NCT00634205

Brief 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 .

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jul 2006

Typical duration for phase_2

Geographic Reach
2 countries

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2006

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

March 5, 2008

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 12, 2008

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

February 12, 2015

Status Verified

February 1, 2015

Enrollment Period

2.7 years

First QC Date

March 5, 2008

Last Update Submit

February 11, 2015

Conditions

Malignant Mesothelioma

Keywords

MesotheliomaValproateDoxorubicinChemotherapyPhase II

Outcome Measures

Primary Outcomes (1)

  • Response rate

    Every 3 courses

Secondary Outcomes (2)

  • 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

Study Arms (1)

A

EXPERIMENTAL

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

Drug: Valproate plus doxorubicin

Interventions

Valproate plus doxorubicinDRUG

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

A

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Department of Pneumology CHR St joseph - Warquignies

Boussu, 7360, Belgium

Location

Department of Intensive Care Unit and Thoracic Oncology Institut Jules Bordet

Brussels, 1000, Belgium

Location

Department of Pneumology Hôpital Ixelles-Molière

Brussels, Belgium

Location

Department of Pneumology CHU Charleroi

Charleroi, 6000, Belgium

Location

Department of Pneumology Hôpital Saint-Joseph

Gilly, 6060, Belgium

Location

Hôpital Ambroise Paré

Mons, 7000, Belgium

Location

CH Peltzer-La Tourelle

Verviers, 4800, Belgium

Location

Department of Pneumology CHRU Lille

Lille, France

Location

Related Publications (1)

  • Scherpereel A, Berghmans T, Lafitte JJ, Colinet B, Richez M, Bonduelle Y, Meert AP, Dhalluin X, Leclercq N, Paesmans M, Willems L, Sculier JP; European Lung Cancer Working Party (ELCWP). Valproate-doxorubicin: promising therapy for progressing mesothelioma. A phase II study. Eur Respir J. 2011 Jan;37(1):129-35. doi: 10.1183/09031936.00037310. Epub 2010 Jun 7.

    PMID: 20530048DERIVED

Related Links

MeSH Terms

Conditions

Mesothelioma, MalignantMesothelioma

Interventions

Valproic AcidDoxorubicin

Condition Hierarchy (Ancestors)

AdenomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, MesothelialLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SitePleural NeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Pentanoic AcidsValeratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsFatty Acids, VolatileFatty AcidsLipidsDaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydrates

Study Officials

  • Thierry Berghmans, MD

    European Lung Cancer Working Party

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 5, 2008

First Posted

March 12, 2008

Study Start

July 1, 2006

Primary Completion

March 1, 2009

Study Completion

June 1, 2010

Last Updated

February 12, 2015

Record last verified: 2015-02

Locations

FR(1)BE(7)