NL-OMON33463招募中不适用
Study to investigate the effects of bevacizumab on [11C]docetaxel kinetics in lung tumours using PET-CT - Effect of bevacizumab on [11C]docetaxel kinetics in lung tumours
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
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
- •- Age: 18 years of age or older.
- •- Patients with lung cancer
- •- Patients with a malignant lesion >= 1.5 cm within the chest as measured by Response Evaluation Criteria in Solid Tumors (RECIST).
- •- Life expectancy of at least 12 weeks.
- •- ECOG performance status of 0 - 2.
- •- At least 4 weeks since any prior surgery or radiotherapy. Patients who, in the opinion of the investigator, have fully recovered from surgery in less than 4 weeks may also be considered for the study.
- •- Patients must have recovered (CTC < 1) from acute toxicities of any previous therapy.
- •- Neutrophils > 1.5 x 109/L and platelets > 100 x 109/L.
- •- Serum bilirubin < 1.5 upper limit of normal (ULN), ASAT/ALAT < 2.5 x ULN (in case of liver metastases < 5 x ULN), alkaline phosphatase < 2.5 x ULN.
- •- Serum creatinine < 1.5 ULN or creatinine clearance > 60 ml/min.
- •- Urine dipstick for proteinuria < 2+. Patients discovered to have > 2+ proteinuria on dipstick urinalysis at baseline, should undergo a 24-hour urine collection and must demonstrate < 1 g of protein/24hr.
- •- Normal serum calcium.
- •- Able to comply with study and follow-up procedures.
- •- For all females of childbearing potential a negative pregnancy test must be obtained within 48 hours before starting the study.
- •- Patients with reproductive potential must use effective contraception.
- •- Written Informed Consent.
排除标准
- •- Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous year, severe cardiac arrhythmia requiring medication, hepatic, renal or metabolic disease).
- •- Patients with squamous lung cancer.
- •- Major surgical procedure, or significant traumatic injury within 28 days prior to administration of bevacizumab (patients must have recovered from any major surgery), or anticipation of need for major surgical procedure during the course of the study.
- •- Planned radiotherapy for underlying disease (prior completed radiotherapy treatment allowed).
- •- Serious non-healing wound or ulcer.
- •- Evidence of bleeding diathesis or coagulopathy or history of hemorrhagic disorders.
- •- Presence of a cavitary lesion or evidence of tumour invading or abutting major blood vessels.
- •- Brain metastasis or spinal cord compression that is newly diagnosed and/or has not yet been treated with surgery and/or radiation; previously diagnosed and treated CNS metastases or spinal cord compression is permitted.
- •- Current or recent (within 10 days prior to administration of bevacizumab) ongoing treatment with anticoagulants for therapeutic purposes i.e. except for anticoagulation for maintenance of patency of permanent indwelling IV catheters.
- •- History of > grade 2 haemoptysis (symptomatic and medical intervention indicated).
- •- Ongoing treatment with aspirin (> 325 mg/day) or other medications known to predispose to gastrointestinal ulceration.
- •- Nursing mothers.;- Previous treatment with taxanes or bevacizumab.
- •- Concomitant treatment with other anticancer agents or experimental drugs.
- •- Haemoglobin > 6.0 mmol/l.
- •- Patients having metal implants (e.g. pacemakers).
- •- Due to the fact that docetaxel is a substrate for P-glycoprotein (P-gp), patients using P-gp drugs like digoxin, cyclosporin, amiodarone, steroids, quinidine, colchicine, etoposide, anti-estrogens will be excluded.
- •- Claustrophobia.
研究者
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