Cisplatin With or Without WEE1 Inhibitor MK-1775 in Treating Patients With Recurrent or Metastatic Head and Neck Cancer

Summary

This randomized phase II trial studies how well cisplatin with or without WEE1 inhibitor MK-1775 works in treating patients with head and neck cancer that has come back or has spread to other parts of the body. Drugs used in chemotherapy, such as cisplatin, may prevent tumor cells from multiplying by damaging their deoxyribonucleic acid (DNA), which in turn stops the tumor from growing. WEE1 inhibitor MK-1775 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether cisplatin is more effective with or without WEE1 inhibitor MK-1775 in treating patients with head and neck cancer.

Conditions

• Recurrent Hypopharyngeal Squamous Cell Carcinoma
• Recurrent Laryngeal Squamous Cell Carcinoma
• Recurrent Laryngeal Verrucous Carcinoma
• Recurrent Lip and Oral Cavity Squamous Cell Carcinoma
• Recurrent Metastatic Squamous Cell Carcinoma in the Neck With Occult Primary
• Recurrent Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma
• Recurrent Oral Cavity Verrucous Carcinoma
• Recurrent Oropharyngeal Squamous Cell Carcinoma
• Squamous Cell Carcinoma Metastatic in the Neck With Occult Primary
• Stage IV Hypopharyngeal Squamous Cell Carcinoma
• Stage IVA Laryngeal Squamous Cell Carcinoma
• Stage IVA Laryngeal Verrucous Carcinoma
• Stage IVA Lip and Oral Cavity Squamous Cell Carcinoma
• Stage IVA Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma
• Stage IVA Oral Cavity Verrucous Carcinoma
• Stage IVA Oropharyngeal Squamous Cell Carcinoma
• Stage IVB Laryngeal Squamous Cell Carcinoma
• Stage IVB Laryngeal Verrucous Carcinoma
• Stage IVB Lip and Oral Cavity Squamous Cell Carcinoma
• Stage IVB Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma
• Stage IVB Oral Cavity Verrucous Carcinoma
• Stage IVB Oropharyngeal Squamous Cell Carcinoma
• Stage IVC Laryngeal Squamous Cell Carcinoma
• Stage IVC Laryngeal Verrucous Carcinoma
• Stage IVC Lip and Oral Cavity Squamous Cell Carcinoma
• Stage IVC Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma
• Stage IVC Oral Cavity Verrucous Carcinoma
• Stage IVC Oropharyngeal Squamous Cell Carcinoma
• Tongue Carcinoma

Interventions

DRUG

Cisplatin

Given IV

OTHER

Laboratory Biomarker Analysis

Correlative studies

OTHER

Pharmacological Study

Correlative studies

OTHER

Placebo

Given PO

DRUG

WEE1 Inhibitor AZD1775

Given PO

Sponsors & Collaborators

• National Cancer Institute (NCI)

  lead NIH

Principal Investigators

• Eric Winquist · University Health Network Princess Margaret Cancer Center P2C

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

19 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-03-31

Primary Completion

2016-04-30

Completion

2016-04-30

Countries

• Canada

Study Locations