A randomised phase II study of pemetrexed compared to pemetrexed-carboplatin in pretreated patients with advanced NSCLC

VALT/Vrije Universiteit Medical CentreAmsterdam0 个研究点目标入组 230 人开始时间: 待定最近更新: 2024年2月28日

适应症

试验速览

•1.Histologically or cytologically confirmed NSCLC locally advanced and metastatic disease stage IIIB and IV, with evidence of disease progression after cytotoxic treatment which should have included a platinum agent.
•2.At least 3 months from prior chemotherapy with complete recovery from first line chemotherapy side effects to < Grade 2
•3.At least one unidimensionally measurable leasion meeting RECIST criteria.
•4.ECOG PS 0-2
•5.Age > 18 years
•6.Adequate organ function, including:
•a.Adequate bone marrow reserve: ANC > 1.5 x 109/L, platelets > 100 x 109/L.
•b.Hepatic: bilirubin <1.5 x ULN, AP, ALT, AST < 3.0 x ULN AP, ALT, and AST <5 xULN is acceptable if the liver has tumor involvement
•c.Renal: calculated creatinine clearance > 45 ml/min based on the Cockroft and Gault formula.
•7.Signed informed consent
•8.Male and female patients with reproductive potential must use an approved contraceptive method, if appropriate. Female patients with childbearing potential must have a negative serum pregnancy test within 7 days prior to study enrollment.
•9.Estimated life expectancy >12 weeks
•10. Patient compliance and geographical proximity that allow adequate follow up.

•1.Pregnant or lactating women
•2.Patients who are poor medical risks because of non-malignant disease as well as those with active uncontrolled infection.
•3.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.
•4.Concomitant treatment with any other experimental drug under investigation.
•5.Inability to interrupt aspirin or other nonsteroidal anti-inflammatory agents for a 5-day period (8 day period for long-acting agents such as piroxicam).
•6.Inability or unwillingness to take folic acid, vitamin B-12 supplementation or dexamethasone.

发起方

VALT/Vrije Universiteit Medical CentreAmsterdam