Switch maintenance treatment with gemcitabine for patients with malignant mesothelioma who do not progress after 1st line therapy with a pemetrexed-platinum combination. A randomised open label phase II study. ;NVALT 19

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 124

Inclusion Criteria

• Patients with histologically or cytologically proven malignant mesothelioma •
Age >= 18 years. • At the date of randomisation, the patients must have
completed 4 cycles of first-line chemotherapy with a platinum (cisplatin or
carboplatin) and pemetrexed combination at least 21 days but no more than 42
days prior to study entry, and have no evidence of progressive disease
following first-line treatment. • Measurable or evaluable disease, according to
modified RECIST criteria for pleural mesothelioma. • Ability to understand the
study and give signed informed consent prior to beginning of protocol specific
procedures. • WHO performance status <= 2 • Adequate organ function as evidenced
by the following peripheral blood counts or serum chemistries at study entry: -
Hematology: Neutrophil count >= 1.5 x 109/l, Platelets >= 100 x 109/l, Hemoglobin
>= 6.2 mmol/l. - Hepatic function as defined by serum bilirubin <= 1.25 times the
upper limit of normal (ULN), ALT and AST <= 2.5 times the ULN, except if liver
metastases then ALAT and ASAT < 5 times the ULN. - Renal function as defined by
serum creatinine <= 1.25 times ULN or creatinine clearance >= 50 ml/min (by
Cockcroft-Gault formula).

Exclusion Criteria

• Active uncontrolled infection or severe cardiac dysfunction (such as New York
Heart Association Class III or IV cardiac disease, myocardial infarction within
the last 6 months, unstable arrhythmias, or unstable angina).
• Presence of symptomatic CNS metastases.
• Radiotherapy within 2 weeks prior to study entry.
• Unstable peptic ulcer, unstable diabetes mellitus or other serious disabling
condition.
• Concomitant administration of any other experimental drugs under
investigation.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint is progression free survival, defined as time from<br /><br>randomisation to disease progression or death (in case no progression has been<br /><br>documented)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Adverse events<br /><br>- Objective radiological response rate in patients with measurable disease<br /><br>- Overall survival<br /><br>- Changes in vital capacity and FEV1.<br /><br><br /><br>Exploratory endpoints include:<br /><br>- biomarker analysis<br /><br>- germline polymorphisms of relevant candidate genes<br /><br>- new techniques to analyse standard imaging data</p><br>

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