Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms

  • Carcinoma
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms
  • Neoplasms, Unknown Primary
  • 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

NCT number NCT02196168
Study type Interventional
Source National Cancer Institute (NCI)
Contact
Status Terminated
Phase Phase 2
Start date March 2014

See also
  Status Clinical Trial Phase
Active, not recruiting NCT03468218 - Pembrolizumab & Cabozantinib in Patients With Head and Neck Squamous Cell Cancer Phase 2
Recruiting NCT04862650 - Cemiplimab, Low-Dose Paclitaxel and Carboplatin for the Treatment of Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck Phase 2
Completed NCT01256385 - Temsirolimus With or Without Cetuximab in Patients With Recurrent and/or Metastatic Head and Neck Cancer Who Did Not Respond to Previous Therapy Phase 2
Completed NCT03032250 - Prepare to Care, A Supported Self-Management Intervention for Head and Neck Cancer CaregiversHead and Neck Cancer N/A
Recruiting NCT04754321 - Combining Immunotherapy Salvage Surgery & IORT Tx Persistent/Recurrent Head & Neck Cancer Phase 1
Terminated NCT02388932 - Stereotactic Body Radiation Therapy in Treating Patients With High Risk Locally Advanced Head and Neck Cancer N/A
Recruiting NCT05063552 - Testing the Use of Investigational Drugs Atezolizumab and/or Bevacizumab With or Without Standard Chemotherapy in the Second-Line Treatment of Advanced-Stage Head and Neck Cancers Phase 2/Phase 3
Recruiting NCT04588038 - NT-I7 for the Treatment of Recurrent Squamous Cell Carcinoma of Head and Neck Undergoing Surgery Phase 1
Active, not recruiting NCT04576091 - Testing the Addition of an Anti-cancer Drug, BAY 1895344, With Radiation Therapy to the Usual Pembrolizumab Treatment for Recurrent Head and Neck Cancer Phase 1
Recruiting NCT05172258 - Testing the Addition of an Anti-cancer Drug, Ipatasertib, to the Usual Immunotherapy Treatment (Pembrolizumab) in Patients With Recurrent or Metastatic Squamous Cell Cancer of the Head and Neck Phase 2
Active, not recruiting NCT02007200 - Soy Isoflavones in Preventing Head and Neck Cancer Recurrence in Patients With Stage I-IV Head and Neck Cancer Undergoing Surgery Phase 2
Completed NCT01064479 - Combination Chemotherapy With or Without Erlotinib Hydrochloride in Treating Patients With Metastatic or Recurrent Squamous Cell Carcinoma of the Head and Neck Phase 2
Completed NCT00458978 - Cediranib Maleate in Treating Patients With Recurrent or Newly Diagnosed Metastatic Head and Neck Cancer Phase 2
Completed NCT01254617 - Lenalidomide and Cetuximab in Treating Patients With Advanced Colorectal Cancer or Head and Neck Cancer Phase 1
Active, not recruiting NCT01267240 - Capecitabine and Vorinostat in Treating Patients With Recurrent and/or Metastatic Head and Neck Cancer Phase 2
Active, not recruiting NCT00588770 - Chemotherapy With or Without Bevacizumab in Treating Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma Phase 3
Recruiting NCT04671667 - Testing What Happens When an Immunotherapy Drug (Pembrolizumab) is Given by Itself Compared to the Usual Treatment of Chemotherapy With Radiation After Surgery for Recurrent Head and Neck Squamous Cell Carcinoma Phase 2
Active, not recruiting NCT00494182 - Sorafenib in Combination With Carboplatin and Paclitaxel in Treating Participants With Metastatic or Recurrent Head and Neck Squamous Cell Cancer Phase 2
Terminated NCT02068157 - Interstitial Photodynamic Therapy in Treating Patients With Recurrent Head and Neck Cancer Phase 2