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Phase II Study of Cetuximab Combined With Cisplatin or Carboplatin/Pemetrexed as First Line Treatment in Patients With Malignant Pleural Mesothelioma.


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Cancer

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Trial Information

Phase II Study of Cetuximab Combined With Cisplatin or Carboplatin/Pemetrexed as First Line Treatment in Patients With Malignant Pleural Mesothelioma.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression fee survival rate

Outcome Time Frame:

At 18 weeks

Safety Issue:

No

Principal Investigator

Veerle Surmont, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospital, Ghent

Authority:

Belgium: Federal Agency for Medicinal Products and Health Products

Study ID:

2009/337

NCT ID:

NCT00996567

Start Date:

October 2009

Completion Date:

September 2013

Related Keywords:

  • Cancer
  • Malignant mesothelioma
  • Mesothelioma

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