Phase II Study of Valproate and Doxorubicin in Malignant Mesothelioma

European Lung Cancer Working Party

Status and phase: Completed; Phase 2

Conditions: Malignant Mesothelioma

Treatments: Drug: Valproate plus doxorubicin

Study type: Interventional

Funder types: Other

Identifiers

NCT00634205

ELCWP-01062

Details and patient eligibility

About

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 .

Enrollment: 45 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

45 participants in 1 patient group

A

Experimental group

Description:

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

Treatment:

Drug: Valproate plus doxorubicin