Phase III Clinical Trials

There are currently only three phase III (or phase II/III) clinical trails for mesothelioma listed in the National Cancer Institute trial database. Most of the location are in Europe with the one exception being a Pennsylvania trial. The trials are listed below for your convenience.

Search Criteria:

Cancer Type/Condition: Mesothelioma
Trial Type: Treatment
Trial Status: Active
Trial Phase: Phase IV, Phase III

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Trial Listings

1. Vorinostat (MK0683, SAHA) Versus Placebo in Advanced Malignant Pleural Mesothelioma
Phase Type Status Age Sponsor Protocol IDs
Phase III, Phase II Treatment Active 18 and over Pharmaceutical / Industry 2005_010
MK0683-014, NCT00128102

Trial Description

Summary

This is a Phase III a study which incorporates an initial Phase II component to determine the safety, tolerability, and anti-tumor effectiveness of an oral investigational drug suberoylanilide hydroxamic acid, in the treatment of advanced malignant pleural Mesothelioma.

Revised (20-Dec-2007)

Eligibility Criteria

Inclusion Criteria:

Patient must be 18 years or older with confirmed diagnosis of malignant pleural mesothelioma.
Patient must have failed prior chemotherapy that included pemetrexed with either cisplatin or carboplatin.
Patient must have adequate bone marrow, liver and kidney function.
Patient must be capable of self-care and out of bed for more than 50% of waking hours.
Patient must have ability to swallow pills.
Exclusion Criteria:

Patient has been treated with other investigational agent that has similar properties
Patient has an active infection within 2 weeks of the start of study drug, or had treatment with intravenous antibiotic, antiviral, or antifungal medications within 2 weeks of the start of study drug.
Patient is pregnant or breast feeding
Trial Contact Information

Trial Lead Organizations/Sponsors

Merck and Company, Incorporated

Medical Monitor Study Director

Toll Free Number Ph: 1-888-577-8839

Trial Sites

U.S.A.

Pennsylvania

Pittsburgh

Call for Information

Belgium

Bruxelles

Merck Sharp & Dohme Limited

Nathalie Schrameijer Ph: 32-2-373-4310

Brazil

Sao Paulo

Sao Paulo

Merck Sharp & Dohme Farmaceutica Ltda.

Jose Octavio P. Costa Filo Ph: 55-11-5189-7942

Germany

Haar

Merck Sharp & Dohme GmbH - Germany

Thomas Lang Ph: 49-89-4561-1536

Italy

Roma

Merck Sharp and Dohme - Rome

Gianfranco Botta Ph: 39 06 36 191187

Netherlands

Haarlem

Merck Sharp & Dohme B.V.

Gerard Van Leijenhorst Ph: 31 23 515 3306

New Zealand

Auckland

Merck Sharp and Dohme New Zealand LTD

David Woolner Ph: 64-9523-6075

Spain

Madrid

Merck Sharp and Dohme de Espana, SA

Jorge Gonzalez-Esteban Ph: 34 91 3210726

Sweden

Sollentuna

Merck Sharp & Dohme (Sweden) AB

Roger Juhlin Ph: 46-8-626-1 458

United Kingdom

Hoddesdon

Merck Sharp & Dohme Limited - United Kingdom

Paul Robinson Ph: 44 1992 452341

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2. Mesothelioma Avastin Plus Pemetrexed-Cisplatin Study
Phase Type Status Age Sponsor Protocol IDs
Phase III, Phase II Treatment Active 18 to 75 Other IFCT-GFPC-ELCWP-0701
NCT00651456

Trial Description

Summary

Our hypothesis is that the addition of bevacizumab to the standard chemotherapy treatment of MPM will improve overall survival and quality of life beyond that achieved with chemotherapy alone.

Further Study Information

A phase II trial associating the reference chemotherapy (pemetrexed plus cisplatin) with bevacizumab is needed to ensure that no specific toxicity is induced by this association, and that this triplet have interesting activity.

As pleural mesothélioma is a rare tumor, a phase III trial, using the survival data from the phase II part study, will be able to include a sufficient number of patients, in a reasonable period of time, to answer the question of efficacy of the anti-angiogenic triplet, providing the efficacy outcomes could be considered as favorable, at the end of the phase II part of the study.

