Status:
COMPLETED
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
Lead Sponsor:
European Lung Cancer Working Party
Conditions:
Small Cell Lung Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 relap...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT00759824
Start Date
September 1 2008
End Date
June 1 2014
Last Update
February 12 2015
Active Locations (5)
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1
Department of Intensive Care Unit and Thoracic Oncology Institut Jules Bordet
Brussels, Belgium, 1000
2
Department of Pneumology CHU Charleroi
Charleroi, Belgium, 6000
3
Department of Pneumology Hôpital Saint-Joseph
Gilly, Belgium, 6060
4
Hôpital Ambroise Paré
Mons, Belgium, 7000