Phase II Study of Valproate and Doxorubicin in Malignant Mesothelioma

Phase 2

Completed

• Conditions: Malignant Mesothelioma
• Interventions: Drug: Valproate plus doxorubicin

• Registration Number: NCT00634205
• Lead Sponsor: European Lung Cancer Working Party

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 .

Detailed Description

Not available

Study Timeline

• Study Start: 2006-07
• Study First Submitted: 2008-03-05
• Study First Submitted QC: 2008-03-05
• Study First Posted: 2008-03-12
• Primary Completion: 2009-03
• Study Completion: 2010-06
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-11
• Last Update Posted: 2015-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A	Valproate plus doxorubicin	Continuous oral administration of valproate plus every 3 weeks, intravenous administration of doxorubicin

Primary Outcome Measures

Name	Time	Method
Response rate	Every 3 courses

Secondary Outcome Measures

Name	Time	Method
Survival	Survival will be dated from the day of registration until death or last follow up
Toxicity	After each course of chemotherapy and at the end of treatment

Trial Locations

Locations (8)

Department of Pneumology Hôpital Ixelles-Molière; 🇧🇪 Brussels, Belgium

Department of Pneumology Hôpital Saint-Joseph; 🇧🇪 Gilly, Belgium

Department of Intensive Care Unit and Thoracic Oncology Institut Jules Bordet; 🇧🇪 Brussels, Belgium

Department of Pneumology CHR St joseph - Warquignies; 🇧🇪 Boussu, Belgium

Hôpital Ambroise Paré; 🇧🇪 Mons, Belgium

CH Peltzer-La Tourelle; 🇧🇪 Verviers, Belgium

Department of Pneumology CHRU Lille; 🇫🇷 Lille, France

Department of Pneumology CHU Charleroi; 🇧🇪 Charleroi, Belgium