Safety And Efficacy Study Of Palbociclib Plus Cetuximab Versus Cetuximab To Treat Head And Neck Cancer
Condition: Squamous Cell Carcinoma of the Head and Neck (SCCHN)
MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck
Intervention: palbociclib; Cetuximab; Placebo
Intervention description: Palbociclib will be supplied as capsules containing 75 mg, 100 mg, or 125 mg equivalents of palbociclib free base. Administered with food on Day 1 to Day 21 followed by 7 days off treatment in a 28-day cycle.; Cetuximab injection for IV infusion will be provided in 100 mg/50 mL, single-use vials, and 200 mg/100 mL, single-use vials. In Japan, cetuximab will be provided in 100 mg/20 mL, single-use vials. Administered, 400 mg/m2 initial dose as a 120-minute IV infusion followed by 250 mg/m2 weekly infused over 60 minutes.; Placebo for palbociclib will be indistinguishable from the palbociclib capsules and will be supplied as capsules matching in size and color the various palbociclib formulations.
Administered with food on Day 1 to Day 21 followed by 7 days off treatment in a 28-day cycle.
Intervention MeSH terms: Cetuximab; Palbociclib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 125.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: palbociclib, cetuximab, human papillomavirus, squamous cell carcinoma, head and neck cancer

Summary:

      The purpose of this study is to determine whether the combination of palbociclib with
      cetuximab is superior to cetuximab in prolonging overall survival in HPV-negative,
      cetuximab-naive patients with recurrent/metastatic squamous cell carcinoma of the head and
      neck.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Histologically or cytologically confirmed squamous cell carcinoma of the oral cavity,
             oropharynx, hypopharynx or larynx, not amenable for salvage surgery or radiotherapy.

          -  Measurable disease as defined per RECIST v. 1.1. Tumor lesions previously irradiated
             or subjected to other locoregional therapy will only be deemed measureable if disease
             progression at the treated site after completion of therapy is clearly documented.

          -  HPV- negative SCCHN tumor as determined per institutional standard (eg, p16 IHC;
             multiplex nucleic acid sequence based amplification [NASBA] or other polymerase chain
             reaction [PCR]-based assays).

          -  Documented progressive disease according to RECIST v1.1 (Appendix 2) following receipt
             of at least 2 cycles of one platinum-containing chemotherapy regimen administered for
             R/M disease (min. 50 mg/m2 for cisplatin, minimum area under the curve [AUC] > 4 for
             carboplatin).

          -  Availability of a tumor tissue specimen (ie, archived formalin fixed paraffin embedded
             tissue [block preferred, or 15 unstained slides]), which will be used for centralized,
             retrospective biomarker analysis. If archived tumor tissue is not available, then a de
             novo biopsy will be required for patient participation.

        Key Exclusion Criteria:

          -  Prior nasopharyngeal cancer, salivary gland or sinus tumors.

          -  More than one chemotherapeutic regimen given for R/M disease. Prior treatment with
             immunotherapy is allowed.

          -  Known active uncontrolled or symptomatic central nervous system (CNS) metastases,
             carcinomatous meningitis, or leptomeningeal disease as indicated by clinical symptoms,
             cerebral edema, and/or progressive growth. Patients with a history of CNS metastases
             or cord compression are eligible if they have been definitively treated with local
             therapy (eg, radiotherapy, stereotactic surgery) and are clinically stable off
             anticonvulsants and steroids for at least 4 weeks before randomization.

          -  Progressive disease within 3 months after completion of curatively intended treatment
             for locoregionally advanced SCCHN.

          -  Difficulty swallowing capsules.

          -  Prior use of cetuximab in the R/M disease treatment setting (except cetuximab during
             curative radiotherapy)