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Phase I/II Trial of the Addition of PD 0332991 to Cetuximab in Patients with Incurable SCCHN

Status
Active
Cancer Type
Head and Neck Cancer
Oral Cancer
Trial Phase
Phase I
Phase II
Eligibility
18 and over, Male and Female
Study Type
Treatment
NCD ID
NCT02101034
Protocol IDs
201404139 (primary)
NCI-2014-01079
14-X031
Study Sponsor
Siteman Cancer Center at Washington University

Summary

This phase I/II trial studies the side effects and best dose of palbociclib when given together with cetuximab and to see how well they work in treating patients with squamous cell carcinoma of the head and neck that has spread to other parts of the body or has returned and cannot be removed by surgery. Palbociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as cetuximab, may block tumor growth in different ways by targeting certain cells. Giving palbociclib and cetuximab may work better in treating patients with squamous cell carcinoma of the head and neck.

Objectives

PRIMARY OBJECTIVES:

I. To determine the maximum tolerated dose of PD 0332991 (palbociclib) when administered in combination with cetuximab to patients with incurable squamous cell carcinoma of the head and neck (SCCHN). (Phase I)

II. To determine the efficacy of PD 0332991 in combination with cetuximab in incurable platin-resistant human papilloma virus (HPV)-unrelated SCCHN. (Phase II, arm 1)

III. To determine the efficacy of PD 0332991 in combination with cetuximab in incurable cetuximab-resistant HPV-unrelated SCCHN. (Phase II, arm 2)

SECONDARY OBJECTIVES:

I. To assess the adverse events of PD 0332991 in combination with cetuximab. (Phase I and II, arms 1 and 2)

II. To assess the progression-free survival (PFS) of patients with incurable HPV-unrelated SCHNN treated with PD 0332991 in combination with cetuximab. (Phase II, arms 1 and 2)

III. To assess the overall survival (OS) of patients with incurable HPV-unrelated SCHNN treated with PD 0332991 in combination with cetuximab. (Phase II, arms 1 and 2)

IV. To assess duration of response/stable disease of patients with incurable HPV-unrelated SCHNN treated with PD 0332991 in combination with cetuximab. (Phase II, arms 1 and 2)

TERTIARY OBJECTIVES:

I. To document changes in cyclin-dependent kinase inhibitor 2A (p16) expression, Ki-67 (immunohistochemistry [IHC]), phosphorylated (phospho)-retinoblastoma (Rb) (IHC), cyclin D1 (IHC), and apoptosis (terminal deoxynucleotidyl transferase dUTP nick end labeling [TUNEL] assay) after cetuximab and PD 0332991. (Phase II)

II. To monitor quality of life as documented by quality of life (QOL) measurements from the Functional Assessment of Cancer Therapy Head and Neck (FACT H&N) and European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30).

OUTLINE: This is a phase I, dose-escalation study of palbociclib followed by a phase II study. In phase II, patients with platin-resistant disease are assigned to arm 1 and patients with cetuximab-resistant disease are assigned to arm 2.

Patients receive palbociclib orally (PO) once daily (QD) on days 1-21 and cetuximab intravenously (IV) on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 2 months for 5 years.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University


1365 Clifton Road NE
Building C
Atlanta, GA 30322
404-778-5180
winshipcancer.emory.edu

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