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

NCT00996567 | Completed Phase 2

• 1 other identifier: 2009/337
• Study Type: interventional
• Target: 22
• Locations: 2 countries
• Sites: 4

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

Keywords

Malignant mesothelioma

Outcome Measures

Primary Outcomes (1)

• Progression fee survival rate

  At 18 weeks

Secondary Outcomes (3)

• Response rate according to modified RECIST criteria

  every 6 weeks until progression

• Toxicity (CTCAE version 4)

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

• Overall survival

  average survival of 9 - 12 months

Study Arms (1)

Cetuximab (Erbitux)

EXPERIMENTAL

Drug: Cetuximab (Erbitux)

Interventions

Cetuximab (Erbitux) DRUG

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

Cetuximab (Erbitux)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Ghent: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (4)

UZ Antwerpen

Antwerp, Belgium

Location

University Hospital Ghent

Ghent, 9000, Belgium

Location

AZ St. Maarten

Mechelen, 2800, Belgium

Location

AMC Heerlen

Heerlen, Netherlands

Location

Related Links

• website of the University Hospital Ghent

MeSH Terms

Conditions

Neoplasms; Mesothelioma, Malignant

Interventions

Cetuximab

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Veerle Surmont, MD

  University Hospital, Ghent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2009
• First Posted: October 16, 2009
• Study Start: October 1, 2009
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: February 9, 2017

Record last verified: 2017-02

Locations

BE (3); NL (1)