NCT03028766

WEE1 Inhibitor with Cisplatin and Radiotherapy: a Trial in Head and Neck Cancer

A Phase I Trial of WEE1 Inhibition with Chemotherapy and Radiotherapy As Adjuvant Treatment, and a Window of Opportunity Trial with Cisplatin in Patients with Head and Neck Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: University of Birmingham · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This trial is to determine what dose of a drug called AZD1775 can safely be given in combination with cisplatin before surgery and with chemo-radiotherapy after surgery in patients with Head and Neck Cancer. The Investigators will also get some preliminary information regarding the effectiveness of this combined treatment.

Detailed description

Patients with head and neck cancer with high-risk features are at increased risk of relapse after surgery. Surgery, often followed by cisplatin chemotherapy and radiotherapy is currently the standard treatment offered. Whilst chemo-radiotherapy improves cure rates, outcomes remain poor, and treatment has a significant impact on quality of life. Chemotherapy has yet to find a definitive role prior to surgery. There is therefore an urgent need to develop more effective treatments which improve cure rates for this patient population. The purpose of this trial is to see whether incorporating a drug called AZD1775 into the management of head and neck cancer offers the possibility of addressing these clinical issues. AZD1775 is a drug that has been shown to increase the effect of cisplatin and of radiotherapy when tested in the laboratory. The blood samples and tumour biopsies taken during the trial will be important in learning as much as possible about the effects of AZD1775 on the body and to investigate how the tumour might develop resistance to the drug. The WISTERIA trial is for patients aged between 18 and 70 years with cancer of the oral cavity, larynx and hypopharynx who are to undergo surgery. Patients recruited to Group A must have accessible tumours for re-biopsy, whilst patients recruited to Group B will be at high risk of relapse after surgery. The primary objective of this trial is to see what dose of AZD1775 can safely be given in combination with cisplatin before surgery (Group A) and with chemo-radiotherapy after surgery (Group B). The Investigators will also get some preliminary information regarding the effectiveness of this combined treatment. To find the safe and effective dose of AZD1775, different doses will be tested for each Group.

Conditions

• Hypopharynx Squamous Cell Carcinoma
• Oral Cavity Squamous Cell Carcinoma
• Larynx Cancer

Interventions

Type	Name	Description
DRUG	AZD1775	AZD1775 is a potent, selective small molecule inhibitor of WEE1
DRUG	Cisplatin	Chemotherapy drug
RADIATION	Radiotherapy	Intensity Modulated Radiotherapy

Timeline

• Start date: 2017-06-22
• Primary completion: 2019-10-31
• Completion: 2021-02-03
• First posted: 2017-01-23
• Last updated: 2024-09-19

Locations

6 sites across 1 country: United Kingdom