EUCTR2006-004009-24-IT进行中（未招募）不适用
Randomized phase II study of pemetrexed versus pemetrexed and carboplatin as second line chemotherapy in advanced non-small-cell lung cancer (NSCLC). - ND
GRUPPO ONCOLOGICO ITALIANO DI RICERCA0 个研究点开始时间: 2007年8月10日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- •The patient must give written (personally signed and dated) informed consent before completing any study related procedure.
- •Males or females >=18 years.
- •Histologically or cytologically confirmed non-small-cell lung cancer (NSCLC).
- •Unresectable stage IIIB, stage IV and unresectable local relapse or metastatic disease, with evidence of disease progression after first line chemotherapy which should have included a platinum agent.
- •ECOG performance status <=2.
- •Life expectancy >= 12 weeks.
- •Adequate hematological, hepatic and renal functions.
- •Prior treatment with only 1 chemotherapy regimen for the treatment of advanced disease which should have included a platinum agent (prior treatment with gefitinib/erlotinib as maintenance after 1st line chemotherapy is allowed and not considered as a chemotherapy regimen).
- •At least 4 weeks from prior chemotherapy with complete recovery from first line chemotherapy side effects to < Grade 2.
- •Prior radiotherapy allowed, only in case of presence of at least one measurable lesion outside an irradiated area. Radiotherapy must have been completed at least 2 weeks before registration.
- •At baseline, presence of at least one measurable target lesion according to RECIST criteria. All radiology studies must be performed within 28 days prior to randomization.
- •Absence of any psychological, familial, sociological or geographical conditions potentially hampering compliance with the study protocol and follow-up schedule.
- •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
- •Prior treatment with pemetrexed.
- •Patients who are:pregnant or lactating;at risk of pregnancy during the study. This must be checked by pregnancy test at study entry. The patient must be receiving a medically accepted contraceptive regimen.
- •Patients with any underlying medical condition that might be aggravated by treatment or which cannot be controlled.
- •Documented brain metastases unless the patient has completed local therapy for central nervous system metastases and has been off corticosteroids for at least two weeks before enrollment.
- •History of another malignancy within the past five years except basal cell carcinoma of the skin or carcinoma in situ of the cervix.
- •Treatment with any investigational drug within the 30 days prior to registration.
- •Concomitant treatment with any other anticancer drug.
- •Known hypersensitivity to the study drugs or to drugs with similar chemical structures.
- •Inability to interrupt aspirin or other non-steroidal anti-inflammatory agents 2 days before, the day of, and 2 days after the dose of pemetrexed single agent or pemetrexed plus carboplatin. If a patient is taking an NSAID (COX-2 inhibitors included) or salicylate with a long half-life (for example, naproxen, piroxicam, diflunisal, nabumetone, rofecoxib or celecoxib) it should not be taken 5 days before the dose of pemetrexed (8-day period for long-acting agents such as piroxicam), the day of, and 2 days after the dose of pemetrexed single agent or pemetrexed plus carboplatin.
研究者
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