Status:
COMPLETED
A Study of Cetuximab Combined With Cisplatin or Carboplatin/Pemetrexed as First Line Treatment in Patients With Malignant Pleural Mesothelioma.
Lead Sponsor:
University Hospital, Ghent
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 treat...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2015
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT00996567
Start Date
October 1 2009
End Date
September 1 2015
Last Update
February 9 2017
Active Locations (4)
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1
UZ Antwerpen
Antwerp, Belgium
2
University Hospital Ghent
Ghent, Belgium, 9000
3
AZ St. Maarten
Mechelen, Belgium, 2800
4
AMC Heerlen
Heerlen, Netherlands