Study on Palbociclib and Chemoradiation Therapy for HPV-Unrelated Head and Neck Cancer

Inclusion Criteria

• Diagnosed with specific types of head and neck cancer, such as cancer of the larynx, hypopharynx, or oral cavity, that is not related to HPV.
• Cancer must be at stage III, IVA, or IVB.
• Have measurable tumors that can be tracked using scans or physical exams.
• Be at least 18 years old.
• Have normal bone marrow function, including specific levels of neutrophils, platelets, and hemoglobin.
• Have a QTc interval of less than 500 milliseconds.
• Agree to use effective birth control during the study and for 90 days after treatment.
• Be able to understand and sign a consent form.

Additional Criteria for Cohort 1:

• Have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
• Have adequate organ function, including specific levels of creatinine, bilirubin, and liver enzymes.

Additional Criteria for Cohort 2:

• Have a performance status score of 2, indicating some limitations in activity.
• Have reduced organ function, including specific levels of creatinine, bilirubin, and liver enzymes.

Exclusion Criteria

• Have a diagnosis of certain other types of head and neck cancer or unknown primary cancer.
• Have cancer that is related to HPV.
• Have cancer that has spread to distant parts of the body.
• Have received prior systemic therapy for the current cancer diagnosis.
• Have had another cancer within the last 2 years, except for certain skin cancers or low-risk prostate, thyroid, and cervical cancers.
• Be currently taking other investigational drugs.
• Have taken certain strong medications or foods that affect drug metabolism within 7 days before starting the study.
• Have a history of allergic reactions to similar drugs used in the study.
• Have uncontrolled illnesses, such as active infections or heart problems.
• Have a history of liver cirrhosis or organ transplants.
• Be pregnant or breastfeeding, or not using effective birth control if of childbearing potential.
• Have HIV and be on antiretroviral therapy.
• Have a specific genetic mutation related to retinoblastoma.