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

European Lung Cancer Working Party

Status and phase

Completed

Phase 2

Conditions

Small Cell Lung Carcinoma

Treatments

Drug: Adriamycin, cyclophosphamide, vindesine, valproic acid

Study type

Interventional

Funder types

Other

Identifiers

NCT00759824

01081

Details and patient eligibility

About

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.

Enrollment

64 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.