Small Cell Lung Carcinoma
Conditions
Keywords
Small cell lung carcinoma, Valproic acid, Adriamycin, Cyclophosphamide, Vindesine, Second-line chemotherapy
Brief summary
The primary aim of this study is to determine if the addition of valproic acid to a combination of adriamycin, cyclophosphamide and vindesine could increase progression-free survival in patients relapsing after first-line chemotherapy including platinum derivatives, cisplatin or carboplatin, and etoposide.
Interventions
DRUGAdriamycin, cyclophosphamide, vindesine, valproic acid
Adriamycin 45 mg/m² day 1 IV Cyclophosphamide 1 g/m² day 1 IV Vindesine 3 mg/m² day 1 IV Valproic acid 20-30 mg/kg/day from day -7 until the end of treatment, orally
Sponsors
European Lung Cancer Working Party
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Six-months progression-free survival | The period between the day of registration and the date of first progression |
Secondary
| Measure | Time frame |
|---|---|
| Survival | Survival will be dated from the date of registration |
| Response rate | Every three cycles of chemotherapy |
| Toxicity | After each course of chemotherapy and at the end of treatment |
Countries
Belgium
Outcome results
None listed