Clinical trial NCT02196168
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
Sponsor: National Cancer Institute (NCI)
Start date: 2014-03-01; Completion date: 2016-04-01
Enrollment: 6 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief 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.

Detailed description:
PRIMARY OBJECTIVES:

I. To compare the overall response rate assess the efficacy of MK-1775 (WEE1 inhibitor MK-1775) in combination with cisplatin to cisplatin alone in patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) as per overall response rate (using Response Evaluation Criteria in Solid Tumors \[RECIST\] criteria version \[v\]1.1).

SECONDARY OBJECTIVES:

I. Assess secondary measures of efficacy (progression free survival at 6 months and 12 months, overall survival rate at 12 months).

II. Assess measures of efficacy by tumor protein (p)53 status. III. Evaluate safety and tolerability. IV. Explore predictive and pharmacodynamic biomarkers.

OUTLINE:

SAFETY RUN-IN: Patients receive WEE1 inhibitor MK-1775 orally (PO) twice daily (BID) for 5 doses beginning on day 1 and cisplatin intravenously (IV) over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive WEE1 inhibitor MK-1775 PO BID for 5 doses beginning on day 1 and cisplatin IV over 1 hour on day 1.

ARM II: Patients receive placebo PO BID for 5 doses beginning on day 1 and cisplatin IV over 2 hour on day 1.

In both arms, courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 30 days and then every 3 months for up to 1 year.

Arms: arm 1: Patients receive WEE1 inhibitor MK-1775 PO BID for 5 doses beginning on day 1 and cisplatin IV over 1 hour on day 1. arm 2: Patients receive placebo PO BID for 5 doses beginning on day 1 and cisplatin IV over 2 hour on day 1.
Interventions: intervention 1: Cisplatin intervention 2: Laboratory Biomarker Analysis intervention 3: Pharmacological Study intervention 4: Placebo intervention 5: WEE1 Inhibitor AZD1775
Intervention descriptions: intervention 1: Given IV intervention 2: Correlative studies intervention 3: Correlative studies intervention 4: Given PO intervention 5: Given PO

Protocol documents: