Phase II Study of Valproate and Doxorubicin in Malignant Mesothelioma

Malignant Mesothelioma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00634205
• Other study ID #: ELCWP-01062
• Status: Completed
• Phase: Phase 2
• First received: March 5, 2008
• Last updated: February 11, 2015
• Start date: July 2006
• Est. completion date: June 2010

Study information

• Verified date: February 2015
• Source: European Lung Cancer Working Party
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health ProductsFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: June 2010
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Lung Neoplasms
• Malignant Mesothelioma
• Mesothelioma

Intervention

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

Locations

Country	Name	City	State
Belgium	Department of Pneumology CHR St joseph - Warquignies	Boussu
Belgium	Department of Intensive Care Unit and Thoracic Oncology Institut Jules Bordet	Brussels
Belgium	Department of Pneumology Hôpital Ixelles-Molière	Brussels
Belgium	Department of Pneumology CHU Charleroi	Charleroi
Belgium	Department of Pneumology Hôpital Saint-Joseph	Gilly
Belgium	Hôpital Ambroise Paré	Mons
Belgium	CH Peltzer-La Tourelle	Verviers
France	Department of Pneumology CHRU Lille	Lille

Sponsors (1)

Lead Sponsor	Collaborator
European Lung Cancer Working Party

Countries where clinical trial is conducted

Belgium,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate		Every 3 courses	Yes
Secondary	Survival		Survival will be dated from the day of registration until death or last follow up	No
Secondary	Toxicity		After each course of chemotherapy and at the end of treatment	No

External Links

•   Click here for more information on the protocol
•   Trials registry of the French National Cancer Institute