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NCT Number: NCT00996567

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

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.

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Key information

Conditions

Cancer Adenoma Lung Diseases Lung Neoplasms Mesothelioma Mesothelioma, Malignant Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neoplasms, Mesothelial Pleural Neoplasms Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

UZ Antwerpen, Antwerp, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cetuximab (Erbitux)

Drug

Patients will be treated with standard chemotherapy (4-6 cycles), combined with weekly administration of Cetuximab (Erbitux) until disease progression.

Primary outcomes

  1. Progression fee survival rate

    Time frame: At 18 weeks

Secondary outcomes

  1. Response rate according to modified RECIST criteria

    Time frame: every 6 weeks until progression

  2. Toxicity (CTCAE version 4)

    Time frame: weekly during treatment and follow-up of AE's until 30 days after last dosis

  3. Overall survival

    Time frame: average survival of 9 - 12 months

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Official study title

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

Acronym: MesoMab

Important dates

Study start
2009
Primary completion
2015
Study completion
2015
First posted
Oct 16, 2009
Registry last updated
Feb 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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