Phase I/II study of combined treatment with AT-101, cisplatin and radiotherapy in patients with locally advanced head and neck cancer - AT-101, cisplatin and radiotherapy in head and neck cancer

Antoni van Leeuwenhoek Ziekenhuis0 个研究点目标入组 50 人开始时间: 待定最近更新: 2024年5月6日

适应症

试验速览

暂无简介。

•Histologically proven squamous cell carcinoma of the head and neck
•Oral cavity, oropharyngeal, or hypopharyngeal carcinoma
•Inoperable TNM stage III/IV, M0
•Patient must have measurable disease
•Age > 18 years
•Performance status WHO 0-2
•No prior r adiation therapy to head and neck region
•No prior cisplatin-based chemotherapy
•Adequate laboratory results:
•- WBC > 4.0 x 10E9/l
•- platelets > 100 x 10E9/l
•- calculated or 24 hour creatinine clearance > 50 ml/min
•- ASAT/ALAT < 2.5 times upper limit of normal range
•- Bilirubin < 1.5 x upper limit of institution's normal range
•Willingness to use contraception by a method that is deemed effective by the Investigator throughout the treatment period and for at least 30 days following the last dose of therapy
•Willing and able to undergo blood sampling for pharmacokinetics
•Signed written informed consent before entry into study.
•Entry criteria for translational research:
•- Willing and able to undergo blood sampling, harvesting of buccal smears and tumor biopsy (mandatory)
•- Willing and able to undergo skin biopsy and nuclear scanning (optional)

•Breast feeding or pregnancy
•Uncontrolled arrhythmia
•Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel, ulcerative colitis, inflammatory bowel disease, or partial or complete small bowel obstruction
•Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification.
•Known active symptomatic fungal, bacterial and/or viral infection including active HIV
•Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule

发起方

Antoni van Leeuwenhoek Ziekenhuis