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临床试验/EUCTR2011-002145-35-DE
EUCTR2011-002145-35-DE进行中（未招募）不适用

SELECT-A: TS stratified Chemotherapy and VEGF Inhibition in Non-Squamous Non-Small Cell Lung Cancer - Stage IV

Aktion Bronchialkarzinom (ABC) e.V.0 个研究点目标入组 146 人开始时间: 2012年7月24日最近更新:
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试验速览

阶段
不适用
状态
进行中（未招募）
发起方
入组人数
146
研究概览入排标准研究者记录与标识符相似试验

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. Histological confirmed Non-Small-Cell lung cancer
  • •2. Tumor stage IV (UICC 7th Version)
  • •3. The following histological tumor types are eligible:
  • •- Adenocarcinoma (including adenocarcinomas with bronchioloalveolar differentiation)
  • •- Large Cell carcinoma without neuroendocrine differentiation
  • •- Mixed Cell Carcinoma without small cell fraction and without predominant squamous cell fraction
  • •- undifferentiated non-small-cell-carcinoma
  • •4. No previous chemotherapy for stage IV NSCLC
  • •5. Adjuvant or neoadjuvant chemotherapy for NSCLC must be
  • •completed at least one year prior to study enrolment (from end of chemotherapy)
  • •6. No previous treatment with Pemetrexed or Bevacizumab
  • •7. Patients with prior radiation therapy may be eligible for this study if they meet the following guidelines:
  • •- Previous radiation therapy is allowed to <25% of the bone marrow (Cristy and Eckerman 1987), but should have been limited and must not have included whole pelvis radiation
  • •- Patients must have recovered from the toxic effects of the treatment prior to study enrollment (except for alopecia)
  • •- Prior thoracic radiotherapy must be completed 30 days before study enrollment
  • •- Lesions that have been radiated cannot be included as sites of measurable disease unless clear tumor progression has been
  • •documented in these lesions since the end of radiation therapy
  • •- Palliative extrathoracic radiotherapy to preexisting lesions may continue on study; however, these lesions may not be included as sites of measurable disease.
  • •8. At least 4 weeks since last major surgery
  • •9. Age = 18 and = 70 years
  • •10. ECOG = 1
  • •11. Adequate hematological laboratory parameters:
  • •- Hemoglobin = 9 g/dl
  • •- Neutrophils = 1.500 µl
  • •- WBC = 3.000 µl
  • •- Platelets = 100.000 µl
  • •12. Adequate hepatic laboratory parameters:
  • •- Total Bilirubin = 1,5 x ULN
  • •- Alkaline phosphatase = 3 x ULN
  • •- AST(GOT) < 2,5 ULN in patients without liver metastasis < 5 x ULN in patients with liver metastasis ULN = (upper limit of normal)
  • •- ALT(GPT) < 2,5 ULN in patients without liver metastasis < 5 x ULN in patients with liver metastasis ULN = (upper limit of normal)
  • •13. Adequate renal laboratory parameters:
  • •- Creatinine Clearance > 50 ml/min
  • •- Urine dipstick for proteinuria < 2+
  • •Patientients discovered to have = 2+ proteinuria on dipstick urinalysis at baseline should undergo a 24-hour urine collection and must demonstrate <1 g of protein in 24 hours
  • •14. Normal cardiac function defined by New York Heart Association – NYHA Class I and Class II
  • •15. Electrocardiogram without significant signs of cardiac arrhythmias
  • •16. Provision of informed consent according to local regulatory requirements prior to any protocol specific treatment
  • •18. Measurable lesion according to RECIST 1.1
  • •19. Negative pregnancy test for women of childbearing potential unless they are postmenopausal at baseline.(Postmenopausal women must have been amenorrheic at least for 12 months to be considered of non childbearing potential)
  • •20. Women of child bearing potential and men to be willing to use an acceptable method to avoid pregnancy at least one month before study start. Examples: oral contraceptives (sole application of oral contraceptives is not sufficient), diaphragm pessary, intrauterine device (spiral), condom plus diaphragm pessary plus spermicide
  • •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 110
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for

排除标准

  • •1. Histological confirmed predominant squamous cell carcinoma
  • •2. Presence of activating EGFR mutations in exons 18-21
  • •3. Pregnancy or lactation period
  • •4. Have known central nervous system disease, other than stable, treated brain metastasis. Stable, treated brain metastasis is defined as metastasis having no evidence of progression or
  • •hemorrhage after treatment and no ongoing requirement for dexamethasone, as ascertained by clinical examination and posttreatment brain imaging. Patients should be off corticosteroids for 1 week at the time of the post-treatment brain CT/MRI. Anticonvulsants are allowed. Treatment for brain metastases may
  • •include whole brain radiotherapy, radiosurgery, or a combination as deemed appropriate by the treating physician, and must have been completed > 28 days prior to Day 1 of Cycle 1. Patients with CNS metastases treated by neurosurgical resection or brain biopsy performed within 8 weeks prior to Day 1 of Cycle 1 will be excluded
  • •5. Evidence of tumor invading or abutting major blood vessels
  • •6. Presence of a tracheobronchial fistula
  • •7. History of abdominal fistula or fistulisation of urogenital tract,
  • •gastrointestinal perforation or intra-abdominal abscess, inflammatory bowel disease, or diverticulitis within 6 months prior to study start
  • •8. Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of a CIS of the cervix, nonmelanomatous skin cancer, stable chronic lymphatic leukaemia,
  • •non-muscle invasive bladder cancer or surgically treated or irradiated prostate cancer with no signs of recurrence for one year. Patients with other malignancies curatively treated and free of disease for at least 5 years will be discussed with the Principal Investigator before inclusion
  • •9. Treatment with an investigational new drug, currently or within the last 28 days, and/or participation in another clinical trial, currently or during the last 12 weeks, and/or previous participation in this study.
  • •10. History or presence of a mental disease or condition such as to interfere with the patient's ability to understand the requirements of the study and the intake of study medication according to study protocol.
  • •11. Patients with any clinically significant disease that in the opinion of the investigator is likely to put the patient at risk or to interfere with the evaluation of the patient's safety and of the study outcome. This includes, but is not limited to:
  • •- Immediate need for therapeutic intervention
  • •- Clinically significant cardiac disease or myocardial infarction within the last 6 months
  • •12. Have a history of hypertension, unless hypertension is well controlled upon study entry and the patient is on a stable regimen of antihypertensive therapy. Patients should not have any prior history of hypertensive crisis or hypertensive encephalopathy.
  • •13. Non healing wound, ulcer or bone fracture
  • •14. Fresh thrombosis under full dose therapy with anticoagulants
  • •15. History of thrombotic disorders within the last 6 months prior to entry
  • •16. Current or recent full-dose oral or parenteral anticoagulants, or thrombolytic agents for therapeutic purposes
  • •17. Prophylactic use of anticoagulants is allowed; international normalized ratio should be <1.5 at study enrollment.
  • •18. Current or recent use of ASS – Dosage > 325 mg/day
  • •19. Current or recent use of Plavix/Clopidogrel, at doses >75 mg/d, dipyramidole, ticlopidine, cilostazol
  • •20. Hemorrhagic diathesis, Hemophilia A, Hemophilia B
  • •21. Implantation o

研究者

发起方
Aktion Bronchialkarzinom (ABC) e.V.

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