Phase II Study Evaluating Efficacy and Safety of Everolimus with Letrozole for Management of Advanced (unresectable or metastatic) Non Small Cell Lung Cancer (NSCLC) after Failure of Platinum-Based Treatment

Dept of Medical Oncology, Royal Adelaide Hospital0 个研究点目标入组 20 人开始时间: 2007年4月20日最近更新: 2020年1月13日

适应症

试验速览

暂无简介。

•1. Histologically or cytologically proven diagnosis of non-small cell lung cancer of either gender. 2. Age > 18 years for males. Females should be post-menopausal, which is defined as:• Prior oopherectomy, or • 12 month-history of amenorrhoea, or • FSH (Follicle Stimulating Hormone) and LH (Luteinizing Hormone) in post-menopausal range. There is no upper age limit. 3. performance status = 2.4. Adequate organ function• Hematological- Hb> 90 g/L, Absolute Neutrophil Count = 1.5 x 109/L, platelets = 100 x 109/L.• Liver functions- bilirubin = 2 x upper limit normal (ULN), Aspartate Aminotransferase /Alanine Aminotransferase/ Alkaline Phosphatase = 2.5 x ULN or = 5 x ULN in presence of liver metastases, S. albumin = 30 g/L.• Renal function- Creatinine = 2 ULN, Creatinine clearance > 30 mL/min. 6. Patients should stop any hormonal medication as hormone replacement therapy or progesterone at least one month prior to enrolment. 7. Patients should have at least one measurable lesion by RECIST criteria.

•1. Untreated brain metastases. 2. Patients on strong inhibitor or inducer of isoenzyme CYP3A. 3. Serious co-morbidities such as severe cardiac failure or severe pulmonary compromise or severe and active infections. 4. Uncontrolled diabetes.5.Patients with grade 3 hypercholesterolemia / hypertriglyceridemia or = grade 2 hypercholesterolemia / hypertriglyceridemia with history of coronary artery disease (despite lipid lowering treatment if given)6. Previous treatment with mTOR inhibitors and/or known hypersensitivity to mTOR inhibitors.7. A known history of Human Immunodeficiency Virus or previous seropositivity for the virus.8. Leptomeningeal or uncontrolled brain metastases, including patients who continue to require glucocorticoids or intrathecal chemotherapy for brain or leptomeningeal metastases (documented by lumbar puncture).9. Patients will be excluded if they are on raloxifene or tamoxifen. 10. Patients who have an impairment of gastrointestinal function or who havegastrointestinal disease that may significantly alter the absorption of RAD001 (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome).

发起方

Dept of Medical Oncology, Royal Adelaide Hospital