Clinical Trials /

Safety And Efficacy Study Of Palbociclib Plus Cetuximab Versus Cetuximab To Treat Head And Neck Cancer

NCT02499120

Description:

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.

Related Conditions:
  • Head and Neck Squamous Cell Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 2

Trial Eligibility

Document

Safety And Efficacy Study Of <span class="go-doc-concept go-doc-intervention">Palbociclib</span> Plus <span class="go-doc-concept go-doc-intervention">Cetuximab</span> Versus <span class="go-doc-concept go-doc-intervention">Cetuximab</span> To Treat Head And Neck Cancer

Title

  • Brief Title: Safety And Efficacy Study Of Palbociclib Plus Cetuximab Versus Cetuximab To Treat Head And Neck Cancer
  • Official Title: A Randomized, Multicenter, Double-Blind Phase 2 Study Of Palbociclib Plus Cetuximab Versus Cetuximab For The Treatment Of Human Papillomavirus-Negative, Cetuximab-Nave Patients With Recurrent/Metastatic Squamous Cell Carcinoma Of The Head And Neck After Failure Of One Prior Platinum-Containing Chemotherapy Regimen
  • Clinical Trial IDs

    NCT ID: NCT02499120

    ORG ID: A5481044

    NCI ID: 2015-000515-41

    Trial Conditions

    Squamous Cell Carcinoma of the Head and Neck (SCCHN)

    Trial Interventions

    Drug Synonyms Arms
    palbociclib IBRANCE, PD-0332991 Palbociclib plus Cetuximab
    Cetuximab ERBITUX Palbociclib plus Cetuximab, Placebo plus Cetuximab
    Placebo Placebo plus Cetuximab

    Trial Purpose

    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.

    Detailed Description

    Trial Arms

    Name Type Description Interventions
    Palbociclib plus Cetuximab Experimental Palbociclib, 125 mg, orally once daily (QD) with food on Day 1 to Day 21 followed by 7 days off treatment in a 28-day cycle; in combination with Cetuximab, 400 mg/m2 initial dose as a 120-minute IV infusion followed by 250 mg/m2 weekly infused over 60 minutes. palbociclib, Cetuximab
    Placebo plus Cetuximab Active Comparator Placebo orally QD with food on Day 1 to Day 21 followed by 7 days off treatment in a 28-day cycle; in combination with Cetuximab, 400 mg/m2 initial dose as a 120-minute IV infusion followed by 250 mg/m2 weekly infused over 60 minutes. Cetuximab, Placebo

    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 or requirement for a feeding tube.

    - Prior use of cetuximab in the R/M disease treatment setting (except cetuximab during
    curative radiotherapy)

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: N/A

    Eligible Gender: Both

    Primary Outcome Measures

    Overall Survival (OS)

    Secondary Outcome Measures

    Patient-Reported Outcome (PRO) measures, EORTC QLQ-C30, between the treatment arms

    Progression-free survival measure of efficacy between the treatment arms

    Correlations between baseline biomarker (eg, p16, Rb) expression in tumor tissue and clinical efficacy in both treatment arms

    Steady state trough concentrations for palbociclib, and trough and maximum concentrations for cetuximab in patients with R/M SCCHN

    Duration of response measure of efficacy between the treatment arms

    Objective response measure of efficacy between the treatment arms

    Patient-Reported Outcome (PRO) measures, EORTC QLQ-H&N35, between the treatment arms

    Trial Keywords

    palbociclib, cetuximab, human papillomavirus, squamous cell carcinoma, head and neck cancer