EUCTR2005-002911-26-DE进行中（未招募）不适用
A Randomized Phase 2 Study of Pemetrexed in Combination with Cisplatin or Carboplatin as Adjuvant Chemotherapy in Patients with Completely Resected Stage Ib or II Non-Small Cell Lung Cancer - Not available
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 112
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] Patients with histologically proven and completely resected (R0) stage Ib, IIa or IIb NSCLC.
- •[2] Complete NSCLC tumor resection (R0) by pneumonectomy or lobectomy (sublobar and wedge resection excluded) with resection of any involved N1 lymph nodes, within 3-6 weeks prior to study enrollment.
- •[3] Patients must have been surgically proven to be N2 negative.
- •[4] Performance status of 0 or 1 on the ECOG performance status scale.
- •[5] No previous antitumor- (chemo-, hormonal-, immuno-) therapy.
- •[6] No previous antitumor-radiation therapy.
- •[7] Patients are compliant and live within geographic proximity that allows adequate follow-up.
- •[8] Adequate organ function including the following:
- •Adequate bone marrow reserve: absolute neutrophil (segmented and bands) count (ANC) >=1.5 x 109/L, platelets >=100 x 109/L, and hemoglobin >=9 g/dL.
- •Hepatic: bilirubin <=1.5 times the upper limit of normal, alkaline phosphatase (AP), aspartate transaminase (AST) and alanine transaminase (ALT) <=3.0 x ULN.
- •Renal: calculated creatinine clearance (CrCl) >= 45 mL/min based on the standard Cockroft and Gault formula.
- •[9] Signed informed consent document.
- •[10] At least 18 years of age.
- •[11] For women: Patients are compliant with a medically approved contraceptive regimen during and for 3 months after the treatment period; must have a negative serum or urine pregnancy test and must not be lactating.
- •For men: Patients are compliant with a contraceptive regimen during and for 3 months after the treatment period.
- •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
- •[12] Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
- •[13] Patient has previously completed or withdrawn from this study or any other study investigating pemetrexed.
- •[14] A serious concomitant systemic disorder (e.g., active infection including HIV) that, in the opinion of the investigator, would compromise the patient’s ability to complete the study.
- •[15] Any concomitant systemic disorder that prohibits or interferes with the administration of one of the combination drugs (cisplatin and/or carboplatin).
- •[16] Post-operative complications or other surgery related conditions that could interfere with a study participation.
- •[17] Unable or unwilling to take folic acid, vitamin B12 supplementation or dexamethasone (or equivalent corticosteroid); or any other inability to comply with protocol or study related procedures.
- •[18] A prior malignancy other than NSCLC, except carcinoma in situ of the cervix or non-melanoma skin cancer, unless that prior malignancy was diagnosed and definitively treated at least 5 years previously with no subsequent evidence of recurrence.
- •[19] A significant cardiovascular disease in terms of an abnormal electrocardiogram (ECG) coupled with clinical signs of recent or recurrent cardiac disease (including myocardial infarction within the last 6 months, angina or uncontrolled hypertension).
- •[20] Patient is unable to interrupt aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs) for a 5-day period starting 2 days before administration of pemetrexed (8-day period before long-acting agents such as piroxicam).
- •[21] Clinically significant effusions (pleural or peritoneal) that cannot be drained.
- •[22] Pregnancy or breast-feeding.
- •[23] Concurrent administration of any other antitumor therapy.
研究者
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