Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:33 AM
Ignite Modification Date:
2025-12-25 @ 12:33 AM
NCT ID:
NCT00996567
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00996567
Study Brief:
Protocol Section:
NCT00996567