Clinical trial: Cisplatin With or Without Pemetrexed Disodium in Treating Patients With Malignant Mesothelioma of the Pleura That Cannot be Removed by Surgery (NCT00005636)

Eligibility criteria:
DISEASE CHARACTERISTICS: Histologically confirmed malignant mesothelioma of the pleura not
        amenable to curative surgery Must be radiologically accessible Unidimensionally or
        bidimensionally measurable disease Pleural effusions or positive bone scan not considered
        measurable No brain metastases

        PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life
        expectancy: At least 12 weeks Hematopoietic: Absolute neutrophil count at least 1,500/mm3
        Platelet count at least 100,000/mm3 Hemoglobin at least 9 g/dL Hepatic: Bilirubin no
        greater than 1.5 times upper limit of normal (ULN) Alkaline phosphatase, AST, and ALT no
        greater than 3.0 times ULN (no greater than 5 times ULN with liver involvement) Albumin at
        least 3.0 g/dL Renal: Creatinine clearance at least 45 mL/min Other: No serious systemic
        disorders that may preclude study No prior primary malignancy within the past 5 years
        except carcinoma in situ of the cervix or adequately treated basal cell carcinoma of the
        skin No obvious malnourishment or greater than 10% weight loss within 6 weeks prior to
        study No active infection Not pregnant or nursing Fertile patients must use effective
        contraception during and for 3 months after study

        PRIOR CONCURRENT THERAPY: Biologic therapy: Prior immunomodulators allowed for pleurodesis
        No concurrent immunotherapy Chemotherapy: No prior systemic chemotherapy At least 1 week
        since prior bleomycin for pleurodesis Prior intracavitary cytotoxic drugs allowed for
        pleurodesis No other concurrent chemotherapy Endocrine therapy: No concurrent hormonal
        anticancer therapy Radiotherapy: At least 4 weeks since prior radiotherapy to target lesion
        Lesion must be clearly progressive No concurrent radiotherapy Surgery: See Disease
        Characteristics No concurrent surgery for cancer Other: At least 4 weeks since any other
        prior investigational agent No concurrent aspirin or other nonsteroidal antiinflammatory
        drug from 2 days prior to 2 days after study (5 days prior for long acting agents such as
        piroxicam, naproxen, diflunisal, or nabumetone) No other concurrent experimental
        medications
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.


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