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
Condition: Squamous Cell Carcinoma of the Head and Neck
MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck
Intervention: Palbociclib; Carboplatin
Intervention description: Palbociclib (Ibrance) (PO), dose= 125 mg PO daily, days=1-14, cycle length: 21 days
Maintenance Palbociclib:
Palbociclib (Ibrance) 125 mg PO daily, days 1-21, cycle length: 28 days; Carboplatin (IV), dose= AUC 5, day= 1, cycle length: 21 days
Intervention MeSH terms: Carboplatin; Palbociclib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 21.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to test the effectiveness (how well the drug works), safety, and
      tolerability of the investigational drug combination of palbociclib (Ibrance) plus
      carboplatin in patients with metastatic head and neck squamous cell cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically documented progressive squamous cell head and neck cancer with or
             without metastases, not amenable to curative treatment; or the patient has documented
             refusal of curative treatment.

          -  ECOG performance status of 0-2. Eastern Cooperative Oncology Group Performance Status:
             an attempt to quantify cancer patients' general well-being and activities of daily
             life. The score ranges from 0 to 5 where 0 is asymptomatic and 5 is death.

          -  Presence of measurable disease by CT scan per RECIST v1.1.

          -  Age ≥18 years.

          -  Life expectancy of ≥12 weeks.

          -  Women of childbearing potential must have a negative serum or urine pregnancy test at
             time of screening and confirmed within 3 days prior to treatment. Women not of
             child-bearing potential will be defined as all women older than age 50 and anovulatory
             for 12 months.

          -  Signed and dated informed consent document indicating that the patient (or legally
             acceptable representative) has been informed of all pertinent aspects of the trial
             prior to enrollment.

          -  Willingness and ability to comply with scheduled visits, treatment plans, laboratory
             tests, and other study procedures.

          -  Adequate organ and marrow function

        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