PD-0332991, 5-FU, and Oxaliplatin for Advanced Solid Tumor Malignancies

Inclusion Criteria

• •Retinoblastoma-positive, histologically proven advanced solid tumor malignancies for which no curative therapy exists
• •Biopsy accessible tumor deposits
• •Corrected QT interval less than 500 milliseconds by EKG
• •ECOG preformance status 0-2
• •Subjects with no brain metastases or a history of previously treated brain metastases who have been treated by surgery or stereotactic radiosurgery at least 4 weeks prior to enrollment and have a baseline MRI that shows no evidence of active intracranial disease and have not had treatment with steroids within 1 week of study enrollment.
• •Adequate hepatic, bone marrow, and renal function
• •Partial thromboplastin time must be \</= 1.5 x upper limit normal range and INR \< 1.5. Subjects on anticoagulant will be permitted to enroll as long as the INR is in acceptable therapeutic range.
• •Life expectancy \> 12 weeks
• •Women of childbearing potential must have a negative serum pregnancy test within 14 days prior to initiation of treatment and/or postmenopausal women must be amenorrheic for at least 12 months.
• •Subject is capable of understanding and complying with parameters of the protocol and able to sign and date the informed consent.
• •Peripheral neuropathy \>/= Grade 2 at baseline or peripheral neuropathy \>/= Grade 1 with neuropathic pain
• •Active severe infection or known chronic infection with HIV or hepatitis B virus
• •Cardiovascular disease problems including unstable angina, therapy for life-threatening ventricular arrhythmia or myocardial infarction, stroke, or congestive heart failure within the last 6 months.
• •Life-threatening visceral disease or other severe concurrent disease
• •Women who are pregnant or breastfeeding
• •Anticipated patient survival under 3 months
• •Concurrent use of known CYP 3A4 inhibiting or activating medications
• •Clinically significant and uncontrolled major medical condition(s)