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Posted on Saturday, Mar 1, 2008

Phase II Study of Valproate and Doxorubicin in Malignant Mesothelioma

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…

Date First Received: March 5, 2008
Last Updated: March 5, 2008
Verified by: European Lung Cancer Working Party, March 2008
Clinical Trial Phase: Phase 2 | Start Date: July 2006
Overall Status: Recruiting
Estimated Enrollment: 41

Brief Summary

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

Condition Keyword(s):

  • Malignant MesotheliomaIntervention(s):
  • Drug: Valproate plus doxorubicin

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.

Study Type: Interventional

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

Outcome Measures for this Clinical
Trial

Primary:

  • Response rate Every 3 courses

Secondary:

  • Survival Survival will be dated from the day of registration until death or last follow up
  • Toxicity After each course of chemotherapy and at the end of treatment

Criteria for Participation in this Clinical Trial

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
  • Transaminasesmore 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

Clinical Trials Locations, Contact Details, and Sponsors

  • Lead Sponsor: European Lung Cancer Working Party
  • Department of Intensive Care Unit and Thoracic Oncology Institut Jules
    Bordet
    Brussels 1000 Belgium
  • Department of
    Pneumology CHU Charleroi
    Charleroi 6000 Belgium
  • Department of Pneumology Hôpital Saint-Joseph
    Gilly
    6060 Belgium
  • Department of Pneumology CHR St joseph
    - Warquignies
    Boussu 7360 Belgium
  • CH Peltzer-La
    Tourelle
    Verviers 4800 Belgium
  • Hôpital
    Ambroise Paré
    Mons 7000 Belgium
  • Department of
    Pneumology Hôpital Ixelles-Molière
    Brussels Belgium
  • Department of Pneumology CHRU Lille
    Lille France
  • Overall Clinical Trial Officials and Contacts
  • Thierry Berghmans, MD Study Chair European Lung Cancer
    Working PartyOverall Contact: Nathalie Leclercq,
    RN 0032/2/5390496
    nathalie.leclercq@bordet.be

Additional Information

  • Information obtained from ClinicalTrials.gov on April 29, 2008
  • Link to the current ClinicalTrials.gov record: http://clinicaltrials.gov/show/NCT00634205
  • Study ID Number: ELCWP-01062
  • ClinicalTrials.gov Identifier: NCT00634205
  • Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products
    Click here for more information on the protocol
  • Trials registry of the French National Cancer Institute
  • Clinical Trials Authorship and Review
  • Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.