A phase II study of doxorubicin, cyclophosphamide and vindesine with valproic acid in patients with refractory or relapsing small cell lung cancer after platinum derivatives and etoposide.

Institut Jules Bordet0 个研究点目标入组 43 人开始时间: 2008年7月8日最近更新: 2021年4月5日

适应症

试验速览

暂无简介。

•-Histological or cytological diagnosis of small-cell lung cancer (SCLC)
•-SCLC refractory to prior chemotherapy regimen including platinum derivatives (cisplatin or carboplatin) and etoposide, either primary refractory (immediate progression or recurrence less than 3 months after the end of previous chemotherapy) or secondary refractory (sensitive patients to platinum plus etoposide in first-line, progressing or recurring less than 3 months after reintroduction of the same chemotherapy).
•-At least one evaluable or measurable lesion
•-Availability for participating in the detailed follow-up of the protocol
•-Signed informed consent
•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

•-Patient who were previously treated with anthracyclin or vinca-alcaloid derivatives or cyclophosphamide
•-Performance status < 60 on the Karnofsky scale
•-A history of prior malignant tumour, except non-melanoma skin cancer or in situ carcinoma of the cervix or of the bladder or cured malignant tumour (more than 5-year disease free interval)
•-A history of prior HIV infection
•-Polynuclear cells < 2,000/mm³
•-Platelet cells < 100,000/mm³
•-Abnormal coagulation tests (aPTT, PTT, prothrombin time) and/or decreased fibrinogen
•-Serum bilirubin >1.5 mg/100 ml
•-Transaminases more than twice the normal range
•-Serum creatinine > 1.5 mg/100 ml
•-Recent myocardial infarction (less than 3 months prior to date of diagnosis)
•-Congestive cardiac failure (ejection fraction of the left ventricle < 50%) or uncontrolled cardiac arrhythmia
•-Uncontrolled infectious disease
•-Active epilepsy needing a specific treatment
•-Concomitant treatment with IMAO, carbamazepine, mefloquine, phenobarbital, primidone, phenytoïn, lamotrigine, zidovudine
•-Pregnancy or refusal to use active contraception
•-A known allergy to valproic acid and/or doxorubicin, cyclophosphamide, vindesine
•- Serious medical or psychological factors which may prevent adherence to the treatment schedule.

发起方

Institut Jules Bordet