Treatment of malignant mesothelioma with pemetrexed (Alimta) + platinum (4 courses) or pemetrexed (Alimta) + platinum (4 courses) followed by Caelyx single drug (4 courses).

INTERVENTION: Trade Name: ALIMTA Pharmaceutical Form: Powder for solution for infusion Trade Name: Caelyx Pharmaceutical Form: Solution for infusion Product Name: cisplatin Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: cisplatin Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 1‐ Product Name: Carboplatin Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Carboplatin Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 10‐ CONDITION: Malignant pleural mesotelioma ; MedDRA version: 9.1 Level: LLT Classification code 10027407 Term: Mesothelioma malignant PRIMARY OUTCOME: Main Objective: To compare time to progression (TTp) with the pre‐determined in the two treatment arms (Alimta + platinum drug or Alimta + platinum drug followed by Caelyx single drug). Primary end point(s): Time to progression (TTP); Duration of response; Duration of overall survival Secondary Objective: Toxicity; Response; Duration of response; Time to tumour response; Quality of Life; Overall survival INCLUSION CRITERIA: Patients may be included in the study only if they meet ALL of the following criteria: 1. Histologically (or cytologically if later confirmed by a mesothelioma panel) proven diagnosis of mesothelioma of the pleura, with subtyping (epitheloid, mixed, sarcomatous or not classifiable). Not a candidate for potentially curative surgery (see Appendix). All stages. 2. At least one unidimensionally measurable lesion(s) of the pleura with clearly defined margins by computerized tomography (CT) with a thickness of ³1 cm OR for example measurable lymph node(s) (or both). The CT scan should not be older than 28 days before start of treatment. 3. Patients may have undergone pleurodesis. If so, a minimum delay of 28 days must follow before study drugs are administered. If the original CT scan was performed prior to the pleurodesis, a new CT scan is required 28 or more days after the pleurodesis, which will then be considered the baseline scan. 4