Clinical trial: Pemetrexed Disodium and Cisplatin Followed By Surgery and Radiation Therapy in Treating Patients With Malignant Pleural Mesothelioma (NCT00227630)

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])
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.

Subject must be at most 69 Years

Patient description (medical language): A 61-year-old man comes to the clinic due to nonproductive cough and progressive dyspnea.  The patient's medical conditions include hypertension, hypercholesteremia and peptic ulcer disease.  He smokes 2 packs of cigarettes daily for the past 30 years.  On examination, there are decreased breath sounds and percussive dullness at the base of the left lung.  Other vital signs are normal. Abdomen is soft without tenderness. CT scan shows a left-sided pleural effusion and nodular thickening of the pleura. The plural fluid was bloody on thoracentesis. Biopsy shows proliferation of epithelioid-type cells with very long microvilli.

Patient description (patient's own words): I am 61 and I had to go to the clinic because I couldn't stop coughing and I experienced some breath shortness. I suffer from hypertension and cholesterol and I also have a stomach ulcer. I should admit that I've been smoking 2 packs of cigarettes every day for the past 30 years. My doctor told me that my breath in my left lung sounds bad. But he told me that my blood pressure, heart rate, breathing rate and temperature are normal. My belly is also normal. However my X-Rays show some liquid on the left side and a mass where the liquid got hard. The scary thing is that the liquid was bloody when they got it out. They did a biopsy and it showed that I have an increase of epithelioid-type cells with very long microvilli.

Does the patient match the trial criteria? Entailment