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

Exclusion Criteria:

Patients who have had cytotoxic anticancer chemotherapy or immune checkpoint inhibitor within 4 weeks (6 weeks for nitrosoureas or mitomycin C) or palliative radiation within 2 weeks (stereotactic radiation therapy [SRS] for brain metastasis within 48 hours) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
Patients receiving cytotoxic agent as immunomodulatory therapy for a non neoplastic indication (e.g. methotrexate for rheumatoid arthritis) and who are unable to discontinue such agents within 2 weeks prior to starting treatment
Oral targeted therapy within five days or five half-lives, whichever is longer, prior to initiating protocol therapy treatment
Patients who are receiving any other investigational agents
Use of strong cytochrome P450, family 3, subfamily A (CYP3A) inhibitors and inducers
Patients with symptomatic uncontrolled brain metastases are excluded; (patients with stable treated or asymptomatic untreated brain metastasis not requiring glucocorticoids are allowed)
History of allergic reactions attributed to compounds of similar chemical or biologic composition to palbociclib, carboplatin or cisplatin
Concurrent administration of strong inducers and inhibitors of CYP3A enzyme or CYP3A substrates with narrow therapeutic window

Uncontrolled intercurrent illness including, but not limited to:

Ongoing or active infection requiring intravenous antibiotics at the time of treatment initiation
Symptomatic congestive heart failure (requiring hospital stay within the last 6 months)
Myocardial infarction within the last 6 months
Unstable angina pectoris, cardiac arrhythmia
Psychiatric illness
Social situations or circumstances that would limit compliance with study requirements
Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with palbociclib
Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible