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

NCT ID: NCT00996567

Last Updated: 2017-02-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2015-09-30

Brief 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.

Conditions

Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cetuximab (Erbitux)

Group Type: EXPERIMENTAL

Cetuximab (Erbitux)

Intervention Type: DRUG

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

Interventions

Cetuximab (Erbitux)

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

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

University Hospital, Ghent

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Veerle Surmont, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Ghent

Locations

UZ Antwerpen

Antwerp, , Belgium

University Hospital Ghent

Ghent, , Belgium

AZ St. Maarten

Mechelen, , Belgium

AMC Heerlen

Heerlen, , Netherlands

Countries

Belgium; Netherlands

Related Links

http://www.uzgent.be

website of the University Hospital Ghent

Other Identifiers

2009/337

Identifier Type: -

Identifier Source: org_study_id