A Study of Cetuximab Combined With Cisplatin or Carboplatin/Pemetrexed as First Line Treatment in Patients With Malignant Pleural Mesothelioma.
Conditions
Cancer
Conditions: official terms
Mesothelioma
Conditions: Keywords
Malignant mesothelioma
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Cetuximab (Erbitux)
Type: Drug
Overall Status
Recruiting
Summary
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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
Locations
UZ Antwerpen
Antwerpen, Belgium
Status: Recruiting
University Hospital Ghent
Ghent, Belgium
Status: Recruiting
Contact: Veerle Surmont, MD - veerle.surmont@uzgent.be
AZ St. Maarten
Mechelen, Belgium
Status: Recruiting
Contact: Lambrechts, MD
AMC Heerlen
Heerlen, Netherlands
Status: Recruiting
Start Date
October 2009
Completion Date
September 2015
Sponsors
University Hospital, Ghent
Source
University Hospital, Ghent
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page