By adding Cetuximab to standard treatment, we hope to prolonge progression free survival
ID
Source
Brief title
Condition
- Mesotheliomas
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Progression fee survival rate at 18 weeks
Secondary outcome
- Response rate according to modified RECIST criteria
- Toxicity (CTCAE version 4)
- Overall survival
Background summary
Multicenter , open phase 2 study on 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).
The translation research program consists of the determination of EGFR- and
K-Ras mutations on the tumor tissue and the correlation with outcome.
Study objective
By adding Cetuximab to standard treatment, we hope to prolonge progression free
survival
Study design
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.
Intervention
A. Physical examination: weekly during in maintenace and every 3 months during
follow up
B. Pulmonary function test: baseline and 18 weeks after initiating therapy
C. CT scan thorax and upper abdomen: every 6 weeks during maintenance
D. Blood sampling: weekly during maintenace treatment with cetuximab
Study burden and risks
Burden and risks consist of the adverse events associated: most common are
rash, allergic reactions and lung problems. Other, less frequent are fatigue,
dyspnea, headache, vomiting and mucositis (mouth for example).
Henri Dunantstraat 5
6401CX Heerlen
NL
Henri Dunantstraat 5
6401CX Heerlen
NL
Listed location countries
Age
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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| Other | 2009/337 |
| EudraCT | EUCTR2009-014293-17-NL |
| CCMO | NL32991.096.10 |