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Phase II Study of Valproate and Doxorubicin in Malignant Mesothelioma

Primary Purpose

Malignant Mesothelioma

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Valproate plus doxorubicin
Sponsored by
European Lung Cancer Working Party
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malignant Mesothelioma focused on measuring Mesothelioma, Valproate, Doxorubicin, Chemotherapy, Phase II

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Department of Pneumology CHR St joseph - Warquignies
  • Department of Intensive Care Unit and Thoracic Oncology Institut Jules Bordet
  • Department of Pneumology Hôpital Ixelles-Molière
  • Department of Pneumology CHU Charleroi
  • Department of Pneumology Hôpital Saint-Joseph
  • Hôpital Ambroise Paré
  • CH Peltzer-La Tourelle
  • Department of Pneumology CHRU Lille

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

A

Arm Description

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

Outcomes

Primary Outcome Measures

Response rate

Secondary Outcome Measures

Survival
Toxicity

Full Information

First Posted
March 5, 2008
Last Updated
February 11, 2015
Sponsor
European Lung Cancer Working Party
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1. Study Identification

Unique Protocol Identification Number
NCT00634205
Brief Title
Phase II Study of Valproate and Doxorubicin in Malignant Mesothelioma
Official Title
A Phase II Study Assessing the Activity of Valproate Acid Plus Doxorubicin in Refractory or Recurrent Malignant Mesothelioma
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
June 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
European Lung Cancer Working Party

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Mesothelioma
Keywords
Mesothelioma, Valproate, Doxorubicin, Chemotherapy, Phase II

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
Continuous oral administration of valproate plus every 3 weeks, intravenous administration of doxorubicin
Intervention Type
Drug
Intervention Name(s)
Valproate plus doxorubicin
Intervention Description
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
Primary Outcome Measure Information:
Title
Response rate
Time Frame
Every 3 courses
Secondary Outcome Measure Information:
Title
Survival
Time Frame
Survival will be dated from the day of registration until death or last follow up
Title
Toxicity
Time Frame
After each course of chemotherapy and at the end of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thierry Berghmans, MD
Organizational Affiliation
European Lung Cancer Working Party
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Pneumology CHR St joseph - Warquignies
City
Boussu
ZIP/Postal Code
7360
Country
Belgium
Facility Name
Department of Intensive Care Unit and Thoracic Oncology Institut Jules Bordet
City
Brussels
ZIP/Postal Code
1000
Country
Belgium
Facility Name
Department of Pneumology Hôpital Ixelles-Molière
City
Brussels
Country
Belgium
Facility Name
Department of Pneumology CHU Charleroi
City
Charleroi
ZIP/Postal Code
6000
Country
Belgium
Facility Name
Department of Pneumology Hôpital Saint-Joseph
City
Gilly
ZIP/Postal Code
6060
Country
Belgium
Facility Name
Hôpital Ambroise Paré
City
Mons
ZIP/Postal Code
7000
Country
Belgium
Facility Name
CH Peltzer-La Tourelle
City
Verviers
ZIP/Postal Code
4800
Country
Belgium
Facility Name
Department of Pneumology CHRU Lille
City
Lille
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
20530048
Citation
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.
Results Reference
derived
Links:
URL
http://www.e-cancer.fr
Description
Trials registry of the French National Cancer Institute

Learn more about this trial

Phase II Study of Valproate and Doxorubicin in Malignant Mesothelioma

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