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

Phase 1

• Conditions: Patients with malignant pleural mesothelioma; MedDRA version: 12.0Level: LLTClassification code 10059518Term: Pleural mesothelioma malignant

• Registration Number: EUCTR2009-014293-17-BE
• Lead Sponsor: niversity Hospital Ghent

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07-27
• Last Update Posted: 21 August 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 18

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 < 10% in last 3 months
- Adequate bone marrow reserve (ANC count > 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) < 2.5 x upper limit of normal range (ULN) or < 5 x ULN for patients with liver metastases, bilirubin < 1.5 x ULN)
- Measurable disease (modified RECIST, see Section X on evaluation of response)
- 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
- Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
- Written informed consent according to ICH/GCP, and national/local regulations
- age of 18 years or older
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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, 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 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
- Female patients who are lactating or child bearing potential without adequate contraceptive measures

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified