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

This study is currently recruiting participants.
Verified September 2012 by University Hospital, Ghent
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT00996567
First received: October 15, 2009
Last updated: September 13, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention Phase
Cancer
Drug: Cetuximab (Erbitux)
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Cetuximab Combined With Cisplatin or Carboplatin/Pemetrexed as First Line Treatment in Patients With Malignant Pleural Mesothelioma.

Resource links provided by NLM:


Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:
  • Progression fee survival rate [ Time Frame: At 18 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Response rate according to modified RECIST criteria [ Time Frame: every 6 weeks until progression ] [ Designated as safety issue: No ]
  • Toxicity (CTCAE version 4) [ Time Frame: weekly during treatment and follow-up of AE's until 30 days after last dosis ] [ Designated as safety issue: Yes ]
  • Overall survival [ Time Frame: average survival of 9 - 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 18
Study Start Date: October 2009
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cetuximab (Erbitux) Drug: Cetuximab (Erbitux)
Patients will be treated with standard chemotherapy (4-6 cycles), combined with weekly administration of Cetuximab (Erbitux) until disease progression.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00996567

Contacts
Contact: Veerle Surmont, MD veerle.surmont@uzgent.be

Locations
Belgium
UZ Antwerpen Recruiting
Antwerpen, Belgium
Principal Investigator: Dr. Germonprez         
University Hospital Ghent Recruiting
Ghent, Belgium, 9000
Contact: Veerle Surmont, MD       veerle.surmont@uzgent.be   
Principal Investigator: Veerle Surmont, MD         
AZ St. Maarten Recruiting
Mechelen, Belgium, 2800
Contact: Lambrechts, MD         
Principal Investigator: Lambrechts, MD         
Netherlands
AMC Heerlen Recruiting
Heerlen, Netherlands
Principal Investigator: Dr. Bootsma         
Sponsors and Collaborators
University Hospital, Ghent
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Veerle Surmont, MD University Hospital, Ghent
  More Information

Additional Information:
No publications provided

Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT00996567     History of Changes
Other Study ID Numbers: 2009/337
Study First Received: October 15, 2009
Last Updated: September 13, 2012
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products
Belgium: Institutional Review Board

Keywords provided by University Hospital, Ghent:
Malignant mesothelioma

Additional relevant MeSH terms:
Mesothelioma
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Mesothelial
Pemetrexed
Cetuximab
Cisplatin
Carboplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Antimetabolites, Antineoplastic
Antimetabolites

ClinicalTrials.gov processed this record on April 17, 2014