KCT0005787进行中（未招募）未知
Pemetrexed in combination with erlotinib as a salvage treatment in patients with metastatic biliary tract cancer (BTC) who failed gemcitabine containing chemotherapy: A phase II single arm prospective study
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 入组人数
- 44
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 0No Limit（—）
- 性别
- All
入选标准
- •? Provide complete subject consent before any test designation procedure
- •? Adults over 19 years old
- •? Progressive metastatic biliary tract cancer that cannot be operated after failing treatment with gemcitabine.
- •-Those who only received primary chemotherapy
- •-Intrahepatic bile duct cancer, extrahepatic bile duct cancer, gallbladder cancer? Patients must have the will and ability to comply with the clinical trial protocol during the trial period, including treatment, scheduled visits, and examinations.
- •? ECOG performance capability status 0~2.
- •? There must be a measurable lesion (RECIST 1.1)
- •? The patient's life expectancy should be at least 3 months from the proposed first administration date.
- •? Patients must have acceptable bone marrow, liver and kidney function test results measured within 28 days prior to administration of the test treatment as specified below:
- •A. Hemoglobin = 9.0 g/L (transfusion allowed)
- •B. Absolute neutrophil count (ANC) = 1.5 x 109/L
- •C. White blood cells (WBC)> 3 x 109/L
- •D. Platelet count = 100 x 109/L (transfusion allowed)
- •E. Total bilirubin = 1.5 x laboratory's upper limit of normal (ULN) (Glibert's disease is not included)
- •F. AST(SGOT)/ALT(SGPT) = 2.5 x Upper normal limit of laboratory. However, except for the presence of liver metastasis (must be = 5x ULN)
- •G. Serum creatinine = 1.5 x ULN of laboratory
- •? Urine or serum pregnancy test negative within 28 days of test treatment, confirmed before treatment on the first day (for women of childbearing potential)
- •? When the disease progresses, tissue biopsy can be performed if possible.
- •? Stored tissue or fresh tissue biopsy must be possible before starting treatment.
排除标准
- •? Patients with poor general condition (patients with ECOG PS of 3 or higher).
- •? Patients with second primary cancer, Exception: Non-melanoma skin cancer that has been properly treated, cured cervical intraepithelial cancer, or other solid tumors cured within 5 years without evidence of disease.
- •? Patients in the acute stage of infection.
- •? Treatment with investigational drugs for the most recent 14 days (or a longer period depending on the prescribed characteristics of the product used) before registration.
- •? Patients who received systemic chemotherapy or radiation therapy (except for palliative purposes) within 3 weeks (or longer period depending on the prescribed characteristics of the formulation used) after the last administration before the trial treatment.
- •? Excluding hair loss, all toxicities in progress caused by previous cancer therapy (> CTCAE Grade 1).
- •? If the QTc measurable by ECG is> 480msec at rest at 2 or more times within 24 hours, or if there is a family history of QT prolonged syndrome.
- •? Patients with the following heart problems: uncontrolled high blood pressure (BP = 150/95mmHg despite medical treatment), left ventricular ejection coefficient <55% measured by echocardiography, an atrium with ventricular rate> 100 bpm on ECG at rest Fibrillation, symptomatic heart failure (grades NYHA II-IV), previous or present cardiomyopathy, severe valvular heart disease, uncontrolled angina (degrees II-IV of the Canadian Cardiovascular Society, despite medical treatment), 6 months prior to initiation of treatment Within acute coronary syndrome.
- •? There is evidence of severe or uncontrolled systemic disease, active infection, active bleeding constitution, or kidney transplant, including in patients known as hepatitis B, C, or human immunodeficiency virus (HIV).
- •? History of allergy or hypersensitivity to Pemetrexed, Erlotinib
- •? Pregnancy or breastfeeding
- •? Patients with genetic problems such as galactose intolerance, Lapp lactose deficiency, or glucose galactose absorption disorder
研究者
相似试验
已完成
1 期
A Phase I/II study of Pemetrexed plus Erlotinib therapy in Previously Treated Non-Small-Cell Lung Cancer.on-small cell lung cancerJPRN-UMIN000002900Osaka Univ.Hospital Respiratory Medicine40
招募中
2 期
A phase II study of Erlotinib plus Pemetrexed for Non Small Cell Lung Cancer with T790M negative previously treated with EGFR-TKIon-small cell lung cancerJPRN-UMIN000008033Toho University Omori Medical Center15
已完成
2 期
A phase II study of Erlotinib plus Pemetrexed for previously treated Non Small Cell Lung Canceron-Small Cell Lung CancerJPRN-UMIN000007397Kochi University, School of Medicine, Department of Hematology and Resporatory Medicine27
已完成
2 期
Erlotinib Versus Pemetrexed as Second-Line Therapy in Treating Patients With Advanced Lung AdenocarcinomaLung CancerNCT01565538Si-Yu Wang123
已完成
不适用
The combination therapy of pemetrexed and continued EGFR-TKIs beyond disease progression to first-line EGFR-TKIs treatments in elderly patients with advanced non-small-cell lung cancer harboring EGFR mutations: a phase 2 trial.non-small-cell lung cancerJPRN-UMIN000010935Second Division, Department of Internal Medicine, Hamamatsu University School of Medicine22