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

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 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.

Tracking Information
First Received DateOctober 15, 2009
Last Changed DateFebruary 7, 2017
Start DateOctober 2009
Actual Primary Completion DateSeptember 2015
Primary Outcome Measures

Progression fee survival rate [Time Frame: At 18 weeks]

Secondary Outcome Measures

Response rate according to modified RECIST criteria [Time Frame: every 6 weeks until progression]

Toxicity (CTCAE version 4) [Time Frame: 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]

Descriptive Information
PhasePhase 2
Study TypeInterventional
Condition
  • Cancer
Intervention
  • Drug: Cetuximab (Erbitux)
Study Arms / Comparison Groups1 / 0
Recruitment Information
Recruitment StatusCompleted
Actual Enrollment22
GenderAll
Ages18 Years - N/A
Accepts Healthy VolunteersNo
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

Administrative Information
NCTIDNCT00996567
Responsible Party,
SponsorUniversity Hospital, Ghent
Verification DateFebruary 2017
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