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Phase II Study of Valproate and Doxorubicin in Malignant Mesothelioma

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: Malignant Mesothelioma

Intervention: Valproate plus doxorubicin (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 purpose of this study is to determine the response rate to the combination of doxorubicin and valproate acid in patients with MM failing after at least one previous chemotherapy regimen including platinum derivatives .

Clinical Details

Official title: A Phase II Study Assessing the Activity of Valproate Acid Plus Doxorubicin in Refractory or Recurrent Malignant Mesothelioma

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

Primary outcome: Response rate

Secondary outcome:




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


Inclusion Criteria:

- Histological diagnosis of malignant mesothelioma

- Unresectable or inoperable malignant mesothelioma failing after at least one prior

chemotherapy regimen including platinum derivatives (cisplatin or carboplatin)

- At least one evaluable or measurable CT-lesion

- Availability for participating in the detailed follow-up of the protocol

- Signed informed consent

Exclusion Criteria:

- Patients who are candidates for surgery with curative intent

- Patient who were previously treated with anthracyclin derivatives

- 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 and 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 (ejectional 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 valproate acid and/or doxorubicin

- Serious medical or psychological factors which may prevent adherence to the treatment


Locations and Contacts

Department of Pneumology CHR St joseph - Warquignies, Boussu 7360, Belgium

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

Department of Pneumology Hôpital Ixelles-Molière, Brussels, Belgium

Department of Pneumology CHU Charleroi, Charleroi 6000, Belgium

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

Hôpital Ambroise Paré, Mons 7000, Belgium

CH Peltzer-La Tourelle, Verviers 4800, Belgium

Department of Pneumology CHRU Lille, Lille, France

Additional Information

Click here for more information on the protocol

Trials registry of the French National Cancer Institute

Starting date: July 2006
Last updated: February 11, 2015

Page last updated: August 20, 2015

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