EUCTR2009-014677-41-DE进行中（未招募）不适用
CHAMP – An open-label, randomised, multicentre, phase II clinical study of panitumumab plus pemetrexed and cisplatin (PemCisP) versus PemCis in the first-line treatment of patients with stage IIIB or IV primary nonsquamous non-small cell lung cancer, with particular regard to the KRAS status - CHAMP
GMIHO Gesellschaft für Medizinische Innovation - Hämatologie und Onkologie mbH0 个研究点开始时间: 2009年11月2日最近更新:
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研究概览
简要总结
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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
- •- Histologically confirmed diagnosis of inoperable stage IIIB or IV primary pulmonary nonsquamous NSCLC (according to UICC staging valid until 2008)
- •- Sufficient representative sample material for KRAS analysis
- •- Wild-type KRAS
- •- Informed consent of the patient
- •- Aged at least 18 years
- •- WHO Performance Status 0-2
- •- At least one unidimensional, measurable tumour parameter according to RECIST
- •- Life expectancy of al least 12 weeks
- •- Adequate haematological, hepatic, renal and metabolic function parameters:
- •Leukocytes > 3000/mm³, ANC = 1500/mm3, platelets = 100,000/mm3,
- •Creatinine clearance = 50 ml/min and serum creatinine = 1.5 x upper limit of normal
- •Bilirubin = 1.5 x upper limit of normal, GOT-GPT = 2.5 x upper limit of normal in absence of liver metastases, or = 5 x upper limit of normal in presence of liver metastases, AP = 5 x upper limit of normal
- •Magnesium = lower limit of normal; calcium = lower limit of normal
- •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 67
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 67
排除标准
- •- Prior chemotherapy
- •- Clinically manifest, uncontrolled brain metastases
- •- Prior radiotherapy of the parameters to be measured
- •- Peripheral neuropathy NCI grade > 1
- •- Subject pregnant or breast feeding, or planning to become pregnant within 6 months after the end of treatment.
- •- Subject (male or female) is not willing to use highly effective methods of contraception (per institutional standard) during treatment and for 6 months (male or female) after the end of treatment (adequate: oral contraceptives, intrauterine device or barrier method in conjunction with spermicidal jelly).
- •- Serious concurrent diseases
- •- Major surgery within the last 4 weeks before recruitment
- •- On-treatment participation in a clinical study in the period 30 days prior to inclusion
- •- Clinically significant cardiovascular disease in (incl. myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) = 1 year before enrolment.
- •- Ongoing or active infection, including active tuberculosis or known infection with human immunodeficiency virus
- •- Superior vena cava syndrome contraindicating hydration
- •- History of interstitial lung disease, e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan.
- •- Patient with mild to moderate renal insufficiency who are unable to interrupt salicylates (like aspirin) or other nonsteroidal anti-inflammatory drugs (NSAIDS) for a 5-day period starting 2 days before administration of pemetrexed (8-day period for long-acting agents such as piroxicam). Exception: Low dose aspirin (acetyl salicylic acid) intake up to 150 mg per day is permitted without interruption.
- •- Presence of clinically significant third-space fluid collections, for example, ascites or pleural effusions that cannot be controlled by drainage or other procedures
- •- Inability or unwillingness to take folic acid, vitamin B12 supplementation or dexamethasone (or equivalent corticosteroid); or any other inability to comply with protocol or study related procedures
- •- Prior or concurrent malignancy (= 5 years prior to enrolment in study) except non-melanoma skin cancer or cervical carcinoma FIGO stage 0-1 if the patient is continuously disease-free
- •- Known allergic reactions on study medication
研究者
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