Palbociclib With Cisplatin or Carboplatin in Advanced Solid Tumors

Inclusion Criteria

• •Patients must have histologically or cytologically confirmed solid organ malignancy
• •Patients enrolled in the expansion cohort must have histologically or cytologically confirmed squamous non-small cell lung cancer (NSCLC), breast or pancreaticobiliary tract cancer
• •Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
• •Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥ 20 mm (≥ 2 cm) with conventional techniques or as ≥ 10 mm (≥ 1 cm) with spiral computed tomography (CT) scan, magnetic resonance imaging (MRI), or calipers by clinical exam
• •Leukocytes ≥ 3,000/mL
• •Absolute neutrophil count ≥ 1,500/mL
• •Platelets ≥ 100,000/mL
• •Hemoglobin ≥ 10 g/dL
• •Total bilirubin ≤ 1.5 × institutional upper limit of normal (except for patients with Gilbert disease)
• •Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\])/ alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) ≤ 2.5 × institutional upper limit of normal (up to 5 X upper limit of normal \[ULN\] for patients with liver metastasis)
• •Creatinine within normal institutional limits OR creatinine clearance ≥ 60 mL/min/1.73 m² for patients with creatinine levels above institutional normal
• •Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately; men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and for 6 months after completion of study drug administration
• •Ability to understand and the willingness to sign a written informed consent document