Phase II Study of Valproate and Doxorubicin in Malignant Mesothelioma - Full Text View

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

MedlinePlus related topics:

Mesothelioma

Drug Information available for:

Doxorubicin Doxorubicin hydrochloride Divalproex sodium Valproate Sodium Valproic acid

U.S. FDA Resources

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

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

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
A: Experimental 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

Contacts


Contact: Nathalie Leclercq, RN	0032/2/5390496	nathalie.leclercq@bordet.be

Contact: Thierry Berghmans, MD	0032/2/5413111

Locations


Belgium
	Department of Intensive Care Unit and Thoracic Oncology Institut Jules Bordet	Recruiting
	Brussels, Belgium, 1000
	Contact: Thierry Berghmans, MD 0032/2/5390496
	Principal Investigator: Thierry Berghmans, MD
	Department of Pneumology CHU Charleroi	Recruiting
	Charleroi, Belgium, 6000
	Contact: Jacques Lecomte, MD
	Principal Investigator: Jacques Lecomte, MD
	Department of Pneumology Hôpital Saint-Joseph	Recruiting
	Gilly, Belgium, 6060
	Contact: Benoît Colinet, MD
	Principal Investigator: Benoît Colinet, MD
	Department of Pneumology CHR St joseph - Warquignies	Recruiting
	Boussu, Belgium, 7360
	Contact: Michel Richez, MD
	Principal Investigator: Michel Richez, MD
	CH Peltzer-La Tourelle	Recruiting
	Verviers, Belgium, 4800
	Contact: Yves Bonduelle, MD
	Principal Investigator: Yves Bonduelle, MD
	Sub-Investigator: Ingrid Louviaux, MD
	Hôpital Ambroise Paré	Recruiting
	Mons, Belgium, 7000
	Contact: Patricia Wackenier, MD
	Principal Investigator: Patricia Wackenier, MD
	Sub-Investigator: Stéphane Holbrechts, MD
	Department of Pneumology Hôpital Ixelles-Molière	Recruiting
	Brussels, Belgium
	Contact: Saida Bensliman, MD
	Principal Investigator: Saida Bensliman, MD

France
	Department of Pneumology CHRU Lille	Recruiting
	Lille, France
	Contact: Arnaud Scherpereel, MD, PhD 0033/320/444998
	Principal Investigator: Arnaud Scherpereel, MD, PhD

Sponsors and Collaborators

European Lung Cancer Working Party

Investigators


Study Chair:	Thierry Berghmans, MD	European Lung Cancer Working Party

More 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

Responsible Party:	European Lung Cancer Working Party ( Dr Thierry Berghmans )
Study ID Numbers:	ELCWP-01062
First Received:	March 5, 2008
Last Updated:	March 5, 2008
ClinicalTrials.gov Identifier:	NCT00634205
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

Study placed in the following topic categories:

Mesothelioma

Valproic Acid

Adenoma

Doxorubicin

Recurrence

Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Neurotransmitter Agents

Neoplasms by Histologic Type

Tranquilizing Agents

Molecular Mechanisms of Pharmacological Action

Antineoplastic Agents

Neoplasms, Mesothelial

Physiological Effects of Drugs

Psychotropic Drugs

Central Nervous System Depressants

Enzyme Inhibitors

Antibiotics, Antineoplastic

Antimanic Agents

Pharmacologic Actions

Neoplasms

Therapeutic Uses

GABA Agents

Central Nervous System Agents

Anticonvulsants

ClinicalTrials.gov processed this record on November 20, 2008

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