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: Authorised-recruitment may be ongoing or finished

Sex: All

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).

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 62
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 62

Exclusion Criteria

• Active uncontrolled infection, severe cardiac dysfunction or uncorrectable bleeding tendency.
• 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 clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Determine the potential improvement of the duration of progression-free survival by maintenance treatment with gemcitabine;Secondary Objective: 1. To compare the objective radiological response (ORR) rate<br>2. To compare overall survival (OS)<br>3. To assess and compare the lung function<br>4. To describe the toxicity<br>5. To identify potential biomarkers<br><br>;Primary end point(s): The primary endpoint is progression free survival, defined as time from randomisation to disease progression or death (in case no progression has been documented);Timepoint(s) of evaluation of this end point: every 6 weeks

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - Adverse events<br>- Objective radiological response rate in patients with measurable disease<br>- Overall survival<br>- Changes in vital capacity and FEV1. <br><br>;Timepoint(s) of evaluation of this end point: every 6 weeks until off-study, thereafter every 12 weeks until dead

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