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

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.