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

Cancer Clinical Trial

— MesoMab  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00996567
• Other study ID #: 2009/337
• Status: Completed
• Phase: Phase 2
• First received: October 15, 2009
• Last updated: February 7, 2017
• Start date: October 2009
• Est. completion date: September 2015

Study information

• Verified date: February 2017
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Mesothelioma

Intervention

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

Locations

Country	Name	City	State
Belgium	UZ Antwerpen	Antwerpen
Belgium	University Hospital Ghent	Ghent
Belgium	AZ St. Maarten	Mechelen
Netherlands	AMC Heerlen	Heerlen

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Ghent	Merck Sharp & Dohme Corp.

Countries where clinical trial is conducted

Belgium,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression fee survival rate		At 18 weeks
Secondary	Response rate according to modified RECIST criteria		every 6 weeks until progression
Secondary	Toxicity (CTCAE version 4)		weekly during treatment and follow-up of AE's until 30 days after last dosis
Secondary	Overall survival		average survival of 9 - 12 months

External Links

•   website of the University Hospital Ghent