- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00996567
A Study of Cetuximab Combined With Cisplatin or Carboplatin/Pemetrexed as First Line Treatment in Patients With Malignant Pleural Mesothelioma. (MesoMab)
Phase II Study of Cetuximab Combined With Cisplatin or Carboplatin/Pemetrexed as First Line Treatment in Patients With Malignant Pleural Mesothelioma.
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.
Study Overview
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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-
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Antwerpen, Belgium
- UZ Antwerpen
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Ghent, Belgium, 9000
- University Hospital Ghent
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Mechelen, Belgium, 2800
- AZ St. Maarten
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Heerlen, Netherlands
- AMC Heerlen
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Cetuximab (Erbitux)
|
Patients will be treated with standard chemotherapy (4-6 cycles), combined with weekly administration of Cetuximab (Erbitux) until disease progression.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Progression fee survival rate
Time Frame: At 18 weeks
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At 18 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Response rate according to modified RECIST criteria
Time Frame: every 6 weeks until progression
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every 6 weeks until progression
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Toxicity (CTCAE version 4)
Time Frame: weekly during treatment and follow-up of AE's until 30 days after last dosis
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weekly during treatment and follow-up of AE's until 30 days after last dosis
|
Overall survival
Time Frame: average survival of 9 - 12 months
|
average survival of 9 - 12 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Veerle Surmont, MD, University Hospital, Ghent
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Lung Neoplasms
- Adenoma
- Neoplasms, Mesothelial
- Pleural Neoplasms
- Mesothelioma
- Mesothelioma, Malignant
- Antineoplastic Agents
- Antineoplastic Agents, Immunological
- Cetuximab
Other Study ID Numbers
- 2009/337
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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