Phase II Study of Valproate and Doxorubicin in Malignant Mesothelioma

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

European Lung Cancer Working Party

ClinicalTrials.gov Identifier:

NCT00634205

First received: March 5, 2008

Last updated: January 29, 2013

Last verified: January 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

March 5, 2008

Last Updated Date

January 29, 2013

Start Date ^ICMJE

July 2006

Primary Completion Date

March 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00634205 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Phase II Study of Valproate and Doxorubicin in Malignant Mesothelioma

Official Title ^ICMJE

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

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Malignant Mesothelioma

Intervention ^ICMJE

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

Study Arm (s)

Experimental: A

Continuous oral administration of valproate plus every 3 weeks, intravenous administration of doxorubicin

Intervention: Drug: Valproate plus doxorubicin

Publications *

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.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

June 2010

Primary Completion Date

March 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Belgium, France

Administrative Information

NCT Number ^ICMJE

NCT00634205

Other Study ID Numbers ^ICMJE

ELCWP-01062

Has Data Monitoring Committee

Yes

Responsible Party

European Lung Cancer Working Party

Study Sponsor ^ICMJE

European Lung Cancer Working Party

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:

Thierry Berghmans, MD

European Lung Cancer Working Party

Information Provided By

European Lung Cancer Working Party

Verification Date

January 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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