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. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 22, 2014