NL-OMON30513尚未招募不适用
Phase I study of Gemcitabine plus Lapatinib (GW572016) in women with advanced breast cancer - N06GLB
Antoni van Leeuwenhoek Ziekenhuis0 个研究点目标入组 25 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
- 尚未招募
- 发起方
- 入组人数
- 25
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
- •All patients who are considered for palliative Gemcitabine chemotherapy for advanced breast cancer.
- •Furthermore:
- •1. > 18 years
- •2. Performance status: WHO 0 - 2
- •3. Life expectancy > 3 months
- •4. Histological or cytological proof of breast cancer
- •5. Evaluable or measurable disease according to RECIST criteria
- •6. Previous chemotherapy with an anthracycline and a taxane.
- •7. Previous Trastuzumab (Herceptin®) in case of Her2/neu overexpression (IHC) or gene amplification (FISH/CISH)
- •8. No radiotherapy for at least 2 weeks prior to study entry
- •9. Minimal acceptable safety laboratory values
- •a. ANC of >= 1.5 × 109/l
- •b. Platelet count of >= 100 × 109/l
- •c. Haemoglobin level of >= 10 g/dl (>= 6.2 mmol/l)
- •(prior transfusion is permitted)
- •d. Hepatic function as defined by serum bilirubin <= 1.5 times the upper limit of normal, ALT and AST <= 2.5 times the upper limit of normal.
- •e. Renal function as defined by serum creatinine <= 1.5 times upper limit of normal or creatinine clearance >= 50 ml/min (by Cockcroft-Gault formula).
- •10. Cardiac ejection fraction (LVEF) within the institutional range of normal as measured by echocardiogram or MUGA scan (i.e. > 50%). Baseline and on treatment scans should be performed using the same modality.
- •11. Able to swallow and retain oral medication
- •12. Written informed consent
排除标准
- •1. More than three previous courses of chemotherapy including adjuvant chemotherapy
- •2. Patients who have received a cumulative dose of adriamycine more than 360 mg/m2 or a cumulative dose of epirubicine more than 600 mg/m2.
- •3. Symptomatic CNS metastases.
- •4. Previous investigational cytotoxic or biological treatment for malignant disease within 30 days before the start of the study.
- •5. Any treatment with non-oncological investigational drugs within 30 days before the start of the study
- •6. Concomitant requirement for medication classified as CYP3A4 inducers or inhibitors.
- •7. Patients using medications or substances known to affect, or with the potential to affect the activity or pharmacokinetics of Lapatinib.
- •8. Treatment within one week before the start of the study with any of the following: terfenadine, cisapride, cyclosporin, tacrolimus, theophylline, diazepam, sulphonylurea hypoglycaemics, phenytoin, or carbamazepine.
- •9. Uncontrolled infections.
- •10. All herbal (alternative) medicines are excluded, but multivitamins are allowed.
- •11. Pregnancy or breast feeding (all women of childbearing potential must have a pregnancy test before inclusion in the study; post-menopausal women must have amenorrhoea for at least 12 months). Female patients must use adequate contraceptive protection.
- •12. HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with Lapatinib.
- •13. Clinically significant cardiac impairment or unstable ischaemic heart disease including a myocardial infarction (< 3 months of study entry)
- •14. History of alcoholism, drug addiction, or any psychiatric or psychological condition which in the opinion of the investigator would impair study compliance
- •15. Malabsorption syndrome or other condition which may affect absorption of Lapatinib.
- •16. Concurrent or previous malignancy of a different tumour type within five years of starting the study except for adequately treated non-melanoma skin cancer or cervical intraepithelial neoplasia
- •17. Patients who have had previous treatment with Lapatinib.
- •18. Legal incapacity
研究者
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