Phase II study of cetuximab combined with cisplatin or carboplatin/pemetrexed as first line treatment in patients with malignant pleural mesothelioma.

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-014293-17-NL

Enrollment

Registered

2010-06-24

Start date

2011-05-09

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with malignant pleural mesothelioma MedDRA version: 13.1 Level: PT Classification code 10059518 Term: Pleural mesothelioma malignant System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Interventions

Trade Name: Erbitux Product Name: Cetuximab Pharmaceutical Form: Solution for infusion INN or Proposed INN: Cetuximab CAS Number: 205923564 Concentration unit: mg/ml milligram(s)/millilitre Concentrat

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Histological 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 1.5 x 109 /L, platelets > 100 x 109/L) - Creatinine clearance: > 60 mL/min (Cockroft and Gault) or > 50 mL/min (51Cr-EDTA) - Adequate hepatobiliary function (ALT/AST) =65 years) yes F.1.3.1 Number of subjects for this age range 5

Exclusion criteria

Exclusion criteria: - Evidence of brain or leptomeningeal metastases - Patients with pre-existing peripheral neuropathy - Patients who are unable to interrupt aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs), other than aspirin dose = 1,3 grams per day, for at least 2 days (5 days for long-acting agents, for example Piroxicam) before, during and for at least 2 days after administration of pemetrexed - Patients that cannot be treated with folic acid and vit B 12 - Patients that cannot be treated with dexamethasone. - Presence of clinically detectable (by physical examination) third-space fluid collections, for example ascites or pleural effusions that cannot be controlled by drainage or other procedures prior to the study entry. - Use of investigational drugs - Patients who are pregnant, breast feeding or unwilling to use adequate contraception

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate the activity and safety of the combination of cetuximab and platinum/pemetrexed as first line treatment in EGFR IHC positive mesothelioma patients.;Secondary Objective: To perform a translational research program to evaluate the possible use of EGFR FISH and K-ras mutations and other biomarkers to predict response to cetuximab in patients with MPM.;Primary end point(s): Progression free survival rate (PFSR) at 18 weeks.;Timepoint(s) of evaluation of this end point: At 18 weeks	—

Measure

Time frame

Main Objective: To investigate the activity and safety of the combination of cetuximab and platinum/pemetrexed as first line treatment in EGFR IHC positive mesothelioma patients.;Secondary Objective: To perform a translational research program to evaluate the possible use of EGFR FISH and K-ras mutations and other biomarkers to predict response to cetuximab in patients with MPM.;Primary end point(s): Progression free survival rate (PFSR) at 18 weeks.;Timepoint(s) of evaluation of this end point: At 18 weeks

—

Secondary

Measure	Time frame
Secondary end point(s): - Response rate according to modified RECIST criteria - Toxicity (CTCAE version 4) - Overall survival ;Timepoint(s) of evaluation of this end point: At 18 weeks	—

Countries

Netherlands

Contacts

Public ContactGerben P. Bootsma

Atrium MC Parkstad

GBA02@atriummc.nl31455767778

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026