EUCTR2005-004508-35-GB进行中（未招募）1 期
THE USE OF PET/CT SCANNING TO ASSESS EARLY RESPONDERS TO TARCEVA (ERLOTINIB): A PHASE II STUDY - PET/CT scanning to assess response to Tarceva
Royal Marsden Hospital0 个研究点目标入组 47 人开始时间: 2005年10月14日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 47
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •1.Histologically confirmed diagnosis of stage IIIB/IV NSCLC overexpressing EGFR (i.e =10% membrane staining on tumour cells via Dako IHC kit).
- •2. Patients can receive Tarceva (erlotinib) in first, second or third line settings – situations where Tarceva would be considered appropriate treatment.
- •3.Must have recovered from any treatment related toxicities regardless of regimen prior to registration, except for alopecia, grade1 fatigue, or grade 1 neurotoxicity
- •4. Must have measurable disease via CT criteria
- •5. Age = 18yrs,
- •6. ECOG 0-2 and predicted life expectancy = 12 weeks
- •7. Previous surgery: permitted provided that wound healing has occurred prior to registration
- •8. Adequate haematopoietic, hepatic and renal function defined as follows:
- •·Absolute neutrophil count (ANC) = 1.5 x 109/L and platelet count = 100 x 109/L
- •·Bilirubin within or = 1.5 x ULN, ALT (SGPT) = 2.5 x ULN (or = 5x ULN in cases of liver metastases)
- •·Serum creatinine = 1.5x ULN
- •9.Accessible for repeat dosing and follow-up. Investigators must assure themselves that the patient registered on this trial will be available for complete documentation of the treatment, toxicity, and follow-up.
- •10. Patients who have already had a diagnostic PET/CT at the Royal Marsden Hospital in the previous 4 weeks can be considered for entry into the study in they overexpress EGFR as above and Tarceva is considered appropriate treatment for them. They will be assessed after 6 weeks of treatment by a further PET/CT.
- •11.Patients must provide verbal and written informed consent to participate in the 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
排除标准
- •1. Any concurrent anticancer cytostatic or cytotoxic chemotherapy.
- •2. If the administration of Tarceva to patients receiving concomitant CYP3A4 or CYP1A2 inducers/inhibitors could impact significantly on their clinical care, these patients should be excluded – see appendix 3
- •3. Any other active malignancies unless deemed cured with at least 5 years of follow-up. In situ cervical cancer and in situ/basal cell skin cancer are permitted.
- •4.Active or uncontrolled infections or serious illnesses or medical conditions that could interfere with the patient’s ongoing participation in the study.
- •5.History of psychiatric condition that might impair the patients ability to understand or to comply with the requirements of the study or to provide informed consent
- •6.Gastro-intestinal abnormalities, including inability to take oral medication, requirement for iv alimentation, active peptic ulcer or prior surgical procedures affecting absorption
- •7. Inability to lie flat for the duration of the PET scan (for up to 2 hours).
研究者
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