This is a prospective phase II study investigating well-known chemotherapeutic (doxorubicin, cyclophosphamide, vindesine) and antiepileptic (valproate) agents, in combination, for the treatment of refractory or recurrent small cell lung carcinoma after platinum derivatives and etoposide, for which no standard treatment is available in this indication.
Conditions
Sponsors
Institut Jules Bordet
Eligibility
Sex/Gender
All
Inclusion criteria
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 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
Exclusion criteria
Exclusion criteria: - Patient who were previously treated with anthracyclin or vinca-alcaloid derivatives or cyclophosphamide - Performance status 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 |
|---|---|
| Main Objective: To determine 6 months progression-free survival of the combination of doxorubicin, cyclophosphamide and vindesine (VdsAC) plus valproic acid in patients with refractory SCLC after treatment with platinum derivatives, cisplatin or carboplatin, and etoposide.;Secondary Objective: - to determine overall survival of the combination of VdsAC plus valproic acid - to determine response rate of the combination of VdsAC plus valproic acid - to assess the toxicity of the combination of VdsAC plus valproic acid - to assess HDAC activity in blood peripheral lymphocytes in patients treated with VdsAC plus valproic acid - to assess new potential blood and tissue markers of lung cancer pathogenesis or prognosis (endocan, VEGF, VEGF-R2, CCL18, ADAMs, …) in patients treated with VdsAC plus valproic acid;Primary end point(s): To determine 6 months progression-free survival of the combination of doxorubicin, cyclophosphamide and vindesine (VdsAC) plus valproic acid in patients with refractory SCLC after treatment with platinum derivatives, cisplatin or carboplatin, and etoposide | — |
Countries
Belgium
Outcome results
None listed