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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00759824
Other study ID # 01081
Secondary ID
Status Completed
Phase Phase 2
First received September 24, 2008
Last updated February 11, 2015
Start date September 2008
Est. completion date June 2014

Study information

Verified date February 2015
Source European Lung Cancer Working Party
Contact n/a
Is FDA regulated No
Health authority Belgium: Federal Agency for Medicinal Products and Health Products
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 64
Est. completion date June 2014
Est. primary completion date December 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Adriamycin, cyclophosphamide, vindesine, valproic acid
Adriamycin 45 mg/m² day 1 IV Cyclophosphamide 1 g/m² day 1 IV Vindesine 3 mg/m² day 1 IV Valproic acid 20-30 mg/kg/day from day -7 until the end of treatment, orally

Locations

Country Name City State
Belgium 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

Sponsors (1)

Lead Sponsor Collaborator
European Lung Cancer Working Party

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary Six-months progression-free survival The period between the day of registration and the date of first progression Yes
Secondary Survival Survival will be dated from the date of registration No
Secondary Response rate Every three cycles of chemotherapy No
Secondary Toxicity After each course of chemotherapy and at the end of treatment No
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