EUCTR2007-001262-32-DE进行中（未招募）不适用
Randomized, double-blind phase II study to compare nitroglycerin plus oral vinorelbine plus cisplatin with oral vinorelbine plus cisplatin alone in patients with stage IIIB/IV non-small cell lung cancer (NSCLC) - Vinorelbine + Cisplatin +/- Nitroglycerin in NSCLC
GMIHO Gesellschaft für Medizinische Innovation - Hämatologie und Onkologie mbH0 个研究点开始时间: 2007年4月5日最近更新:
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试验速览
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
- •– Age >= 18 years
- •– Histologically or cytologically (fine needle aspiration) proven NSCLC
- •– First line treatment of NSCLC (no prior chemotherapy or radiotherapy for the treatment of NSCLC) is indicated
- •– NSCLC stage IIIB or stage IV or recurrence after local therapy
- •– At least one measurable lesion (RECIST) of NSCLC
- •– Karnofsky Performance Status >= 70%
- •– Life expectancy >= 12 weeks
- •– Adequate bone marrow, hepatic and renal function:
- •Neutrophils >= 2.0 x 109/l
- •Platelets >= 100 x 109/l
- •Haemoglobin >= 12 g/dl
- •Total bilirubin <= 1.5 x UNL
- •Transaminases <= 2.5 x UNL
- •Alkaline phosphatase <= 2.5 x UNL
- •Creatinine <= 1.5 x UNL (in case of borderline values, creatinine clearance should be determined and should be >= 65 ml/min)
- •– Written informed consent (including consent to data reporting)
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •– Symptomatic neuropathy (sensory) > grade 1 according to CTCAE
- •– CNS metastases
- •– Concomitant / uncontrolled medical disorder (ischaemic heart disease, cardiac failure or myocardial infarction within the previous 3 months; uncontrolled hypertension or arrhythmia; hypotension; active infection requiring intravenous antibiotics within 2 weeks prior to enrollment; uncontrolled hypercalcaemia)
- •– Superior vena cava syndrome
- •– History of other malignancy except carcinoma in situ of the cervix or appropriately treated skin basal cell cancer. Patients with a history of cancer and at least 5 years of uneventful follow-up without treatment and no signs of recurrence may be eligible.
- •– Concomitant or previous treatment of NSCLC with other anticancer drugs or radiotherapy
- •– Previous treatment with vinorelbine
- •– Concomitant treatment with vasodilating drugs (e.g., calcium channel blockers or nitroglycerin [other than study medication])
- •– Known hypersensitivity or contra-indications to study medication (vinorelbine, cisplatin or nitroglycerin) or drugs with similar chemical structures as the study medications
- •– Concomitant treatment with corticosteroids except chronic treatment lasting more than 1 month at low doses (<= 20 mg/day of methylprednisolone or equivalent)
- •– Significant malabsorption syndrome or disease affecting the gastrointestinal tract function and the absorption of oral drugs
- •– Pregnant or breast-feeding women
- •– Male or female patients with reproductive potential must use an approved contraceptive method during and for 6 months after the end of treatment with study medication
- •– Participation to another clinical trial with any investigational drug study (whatever the use, curative, prophylactic or diagnostic intent) within 30 days prior to study screening
- •– Incapability to give valid informed consent (including patients who are dependent on the sponsor or the investigator)
研究者
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