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
- Conditions
- SCLC (Non-small Cell Lung Cancer) stage IIIB/IVMedDRA version: 13.1Level: PTClassification code 10029522Term: Non-small cell lung cancer stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 13.1Level: PTClassification code 10029521Term: Non-small cell lung cancer stage IIIBSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
- Registration Number
- EUCTR2007-001262-32-DE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
– 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
– 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)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Comparison of overall response rates (ORR) in the 2 treatment arms;Secondary Objective: Comparison of the 2 treatment arms with regard to<br>- time to progression (TTP)<br>- overall survival (OS)<br>- toxicity profile;Primary end point(s): Overall response rates according to RECIST in all randomized patients having received at least one dose of study medication unless the patient was lost to follow-up immediately after the start of treatment
- Secondary Outcome Measures
Name Time Method