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Phase II Study of Valproate and Doxorubicin in Malignant Mesothelioma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00634205
Recruitment Status : Completed
First Posted : March 12, 2008
Last Update Posted : February 12, 2015
Information provided by (Responsible Party):
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 .

Condition or disease Intervention/treatment Phase
Malignant Mesothelioma Drug: Valproate plus doxorubicin Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study Assessing the Activity of Valproate Acid Plus Doxorubicin in Refractory or Recurrent Malignant Mesothelioma
Study Start Date : July 2006
Actual Primary Completion Date : March 2009
Actual Study Completion Date : June 2010

Arm Intervention/treatment
Experimental: A
Continuous oral administration of valproate plus every 3 weeks, intravenous administration of doxorubicin
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

Primary Outcome Measures :
  1. Response rate [ Time Frame: Every 3 courses ]

Secondary Outcome Measures :
  1. Survival [ Time Frame: Survival will be dated from the day of registration until death or last follow up ]
  2. Toxicity [ Time Frame: After each course of chemotherapy and at the end of treatment ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00634205

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Department of Pneumology CHR St joseph - Warquignies
Boussu, Belgium, 7360
Department of Intensive Care Unit and Thoracic Oncology Institut Jules Bordet
Brussels, Belgium, 1000
Department of Pneumology Hôpital Ixelles-Molière
Brussels, Belgium
Department of Pneumology CHU Charleroi
Charleroi, Belgium, 6000
Department of Pneumology Hôpital Saint-Joseph
Gilly, Belgium, 6060
Hôpital Ambroise Paré
Mons, Belgium, 7000
CH Peltzer-La Tourelle
Verviers, Belgium, 4800
Department of Pneumology CHRU Lille
Lille, France
Sponsors and Collaborators
European Lung Cancer Working Party
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Study Chair: Thierry Berghmans, MD European Lung Cancer Working Party
Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: European Lung Cancer Working Party Identifier: NCT00634205    
Other Study ID Numbers: ELCWP-01062
First Posted: March 12, 2008    Key Record Dates
Last Update Posted: February 12, 2015
Last Verified: February 2015
Keywords provided by European Lung Cancer Working Party:
Phase II
Additional relevant MeSH terms:
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Lung Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Mesothelial
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Valproic Acid
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
GABA Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs