Pemetrexed Disodium and Cisplatin Followed By Surgery and Radiation Therapy in Treating Patients With Malignant Pleural Mesothelioma
Malignant Mesothelioma
About this trial
This is an interventional treatment trial for Malignant Mesothelioma focused on measuring epithelial mesothelioma, sarcomatous mesothelioma, localized malignant mesothelioma, recurrent malignant mesothelioma
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])
Sites / Locations
- Universitair Ziekenhuis Antwerpen
- Istituto Nazionale per la Ricerca sul Cancro
- Azienda Ospedaliera Di Parma
- Universita Degli Studi di Udine
- Sint Antonius Ziekenhuis
- Daniel Den Hoed Cancer Center at Erasmus Medical Center
- Princess Royal Hospital at Hull and East Yorkshire NHS Trust
- Edinburgh Cancer Centre at Western General Hospital