Phase II Study of Valproate and Doxorubicin in Malignant Mesothelioma

Condition(s) targeted: Malignant Mesothelioma

Intervention: Valproate plus doxorubicin (Drug)

Phase: Phase 2

Status: Recruiting

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

Overall contact:
Nathalie Leclercq, RN, Phone: 0032/2/5390496, Email: nathalie.leclercq@bordet.be

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 .

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

Study design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Efficacy Study

Primary outcome: Response rate

Secondary outcome:

Survival

Toxicity

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

Criteria:

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

schedule

Nathalie Leclercq, RN, Phone: 0032/2/5390496, Email: nathalie.leclercq@bordet.be

Department of Intensive Care Unit and Thoracic Oncology Institut Jules Bordet, Brussels 1000, Belgium; Recruiting
Thierry Berghmans, MD, Phone: 0032/2/5390496
Thierry Berghmans, MD, Principal Investigator

Department of Pneumology CHU Charleroi, Charleroi 6000, Belgium; Recruiting
Jacques Lecomte, MD
Jacques Lecomte, MD, Principal Investigator

Department of Pneumology Hôpital Saint-Joseph, Gilly 6060, Belgium; Recruiting
Benoît Colinet, MD
Benoît Colinet, MD, Principal Investigator

Department of Pneumology CHR St joseph - Warquignies, Boussu 7360, Belgium; Recruiting
Michel Richez, MD
Michel Richez, MD, Principal Investigator

CH Peltzer-La Tourelle, Verviers 4800, Belgium; Recruiting
Yves Bonduelle, MD
Yves Bonduelle, MD, Principal Investigator
Ingrid Louviaux, MD, Sub-Investigator

Hôpital Ambroise Paré, Mons 7000, Belgium; Recruiting
Patricia Wackenier, MD
Patricia Wackenier, MD, Principal Investigator
Stéphane Holbrechts, MD, Sub-Investigator

Department of Pneumology Hôpital Ixelles-Molière, Brussels, Belgium; Recruiting
Saida Bensliman, MD
Saida Bensliman, MD, Principal Investigator

Department of Pneumology CHRU Lille, Lille, France; Recruiting
Arnaud Scherpereel, MD, PhD, Phone: 0033/320/444998
Arnaud Scherpereel, MD, PhD, Principal Investigator

Click here for more information on the protocol

Trials registry of the French National Cancer Institute

Starting date: July 2006
Ending date: June 2010
Last updated: January 27, 2009