Phase II Study of Valproate and Doxorubicin in Malignant Mesothelioma

The recruitment status of this study is unknown because the information has not been verified recently.

Verified April 2009 by European Lung Cancer Working Party. Recruitment status was Active, not recruiting

First Received on March 5, 2008. Last Updated on April 3, 2009 History of Changes

Sponsor:	European Lung Cancer Working Party
Information provided by:	European Lung Cancer Working Party
ClinicalTrials.gov Identifier:	NCT00634205

Purpose

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	Intervention	Phase
Malignant Mesothelioma	Drug: Valproate plus doxorubicin	Phase II

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Mesothelioma

Drug Information available for: Doxorubicin Doxorubicin hydrochloride Divalproex sodium Valproic acid Valproate Sodium

U.S. FDA Resources

Further study details as provided by European Lung Cancer Working Party:

Primary Outcome Measures:

Response rate [ Time Frame: Every 3 courses ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Survival [ Time Frame: Survival will be dated from the day of registration until death or last follow up ] [ Designated as safety issue: No ]
Toxicity [ Time Frame: After each course of chemotherapy and at the end of treatment ] [ Designated as safety issue: No ]

Estimated Enrollment:	41
Study Start Date:	July 2006
Estimated Study Completion Date:	June 2010
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00634205

Locations

Belgium
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
France
Department of Pneumology CHRU Lille
Lille, France

Sponsors and Collaborators

European Lung Cancer Working Party

Investigators

Study Chair:

Thierry Berghmans, MD

European Lung Cancer Working Party

More Information

Additional Information:

Click here for more information on the protocol This link exits the ClinicalTrials.gov site

Trials registry of the French National Cancer Institute This link exits the ClinicalTrials.gov site

No publications provided by European Lung Cancer Working Party

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. Epub 2010 Jun 7.

Responsible Party:	Dr Thierry Berghmans, European Lung Cancer Working Party
ClinicalTrials.gov Identifier:	NCT00634205 History of Changes
Other Study ID Numbers:	ELCWP-01062
Study First Received:	March 5, 2008
Last Updated:	April 3, 2009
Health Authority:	Belgium: Federal Agency for Medicinal Products and Health Products; France: Afssaps - French Health Products Safety Agency

Keywords provided by European Lung Cancer Working Party:

Mesothelioma
Valproate
Doxorubicin
Chemotherapy
Phase II

Additional relevant MeSH terms:

Mesothelioma
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Mesothelial
Valproic Acid
Doxorubicin
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

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
Antibiotics, Antineoplastic
Antineoplastic Agents

ClinicalTrials.gov processed this record on February 09, 2012