Phase I/II Study of Combined Treatment with AT-101, Cisplatin and Radiotherapy in Patients with Locally Advanced Head and Neck Cancer

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 50

Inclusion Criteria

•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 (see Appendix B)
•No prior radiation therapy to head and neck region
•No prior cisplatin-based chemotherapy
•Adequate laboratory results:
oWBC > 4.0
oplatelets > 100,000
ocalculated or 24 hour creatinine clearance > 50 ml/min
oASAT/ALAT < 2.5 times upper limit of normal range
oBilirubin < 1.5 x upper limit of institution's normal range
•No uncontrolled arrhythmia
•No breast feeding or pregnancy
•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
•Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
•Entry criteria for translational research:
oWilling and able to undergo blood sampling, harvesting of buccal smears and tumor biopsy (mandatory)
oWilling and able to undergo skin biopsy and nuclear scanning (optional)
•Willing and able to undergo blood sampling for pharmacokinetics
•Signed written informed consent before entry into study.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Patients with malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel are excluded. Subjects with ulcerative colitis, inflammatory bowel disease, or partial or complete small bowel obstruction are also excluded.
•Patients with Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification (see Appendix C) are excluded.
•Patients with known active symptomatic fungal, bacterial and/or viral infection including active HIV are excluded. Note: protocol does not require screening for viruses; however, patients with known active infections are excluded.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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