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A Study of Cetuximab Combined With Cisplatin or Carboplatin/Pemetrexed as First Line Treatment in Patients With Malignant Pleural Mesothelioma. (MesoMab)

Primary Purpose

Cancer

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Cetuximab (Erbitux)
Sponsored by
University Hospital, Ghent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cancer focused on measuring Malignant mesothelioma

Eligibility Criteria

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

Inclusion Criteria:

  • Histologically proven malignant pleural mesothelioma, epitheloid subtype
  • Recurrent after radical surgery or disease not considered suitable for radical treatment
  • EGFR IHC + as assessed by DAKO kit with at least 1% of cells showing staining
  • Performance status WHO 0 or 1
  • Life expectancy > 12 weeks
  • Weight loss < 10% in last 3 months
  • Adequate bone marrow reserve, renal and hepatic function
  • Measurable disease (modified RECIST)
  • No prior chemotherapy
  • No prior or other malignancies, except if longer than 5 yrs ago and adequately treated or basocellular skin or in situ cervical cancer
  • No uncontrolled infection
  • Written informed consent.
  • Male/Female
  • > 18 years

Exclusion Criteria:

  • Evidence of brain or leptomeningeal metastases
  • Patients who are unable to interrupt aspirin, other nonsteroidal anti-inflammatory drugs for a 5-day period starting 2 days before administration of pemetrexed (8-day period for long acting agents such as piroxicam)
  • Patients that cannot be treated with folic acid and vitamin B 12
  • Patients that cannot be treated with dexamethasone.
  • Presence of clinically detectable (by physical examination) third-space fluid collections, for example ascites of pleural effusions that cannot be controlled by drainage or other procedures prior to the study entry.
  • Use of investigational drugs

Sites / Locations

  • UZ Antwerpen
  • University Hospital Ghent
  • AZ St. Maarten
  • AMC Heerlen

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cetuximab (Erbitux)

Arm Description

Outcomes

Primary Outcome Measures

Progression fee survival rate

Secondary Outcome Measures

Response rate according to modified RECIST criteria
Toxicity (CTCAE version 4)
Overall survival

Full Information

First Posted
October 15, 2009
Last Updated
February 7, 2017
Sponsor
University Hospital, Ghent
Collaborators
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT00996567
Brief Title
A Study of Cetuximab Combined With Cisplatin or Carboplatin/Pemetrexed as First Line Treatment in Patients With Malignant Pleural Mesothelioma.
Acronym
MesoMab
Official Title
Phase II Study of Cetuximab Combined With Cisplatin or Carboplatin/Pemetrexed as First Line Treatment in Patients With Malignant Pleural Mesothelioma.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Ghent
Collaborators
Merck Sharp & Dohme LLC

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Multicenter, open phase 2 study on patients with malignant mesothelioma. Standardly, 4 to 6 cycles of palliative chemotherapy, platinum in combination with pemetrexed, are given. Despite of this treatment, median survival is poor (9-12 months). By combining conventional cytotoxic agents with a novel agent, hopefully treatment and survival can be approved. Cetuximab or Erbitux is a monoclonal antibody against the EGFR (Epidermal Growth Factor Receptor). By blocking the receptor, it interferes with cel growth and division. Most mesothelioma show a strong expression of the EGFR protein. Apart from that, Cetuximab also has antibody-dependent cell-mediated cytotoxicity (ADCC). In this trial, patients will be treated with standard chemotherapy, combined with Cetuximab weekly. After a maximum of 6 cycles of chemotherapy, administration of Cetuximab will be continued until disease progression. Every 6 weeks, a CT scan will be done to evaluate therapy. Most common side effect of Cetuximab is acneiform rash. The translation research program consists of the determination of EGFR- and K-Ras mutations on the tumor tissue and the correlation with outcome. In the first part of the trial, 18 patients will be included. After a positive interim analysis, a total of 43 patients will be included.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer
Keywords
Malignant mesothelioma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cetuximab (Erbitux)
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Cetuximab (Erbitux)
Intervention Description
Patients will be treated with standard chemotherapy (4-6 cycles), combined with weekly administration of Cetuximab (Erbitux) until disease progression.
Primary Outcome Measure Information:
Title
Progression fee survival rate
Time Frame
At 18 weeks
Secondary Outcome Measure Information:
Title
Response rate according to modified RECIST criteria
Time Frame
every 6 weeks until progression
Title
Toxicity (CTCAE version 4)
Time Frame
weekly during treatment and follow-up of AE's until 30 days after last dosis
Title
Overall survival
Time Frame
average survival of 9 - 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically proven malignant pleural mesothelioma, epitheloid subtype Recurrent after radical surgery or disease not considered suitable for radical treatment EGFR IHC + as assessed by DAKO kit with at least 1% of cells showing staining Performance status WHO 0 or 1 Life expectancy > 12 weeks Weight loss < 10% in last 3 months Adequate bone marrow reserve, renal and hepatic function Measurable disease (modified RECIST) No prior chemotherapy No prior or other malignancies, except if longer than 5 yrs ago and adequately treated or basocellular skin or in situ cervical cancer No uncontrolled infection Written informed consent. Male/Female > 18 years Exclusion Criteria: Evidence of brain or leptomeningeal metastases Patients who are unable to interrupt aspirin, other nonsteroidal anti-inflammatory drugs for a 5-day period starting 2 days before administration of pemetrexed (8-day period for long acting agents such as piroxicam) Patients that cannot be treated with folic acid and vitamin B 12 Patients that cannot be treated with dexamethasone. Presence of clinically detectable (by physical examination) third-space fluid collections, for example ascites of pleural effusions that cannot be controlled by drainage or other procedures prior to the study entry. Use of investigational drugs
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Veerle Surmont, MD
Organizational Affiliation
University Hospital, Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
UZ Antwerpen
City
Antwerpen
Country
Belgium
Facility Name
University Hospital Ghent
City
Ghent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
AZ St. Maarten
City
Mechelen
ZIP/Postal Code
2800
Country
Belgium
Facility Name
AMC Heerlen
City
Heerlen
Country
Netherlands

12. IPD Sharing Statement

Links:
URL
http://www.uzgent.be
Description
website of the University Hospital Ghent

Learn more about this trial

A Study of Cetuximab Combined With Cisplatin or Carboplatin/Pemetrexed as First Line Treatment in Patients With Malignant Pleural Mesothelioma.

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