Phase II Trial Evaluating the Efficacy of Palbociclib in Combination With Carboplatin for the Treatment of Unresectable Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

Exclusion Criteria

• •Previous treatment with cytotoxic chemotherapy therapy in the recurrent/metastatic setting. Previous treatment with non-cytotoxic agents in the recurrent/metastatic setting is permitted. Gastrointestinal abnormalities causing impaired absorption precluding administration of oral medications.
• •Evidence of untreated or progressive brain metastases, spinal cord compression, or carcinomatous meningitis.
• •A serious uncontrolled medical disorder or active infection that would impair their ability to receive study treatment.
• •Dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent and compliance with the requirements of this protocol.
• •Patients (male and female) having procreative potential who are not willing or not able to use adequate contraception. Women who are pregnant or breast-feeding.
• •Patients residing in prison.
• •Prior experimental therapy within 30 days of enrollment.
• •Availability of curative treatment option for the patient's cancer, whether surgery, chemotherapy, radiation, or combination thereof, unless the patient has documented refusal of curative treatment.
• •Current use or anticipated inability to avoid use of drugs that are known strong CYP3A4/5 inhibitors (atazanavir, boceprevir, conivaptan, clarithromycin, grapefruit or grapefruit juice, indinavir, itraconazole, ketoconazole, nelfinavir, nefazodone, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, voriconazole ).
• •Current use or anticipated inability to avoid use of drugs that are known strong CYP3A4/5 inducers (carbamazepine, dexamethasone, fosphenytoin, phenytoin, phenobarbital, rifabutin, rifampin, rifapentine, St. John's wort).
• •Patients with a history of severe allergic reaction to cisplatin or carboplatin