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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

Information source: European Lung Cancer Working Party
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Small Cell Lung Carcinoma

Intervention: Adriamycin, cyclophosphamide, vindesine, valproic acid (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: European Lung Cancer Working Party

Official(s) and/or principal investigator(s):
Thierry Berghmans, MD, Study Chair, Affiliation: European Lung Cancer Working Party


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.

Clinical Details

Official title: 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

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

Primary outcome: Six-months progression-free survival

Secondary outcome:


Response rate



Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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


Locations and Contacts

Department of Intensive Care Unit and Thoracic Oncology Institut Jules Bordet, Brussels 1000, Belgium

Department of Pneumology CHU Charleroi, Charleroi 6000, Belgium

Department of Pneumology Hôpital Saint-Joseph, Gilly 6060, Belgium

Hôpital Ambroise Paré, Mons 7000, Belgium

Department of Pneumology Centre Hospitalier de Mouscron, Mouscron 7700, Belgium

Additional Information

(Click here for more information on the protocol)

Starting date: September 2008
Last updated: February 11, 2015

Page last updated: August 20, 2015

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