Cisplatin With or Without WEE1 Inhibitor MK-1775 in Treating Patients With Recurrent or Metastatic Head and Neck Cancer
Condition: 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
MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Carcinoma, Verrucous; Squamous Cell Carcinoma of Head and Neck; Recurrence
Intervention: Cisplatin; Laboratory Biomarker Analysis; Pharmacological Study; Placebo; WEE1 Inhibitor AZD1775
Intervention description: Given IV; Correlative studies; Correlative studies; Given PO; Given PO
Intervention MeSH terms: Cisplatin; Adavosertib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 6.0
Sex: All
Minimum age: 19 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have histologically or cytologically confirmed SCCHN that is recurrent
             and/or metastatic and not amendable to curative therapy by surgery or radiation; SCCHN
             originating from the following sites are eligible: oral cavity, oropharynx, larynx,
             hypopharynx and paranasal sinus; for patients with a diagnosis of SCCHN of unknown
             origin, their eligibility must be reviewed and approved by the principal investigator

          -  No prior systemic chemotherapy or WEE1 kinase inhibitor therapy for metastatic or
             recurrent disease will be allowed; patients are permitted to have received prior
             systemic chemotherapy as a part of the initial multimodality treatment for locally
             advanced disease if this treatment was completed more than 6 months prior to
             enrollment

          -  Patients must have disease amenable to biopsy and must be medically fit to undergo a
             biopsy

          -  Patients must have measurable disease, defined as at least one lesion that can be
             accurately measured in at least one dimension (longest diameter to be recorded) as >
             10 mm with computed tomography (CT) scan; indicator lesions must not have been
             previously treated with surgery, radiation therapy or radiofrequency ablation unless
             there is documented progression after therapy

          -  Patients must have completed any previous surgery or radiotherapy >= 4 weeks prior to
             enrollment

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0-2 (Karnofsky > 60%)

          -  Life expectancy of greater than 12 weeks

          -  Leukocytes >= 3,000/mcL

          -  Absolute neutrophil count >= 1,500/mcL

          -  Platelets >= 100,000/mcL

          -  Hemoglobin >= 9 g/dL

          -  Total bilirubin within normal institutional limits

          -  Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase
             [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT])
             =< 2.5 × institutional upper limit of normal

          -  Prothrombin time (PT)/partial thromboplastin time (PTT)/international normalized ratio
             (INR) =< 1.5 upper limit of normal (ULN)

          -  Creatinine within normal institutional limits OR calculated creatinine clearance >= 60
             mL/min/1.73 m^2 for patients with levels above institutional normal using modified
             Cockcroft-Gault

          -  Cardiac function: 12-lead electrocardiogram (ECG) with normal tracing, or
             non-clinically significant changes that do not require medical intervention; corrected
             QT (QTc) interval is to be < 470 msec

          -  Women of childbearing potential and men must be surgically sterilized, practicing
             abstinence, or agree to use 2 birth control methods prior to study entry and for the
             duration of study participation including up to 30 days after the last dose of
             MK-1775; the 2 methods of birth control can be either 2 barrier methods or a barrier
             method plus a hormonal method to prevent pregnancy; the following are considered
             adequate barrier methods of contraception: diaphragm or sponge, and condom; other
             methods of contraception such as copper intrauterine device or spermicide may be used;
             appropriate hormonal contraceptives will include any registered and marketed
             contraceptive agent that contains an estrogen and/or a progestational agent (including
             oral, subcutaneous, intrauterine, or intramuscular agents); should a woman become
             pregnant or suspect she is pregnant while participating in this study, she should
             inform her treating physician immediately

          -  Ability to understand and the willingness to sign a written informed consent document

        Exclusion Criteria:

          -  Past or current malignancy other than SCCHN, except for:

               -  Cervical carcinoma stage 1B or less

               -  Non-invasive basal cell and squamous cell skin carcinoma

               -  Malignant melanoma with a complete response of a duration of > 10 years

               -  Radically treated prostate cancer (prostatectomy or radiotherapy) with normal
                  prostate specific antigen (PSA), and not requiring ongoing anti-androgen hormonal
                  therapy

               -  Other cancer diagnosis with a complete response of duration of > 5 years

          -  Patients may not be receiving any other investigational agents

          -  Patients with known brain metastases should be excluded from this clinical trial

          -  History of allergic reactions attributed to compounds of similar chemical or biologic
             composition to MK-1775 or cisplatin

          -  Patients who are unable to take oral medications and/or who have a clinical or
             radiological diagnosis of bowel obstruction are ineligible

          -  Uncontrolled intercurrent illness including, but not limited to ongoing or active
             infection, active peptic ulcer disease, myocardial infarction within 6 months prior to
             entry, congestive heart failure, symptomatic congestive heart failure, active
             cardiomyopathy, unstable angina pectoris, cardiac arrhythmia, uncontrolled
             hypertension or psychiatric illness/social situations that would limit compliance with
             study requirements

          -  Pregnant women are excluded from this study; breastfeeding should be discontinued if
             the mother is treated with MK-1775

          -  Human immunodeficiency virus (HIV)-positive patients are ineligible

          -  Patients taking the following prescription or non-prescription drugs or other products
             (i.e. grapefruit juice) are ineligible: sensitive cytochrome P450, family 3, subfamily
             A, polypeptide 4 (CYP3A4) substrates, CYP3A4 substrates with a narrow therapeutic
             index, moderate to potent inhibitors/inducers of CYP3A4; patients would be eligible if
             the medications can be discontinued two weeks prior to day 1 of dosing and withheld
             throughout the study until 2 weeks after the last dose of study medication