Clinical trial: Surgery and Intrapleural Docetaxel in Treating Patients With Malignant Pleural Effusion (NCT00114205)

Eligibility criteria:
DISEASE CHARACTERISTICS:

          -  Histologically or cytologically confirmed malignant pleural effusion (MPE)

               -  Symptomatic disease

          -  Candidate for thoracoscopic surgery for treatment of MPE

               -  No known or suspected ipsilateral pleurodesis that would preclude surgery

          -  No bilateral MPEs

          -  No progressive extrapleural disease that is untreatable and/or resistant to systemic
             treatment

        PATIENT CHARACTERISTICS:

        Age

          -  18 and over

        Performance status

          -  ECOG 0-2

        Life expectancy

          -  Not specified

        Hematopoietic

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

          -  Platelet count ≥ 100,000/mm^3

          -  Hemoglobin ≥ 8.0 g/dL

        Hepatic

          -  ALT and/or AST ≤ 1.5 times upper limit of normal (ULN) (if alkaline phosphatase
             normal) OR

          -  Alkaline phosphatase ≤ 2.5 times ULN (if ALT and/or AST normal)

          -  Bilirubin normal

          -  INR ≤ 1.5

        Renal

          -  Creatinine ≤ 1.8 mg/dL

        Other

          -  Not pregnant

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception during and for ≥ 1 month after
             completion of study treatment

          -  No history of severe hypersensitivity reaction to docetaxel or other drugs formulated
             with polysorbate 80

          -  No peripheral neuropathy > grade 1

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  Not specified

        Chemotherapy

          -  No concurrent systemic chemotherapy

        Endocrine therapy

          -  Not specified

        Radiotherapy

          -  Not specified

        Surgery

          -  Not specified
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