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

• Status: Completed
• Trial end date: 2014-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: European Lung Cancer Working Party
• Treatments: Cyclophosphamide; Doxorubicin; Etoposide; Liposomal doxorubicin; Valproic Acid; Vindesine

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.

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.