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

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 .

Study Type: Interventional

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

Study Primary Completion Date: December 2009

Intervention(s) in this Clinical Trial

• Drug: Valproate plus doxorubicin
  • Valproate 20-30 mg/kg orally (in order to obtain serum concentration between 50-100 mcg/ml) Doxorubicin 60 mg/m² intravenously every 3 weeks

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: A
  • Continuous oral administration of valproate plus every 3 weeks, intravenous administration of doxorubicin

Primary Measures

• Response rate
  • Time Frame: Every 3 courses
    Safety Issue?: Yes

Secondary Measures

• Survival
  • Time Frame: Survival will be dated from the day of registration until death or last follow up
    Safety Issue?: No
• Toxicity
  • Time Frame: After each course of chemotherapy and at the end of treatment
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: European Lung Cancer Working Party

Overall Clinical Trial Officials and Contacts

Thierry Berghmans, MD Study Chair European Lung Cancer Working Party  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00634205

Study ID Number: ELCWP-01062

ClinicalTrials.gov Identifier: NCT00634205

Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

Click here for more information on the protocol

Trials registry of the French National Cancer Institute