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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)

This study has been completed.
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: February 7, 2017
Last verified: February 2017
  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: Intervention Model: Single Group Assignment
Masking: No masking
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 ]

Secondary Outcome Measures:
  • Response rate according to modified RECIST criteria [ Time Frame: every 6 weeks until progression ]
  • Toxicity (CTCAE version 4) [ Time Frame: weekly during treatment and follow-up of AE's until 30 days after last dosis ]
  • Overall survival [ Time Frame: average survival of 9 - 12 months ]

Enrollment: 22
Study Start Date: October 2009
Study Completion Date: September 2015
Primary Completion Date: September 2015 (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   (Adult, Senior)
Sexes Eligible for Study:   All
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

Locations
Belgium
UZ Antwerpen
Antwerpen, Belgium
University Hospital Ghent
Ghent, Belgium, 9000
AZ St. Maarten
Mechelen, Belgium, 2800
Netherlands
AMC Heerlen
Heerlen, Netherlands
Sponsors and Collaborators
University Hospital, Ghent
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Veerle Surmont, MD University Hospital, Ghent
  More Information

Additional Information:
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: February 7, 2017

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
Cisplatin
Cetuximab
Carboplatin
Pemetrexed
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on May 25, 2017