Eligibility Criteria

Inclusion Criteria:

Malignant, histologically proved, non resectable pleural Mesothelioma
In case of pleural effusion, a talc pleurodesis, although not recommended, is allowed in accordance with current local practice, at the time of diagnostic thorascopy, with inclusion CT scan performed after pleurodesis.
ECOG Performance status 0-2
Mesothelioma with only pleural effusion without uni- or bidimensionally measurable disease will be eligible (adapted RECIST criteria)
At least 18 years of age, less than 76 years of age
Radiation therapy of thoracocentis tract (3 x 7Gy) performed before beginning medical study treatment, and the interval between thoracoscopic procedure and radiation will not exceed 28 days
Exclusion Criteria:

Prior chemotherapy
Brain metastasis
History of cerebral vascular accident (CVA) or transient ischemic attack
Trial Contact Information

Trial Lead Organizations/Sponsors

French Thoracic Oncology Intergroup Center

CHU de Caen

Groupe Francais de Pneumo-Cancerologie

European Lung Cancer Working Party

Gilles Robinet, Dr Study Director

Arnaud Scherpereel, Dr Study Director

Gérard Zalcman, Pr Ph: 33-2-31-06-44-76

Franck Morin
Email: franck.morin@ifct.fr

Trial Sites

Belgium

BRUXELLES

Institut Jules Bordet

Thierry Berghmans, Dr Ph: +32 25 41 31 11

France

Belfort

Centre Hospitalier - Pneumologie

Jean-Luc Breton, Dr Ph: +33 3 84 98 51 18

Besancon

Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz

Pascale Jacoulet, Dr

CAEN

CHU de Caen

Gerard Zalcman, Pr

Clamart

Hopital d'Instruction des Armees Percy

Jacques Margery, Dr

Grenoble

CHU de Grenoble - Hopital de la Tronche

Denis Moro-Sibilot, Pr

Denis Moro-Sibilot, Pr Principal Investigator

Le Havre

Centre Hospitalier - Pneumologie

Philippe Hubscher, Dr

Le Mans

Centre Hospitalier - Pneumologie

Francois-Xavier Lebas, Dr

Olivier Molinier, Dr

Lille

CHU (Hôpital Calmette) - Pneumologie

Arnaud Scherpereel, Dr

LYON

HCL - Croix-Rousse

Maurice Pérol, Dr

Marseille

Hopital Sainte Marguerite

Philippe ASTOUL, Pr

PARIS

Hopital Tenon

Bernard MILLERON, Dr

Pierre Bénite

Centre Hospitalier Lyon Sud

Pierre-Jean Souquet, Dr

Strasbourg

Hopital Lyautey

Elisabeth Quoix, Pr

Elisabeth Quoix, Pr Principal Investigator

Toulouse

CHU de Toulouse, Hotel Dieu

Julien Mazieres, Pr

VILLEJUIF

Institut Gustave Roussy

Pierre Ruffié, Dr Ph: +33 1 42 11 42 11

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3. Video-Assisted Surgery or Talc Pleurodesis in Treating Patients With Malignant Mesothelioma

First Published: 1/12/2009
Alternate Title
Phase III Randomized Study of Video-Assisted Thoracoscopic Cytoreductive Pleurectomy Versus Talc Pleurodesis in Patients With Suspected or Proven Malignant Mesothelioma

Phase Type Status Age Sponsor Protocol IDs
Phase III Treatment Active 18 and over Other PAPWORTH-MESOVAT
MESOVAT, PAPWORTH-P00804, EU-20901, ISRCTN34321019, NCT00821860

Trial Description

Purpose:

Video-assisted surgery to remove part of the tissue layer covering the inside of the chest cavity may be effective in treating pleural effusion and cause less damage to normal tissue. Talc pleurodesis may keep fluid from building up in the chest cavity. It is not yet known which therapy is more effective in treating pleural effusion caused by malignant mesothelioma.

This randomized phase III trial is studying video-assisted surgery to see how well it works compared with talc pleurodesis in treating patients with malignant mesothelioma.

Eligibility:

Eligibility criteria include the following:

At least 18 years old
Has a pleural effusion
No previous pleurodesis
For more information about the eligibility criteria for this trial, refer to the Health Professional version.
Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Treatment/Intervention:

Patients will be randomly assigned (have an equal chance of being placed) to one of two treatment groups.

Patients in group one will undergo video-assisted surgery at biopsy or at a later time.

Patients in group two will undergo talc pleurodesis at biopsy or at a later time.

Quality of life will be assessed at the beginning of the study and at 1, 3, 6, and 12 months.

Trial Contact Information

Trial Lead Organizations

Papworth Hospital

Robert Winter, MD, Principal investigator Ph: 44-1480-364-821

Trial Sites

United Kingdom

England

Basildon

Basildon University Hospital

Contact Person Ph: 44-1268-533-911

Cambridge

Papworth Hospital

Contact Person Ph: 44-1480-364-821

Leicester

Glenfield Hospital

Contact Person Ph: 44-116-287-1471

London

Guy's Hospital

Contact Person Ph: 44-20-7188-7188

Sheffield

Royal Hallamshire Hospital

Contact Person Ph: 44-114-271-1900