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
Phase 2
Completed
- Conditions
- Small Cell Lung Carcinoma
- Interventions
- Drug: Adriamycin, cyclophosphamide, vindesine, valproic acid
- Registration Number
- NCT00759824
- Lead Sponsor
- European Lung Cancer Working Party
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 64
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 Adriamycin, cyclophosphamide, vindesine, valproic acid Chemotherapy regimen (adriamycin, cyclophosphamide, vindesine) plus valproic acid
- Primary Outcome Measures
Name Time Method Six-months progression-free survival The period between the day of registration and the date of first progression
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (5)
Department of Intensive Care Unit and Thoracic Oncology Institut Jules Bordet
🇧🇪Brussels, Belgium
Department of Pneumology CHU Charleroi
🇧🇪Charleroi, Belgium
Department of Pneumology Hôpital Saint-Joseph
🇧🇪Gilly, Belgium
Hôpital Ambroise Paré
🇧🇪Mons, Belgium
Department of Pneumology Centre Hospitalier de Mouscron
🇧🇪Mouscron, Belgium