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Clinical Trial Details

Overview

Research Study Summary

A clinical trial seeking patients for a research study for the treatment of Cancer

Research Study Title

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

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.

To Learn more
Phase

2

Gender

Both Male and Female

Age

18 and up

Overall Status

Recruiting

Lead Sponsor

University Hospital, Ghent

Duration

71 Months

Facility Type

N/A

Eligibility

Both Male and Female ages 18 Years and up

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

Site Locations (4)

Country State City Zip Facility and Contact
Belgium Antwerpen UZ Antwerpen

Dr. Germonprez
Principal Investigator
Belgium Ghent 9000 University Hospital Ghent
Veerle Surmont, MD
veerle.surmont@uzgent.be

Veerle Surmont, MD
Principal Investigator
Belgium Mechelen 2800 AZ St. Maarten
Lambrechts, MD

Lambrechts, MD
Principal Investigator
Netherlands Heerlen AMC Heerlen

Dr. Bootsma
Principal Investigator

Contact

Veerle Surmont, MD

E-mail:

NCT ID: NCT00996567

Date Last Changed: December 4, 2014

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