pleural mesothelioma
Conditions
Interventions
need or use for any other
anti-cancer agent other than protocol treatment, except for palliative
radiotherapy.
Treatment with Gemcitabine or best supportive care.
Gemcitabine will be given intravenously at day 1 and day 8 of a 3-weeks cycle
at a dose of 1250 mg/m2. Study treatment will continue until disease
unacceptable grade 3 or 4 treatment toxicity
serious intercurrent
illness
patient request for discontinuation
Sponsors
Stichting NVALT studies
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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 = 1.5 x 109/l, Platelets >= 100 x 109/l, Hemoglobin >= 6.2 mmol/l. - Hepatic function as defined by serum bilirubin = 50 ml/min (by Cockcroft-Gault formula).
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is progression free survival, defined as time from randomisation to disease progression or death (in case no progression has been documented) | — |
Secondary
| Measure | Time frame |
|---|---|
| - Adverse events - Objective radiological response rate in patients with measurable disease - Overall survival - Changes in vital capacity and FEV1. Exploratory endpoints include: - biomarker analysis - germline polymorphisms of relevant candidate genes - new techniques to analyse standard imaging data | — |
Countries
Netherlands
Outcome results
None listed