Phase II study of Cetuximab combined with Cisplatin or Carboplatin/Pemetrexed as first line treatment in patients with malignant pleural mesothelioma

Phase 2

Completed

• Conditions: 10027412; malignant mesothelioma or cancer of the mesothelium

• Registration Number: NL-OMON34616
• Lead Sponsor: Atrium MC Heerlen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 10

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
- Pregnant or lactating women

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Progression fee survival rate at 18 weeks</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Response rate according to modified RECIST criteria<br /><br>- Toxicity (CTCAE version 4)<br /><br>- Overall survival</p><br>