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| Sponsored by: |
European Lung Cancer Working Party |
| Information provided by: | European Lung Cancer Working Party |
| ClinicalTrials.gov Identifier: | NCT00634205 |
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 |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Nathalie Leclercq, RN | 0032/2/5390496 | nathalie.leclercq@bordet.be |
| Contact: Thierry Berghmans, MD | 0032/2/5413111 |
| 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 | |||||
| European Lung Cancer Working Party |
| Study Chair: | Thierry Berghmans, MD | European Lung Cancer Working Party |
More Information
Click here for more information on the protocol 
  |
Trials registry of the French National Cancer Institute 
  |
| 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 |
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