NL-OMON43772已完成不适用
Olaparib dose escalation trial in patients treated with radiotherapy for laryngeal and oropharyngeal squamous cell carcinoma - Olaparib and radiotherapy in Head and Neck cancer
ederlands Kanker Instituut0 个研究点目标入组 36 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. >=18 years of age
- •2. Histologically confirmed squamous cell carcinoma of the larynx (T2N0M0 or T1-2N1-2bM0 or T3N0-2bM0 or patients with locally advanced disease who will not receive concurrent chemotherapy) or histologically confirmed squamous cell carcinoma of the oropharynx (T1-2N1-2bM0 or T3N0-2bM0 or patients with locally advanced disease who will not receive concurrent chemotherapy)
- •3. In case of oropharyngeal carcinoma: tumor HPV status negative, or history of smoking >= 10 pack years
- •4. WHO performance 0-1
- •5. Life expectancy of at least 6 months
- •6. Adequate hematological, renal and hepatic functions
- •a. Hemoglobin >= 6.2 mmol/L
- •b. Leucocytes >= 3.0 x 10E9/L
- •c. Absolute neutrophil count >= 1.5x10E9/L
- •d. Platelet count >= 100 x 10E9/L
- •e. Total bilirubin <= 1.5 x UNL
- •f. ASAT/ALAT <= 2.5 x UNL
- •g. Creatinine clearance >= 50 ml/min; measured using a 24-hours urine sample or calculated using the Cockcroft-Gault formula
- •7. Evidence of non-childbearing status for women of childbearing potential: negative urine or serum pregnancy test within 21 days of study treatment. Non-childbearing potential or postmenopausal is defined as:
- •Amenorrheic for 1 year or more following cessation of exogenous hormonal treatments
- •LH and FSH levels in post menopausal range for women under 50 years of age
- •Radiation-induced oophorectomy with last menses > 1 year ago
- •Chemotherapy-induced menopause with > 1 year interval since last menses
- •Surgical sterilisation (bilateral oophorectomy or hysterectomy)
- •8. Patients of reproductive potential must agree to practice two effective medically approved contraceptive method during the trial and 3 months afterwards
- •9. Signed written informed consent.
排除标准
- •1. Concurrent active malignancy other than localized, non-melanoma skin cancer or carcinoma-in-situ of the cervix (unless definitive treatment was completed 3 years or more before study entry and the patient has remained disease free)
- •2. Anti-cancer therapy including chemotherapy, radiotherapy, endocrine therapy, immunotherapy or use of other investigational agents within the 3 weeks prior to start of therapy (or a longer period depending on the defined characteristics of the agents used e.g. 6 weeks for mitomycin or nitrosourea). Patients may continue the use of LHRH agonists for cancer; bisphosphonates for bone disease and corticosteroids.
- •3. Major surgery within two weeks of starting study treatment.
- •4. Participation in other trial with investigational drug or treatment modality
- •5. Gastrointestinal disorders that may interfere with absorption of the study drug or patients who are not able to take oral medication.
- •6. Tube feeding before the start of treatment.
- •7. Prior radiotherapy to head & neck region.
- •8. Blood transfusion in the four weeks prior to study entry
- •9. Persistent toxicities (CTC >= grade 2) with the exception of alopecia, caused by previous cancer therapy
- •10. QT-interval >470 msec
- •11. Significant cardiovascular disease as defined by:
- •a. History of congestive heart failure defined as NYHA class III
- •b. History of unstable angina pectoris or myocardial infarction up to 3 months prior to trial entry;
- •c. Presence of severe valvular heart disease
- •d. Presence of a ventricular arrhythmia requiring treatment;
- •e. Uncontrolled hypertension
- •12. Patients considered a poor medical risk due to:
- •a. non-malignant systemic disease
- •b. active, uncontrolled infection requiring parenteral antibiotics
- •c. a serious, uncontrolled medical disorder; examples include, but are not limited to:
- •i. uncontrolled major seizure disorder
- •ii. unstable spinal cord compression
- •iii. superior vena cava syndrome
- •iv. extensive bilateral lung disease on HRCT scan
- •v. any psychiatric disorder that prohibits obtaining informed consent.
- •13. Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
- •14. Patients who are known to be serologically positive for human immunodeficiency virus (HIV) and are receiving antiviral therapy.
- •15. Patients with known active hepatic disease (i.e. Hepatitis B or C)
- •16. Patients with myelodysplastic syndrome/acute myeloid leukaemia or features suggestive of MDS/AML on peripheral blood smear.
- •17. Concomitant medications:
- •a. Any previous treatment with a PARP inhibitor, including olaparib
- •b. Patients receiving the following classes of inhibitors of CYP3A4 (see paragraph 6.4.2 for guidelines and wash out periods)
- •- Azole antifungals
- •- Macrolide antibiotics
- •- Protease inhibitors
- •18. Breast-feeding women
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