EUCTR2012-001103-21-IT进行中（未招募）不适用
MANTAINANCE METRONOMIC PER OS NAVELBINE IN ADVANCED NSCLC PATIENTS AFTER PREVIOUS PLATINUM BASED CHEMOTHERAPY: A MULTICENTER RANDOMIZED BEST SUPPORTIVE CARE CONTROLLED PHASE II STUDY: MA.NI.LA. TRIAL.
ISTITUTO NAZIONALE PER LA CURA TUMORI0 个研究点开始时间: 2012年6月21日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- 性别
- All
入选标准
- •1. Signed and dated IEC-approved informed consent. 2. Histologically or cytologically confirmed diagnosis of NSCLC. 3. Stage IV (using the 7th edition of AJCC, or wet IIIb / IV using the 6th edition), or recurrent locally advanced disease not amenable to radiation or surgery with curative intent and not amenable to concurrent chemoradiation. 4. Patients with stable disease, according to RECIST 1.1, after four-six cycles of platinum-based chemotherapy as first line therapy. Patients who obtained partial or complete response during first line treatment must be excluded from the trial. 5. Patients who may have received adjuvant treatment (containing also vinorelbine) at least 6 months before study entry. 6. ECOG performance status 0-2. 7. Adequate bone marrow reserve as measured by ANC >/= 1500/mm3, hemoglobin >/= 9 g/dL, platelet count >/= 75,000 mcL, >/= 1 week after last transfusion of blood products and/or last dose of hematopoietic growth factor. 8. Prothrombin time (PT) or INR or aPTT 45 mL/min. 10. AST (SGOT) and ALT (SGPT) < 2.5 x ULN, AST and ALT < 5 x ULN (if documented liver metastases). 11. Serum bilirubin < 2.0 mg/dL (patients with Gilbert's syndrome: serum bilirubin /= 18.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 90
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •1. Patients who have received induction therapy with a platinum based chemotherapy doublet and achieved a Partial Response (PR) or a Complete Respose (CR) or a progressive disease (PD). 2. Patients who have received, or are scheduled to receive, single agent or combination therapy consisting of chemotherapy, targeted, biological, investigational, hormonal as maintenance treatment. 3. Patients who have received previous treatment for metastatic disease with chemotherapy containing oral or i.v. vinorelbine formulation. 4. Last dose of induction chemotherapy < 21 days prior to randomization or > 42 days prior to randomization. 5. Concurrent treatment with other experimental drugs. 6. Radiation therapy within 3 weeks prior to randomization (palliative radiation therapy is allowed, provided that sites of bone marrow production, i.e., iliac crests are not in the radiation field). 7. Major surgery within 4 weeks prior to first study drug administration. 8. Active central nervous system (CNS) metastatic disease. Patients with stable CNS disease following completion of radiation therapy and/or surgery are eligible. 9. Active or chronically recurrent bleeding (e.g., active peptic ulcer disease). 10. Malabsorption syndrome or any other disorder that would affect gastrointestinal absorption. 11. Clinically significant infection. 12. Clinically significant cardiovascular disease or condition including: congestive heart failure (CHF) requiring therapy, need for anti-arrhythmic therapy for a ventricular arrhythmia, severe conduction disturbance, angina pectoris requiring therapy, medically uncontrolled hypertension per the Investigator's discretion, myocardial infarction within 6 months prior to first study drug administration, New York Heart Association Class II, III, or IV cardiovascular disease. 13. Any other severe, acute, or chronic medical or psychiatric condition, laboratory abnormality, or difficulty complying with protocol requirements that may increase the risk associated with study participation or study drug administration or may interfere with the interpretation of study results and, in the judgment of the Investigator. 14. Past or current history of neoplasm other than curatively treated non-melanoma skin cancer or carcinoma in situ of the uterine cervix, unless that prior malignancy was diagnosed and definitely treated at least 3 years previously with no subsequent evidence of recurrence.
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