Clinical trial NCT00227630 (phase 2, status: completed)
Conditions: malignant mesothelioma
ICD codes: C45.9, C45.0, C45.1, C45.2, C45.7
Drugs: cisplatin, pemetrexed disodium
SMILES: [H][C@@]12N(C)C3=CC(OC)=C(C=C3[C@@]11CCN3CC=C[C@](CC)([C@@]13[H])[C@@]([H])(OC(C)=O)[C@]2(O)C(=O)OC)[C@]1(C[C@@]2([H])CN(CC(CC)=C2)CC2=C1NC1=CC=CC=C21)C(=O)OC, [H][C@@](CCC(O)=O)(NC(=O)C1=CC=C(CCC2=CNC3=C2C(O)=NC(=N)N3)C=C1)C(O)=O
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed malignant pleural mesothelioma

               -  All subtypes allowed

          -  T1-3, N0-1, M0 disease

               -  No N2 or N3 involvement confirmed by mediastinoscopy within 21 days before study
                  entry

          -  No clinical invasion of mediastinal structures (e.g., heart, aorta, spine, esophagus)

          -  No wide-spread chest wall invasion except focal chest wall lesions

          -  No clinical or radiological evidence of shrinking hemithorax

          -  No clinically significant third-space fluid (e.g., pleural effusions or ascites) that
             cannot be managed with thoracentesis or pleurodesis

        PATIENT CHARACTERISTICS:

        Age

          -  Under 70

        Performance status

          -  WHO 0-1

        Life expectancy

          -  Not specified

        Hematopoietic

          -  WBC > 3,500/mm^3

          -  Absolute neutrophil count > 1,500/mm^3

          -  Platelet count > 100,000/mm^3

          -  Hemoglobin ≥ 11 g/dL

        Hepatic

          -  AST and ALT < 1.5 times upper limit of normal (ULN)

          -  Bilirubin < 1.5 times ULN

          -  Alkaline phosphatase < 1.5 times ULN

        Renal

          -  Creatinine clearance ≥ 60 mL/min

          -  Acceptable (predicted) post-radiotherapy renal function by semiquantitative isotope
             renography, with a relative contribution of the contralateral kidney of ≥ 40%

        Pulmonary

          -  See Disease Characteristics

        Other

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception during and for 3 months after
             completion of study treatment

          -  Deemed to be fit enough to undergo study treatment

          -  No preexisting sensory neurotoxicity > grade 1

          -  No uncontrolled infection

          -  No prior or concurrent melanoma, breast cancer, or hypernephroma

          -  No other malignancy within the past 5 years except carcinoma in situ of the cervix or
             adequately treated basal cell skin cancer

          -  No psychological, familial, sociological, or geographical condition that would
             preclude study compliance

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  No concurrent immunotherapy

          -  No concurrent routine use of colony-stimulating factors during neoadjuvant
             chemotherapy

               -  Concurrent secondary prophylactic use allowed during neoadjuvant chemotherapy

          -  No concurrent secondary prophylactic use of colony-stimulating factors during
             post-operative radiotherapy

        Chemotherapy

          -  No prior chemotherapy for mesothelioma

        Endocrine therapy

          -  No concurrent hormonal cancer therapy

        Radiotherapy

          -  No prior radiotherapy to the lower neck, thorax, or upper abdomen

        Surgery

          -  See Disease Characteristics

        Other

          -  No other concurrent anticancer therapy

          -  No other concurrent experimental medications

          -  No nonsteroidal anti-inflammatory drugs or salicylates for 2 days before, during, and
             2 days after administration of neoadjuvant chemotherapy (5 days before and 2 days
             after for drugs with a long half-life [e.g., naproxen, piroxicam, diflunisal, or
             nabumetone])