radiotherapy, loco-regional, or systemic therapy are eligible. A minimum interval of 4 weeks since the last anti-cancer treatment of any kind is required.
• Subjects with brain metastases or a history of previously treated brain metastasis are eligible but must:

A. Have been treated by surgery or stereotactic radiosurgery (SRS) at least 4 weeks prior to enrollment B. AND have a baseline MRI or CT that shows no evidence of active intercranial disease C. AND be off steroids for at least 1 week prior to study enrollment

Exclusion Criteria

• Any concurrent active malignancy requiring treatment (other than basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, superficial bladder tumors, or other malignancies curatively treated > 3 years prior to study entry)
• History of severe cardiovascular disease within the last 12 months: symptomatic congestive heart failure, myocardial infarction, coronary artery disease (CAD), life threatening arrhythmias, uncontrolled hypertension
• Renal failure requiring hemo- or peritoneal dialysis
• Unstable systemic diseases or active uncontrolled infection
• Known history of HIV infection
• Clinically significant gastrointestinal bleeding within 30 days prior to study entry
• Major surgery, open biopsy or significant traumatic injury within 4 weeks prior to study entry
• Child's-Pugh Class C
• Any malabsorption problem that, in the investigator's opinion, would prevent adequate absorption of the study drug
• Presence of any other medical complications that in the investigator's opinion, suggests a survival of < 3 months
• Substance abuse, or medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
• Patient inability to swallow oral medications
• Any condition that is unstable or which could jeopardize the safety of the patient and his/her compliance in the study
• Pregnant or breast-feeding patients
• Being of reproductive potential and unable or unwilling to practice an effective contraceptive method
• Lack of positive staining for RB-function on tumor biopsy.