Clinical trial · Interventional
A Study of Cetuximab Combined With Cisplatin or Carboplatin/Pemetrexed as First Line Treatment in Patients With Malignant Pleural Mesothelioma.
Phase II Study of Cetuximab Combined With Cisplatin or Carboplatin/Pemetrexed as First Line Treatment in Patients With Malignant Pleural Mesothelioma.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cetuximab (Erbitux) | Drug | Cetuximab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Cetuximab (Erbitux)
- interventionNames
- Drug: Cetuximab (Erbitux)
Primary outcomes (1)
- measure
- Progression fee survival rate
- timeFrame
- At 18 weeks
Secondary outcomes (3)
- measure
- Response rate according to modified RECIST criteria
- timeFrame
- every 6 weeks until progression
- measure
- Toxicity (CTCAE version 4)
- timeFrame
- weekly during treatment and follow-up of AE's until 30 days after last dosis
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available