Clinical trial NCT00634205: Phase II Study of Valproate and Doxorubicin in Malignant Mesothelioma
Official title: A Phase II Study Assessing the Activity of Valproate Acid Plus Doxorubicin in Refractory or Recurrent Malignant Mesothelioma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Malignant Mesothelioma
Keywords: Mesothelioma
Valproate
Doxorubicin
Chemotherapy
Phase II
Lead sponsor: European Lung Cancer Working Party
Sponsor class: OTHER
First posted: 2008-03-12
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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 .


Eligibility 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

Primary outcomes:
measure: Response rate
timeFrame: Every 3 courses
Secondary outcomes:
measure: Survival
timeFrame: Survival will be dated from the day of registration until death or last follow up
measure: Toxicity
timeFrame: After each course of chemotherapy and at the end of treatment
Other outcomes:
Locations:
city: Boussu
country: Belgium
facility: Department of Pneumology CHR St joseph - Warquignies
city: Brussels
country: Belgium
facility: Department of Intensive Care Unit and Thoracic Oncology Institut Jules Bordet
city: Brussels
country: Belgium
facility: Department of Pneumology Hôpital Ixelles-Molière
city: Charleroi
country: Belgium
facility: Department of Pneumology CHU Charleroi
city: Gilly
country: Belgium
facility: Department of Pneumology Hôpital Saint-Joseph
city: Mons
country: Belgium
facility: Hôpital Ambroise Paré
city: Verviers
country: Belgium
facility: CH Peltzer-La Tourelle
city: Lille
country: France
facility: Department of Pneumology CHRU Lille
Study officials:
affiliation: European Lung Cancer Working Party
name: Thierry Berghmans, MD
role: STUDY_CHAIR
References:
citation: Scherpereel A, Berghmans T, Lafitte JJ, Colinet B, Richez M, Bonduelle Y, Meert AP, Dhalluin X, Leclercq N, Paesmans M, Willems L, Sculier JP; European Lung Cancer Working Party (ELCWP). Valproate-doxorubicin: promising therapy for progressing mesothelioma. A phase II study. Eur Respir J. 2011 Jan;37(1):129-35. doi: 10.1183/09031936.00037310. Epub 2010 Jun 7.