Clinical trial: Bleomycin, Doxycycline, or Talc in Treating Patients With Malignant Pleural Effusions (NCT00002872)

Eligibility criteria:
DISEASE CHARACTERISTICS: Cytologically confirmed unilateral malignant pleural effusion or
        exudative effusion with positive biopsy from any tumor type No chylous effusion Drainage of
        effusion with chest tube or soft catheter required Lung re-expansion demonstrated on chest
        x-ray Continuing drainage less than 250 mL/24 hours (or equivalent measured over 4 hours)

        PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Hematopoietic:
        (within 2 weeks prior to entry) WBC greater than 2,000 Platelets greater than 50,000
        Hepatic: Not specified Renal: (within 2 weeks prior to entry) Creatinine less than 2.5
        mg/dL OR Creatinine clearance greater than 40 mL/min Other: No pregnant or nursing women
        Adequate contraception required of fertile patients

        PRIOR CONCURRENT THERAPY: No prior sclerosing agents on the affected side No prior
        intrapleural therapy No change in systemic therapy for at least 2 weeks prior to
        randomization Biologic therapy: Not specified Chemotherapy: No prior systemic bleomycin
        Systemic chemotherapy allowed after pleurodesis Endocrine therapy: Hormone therapy allowed
        after pleurodesis Radiotherapy: No significant radiotherapy to affected hemithorax
        Irradiation of painful bone lesions allowed on the affected side if field does not include
        a significant portion of the pleura Surgery: See Disease Characteristics No prior
        thoracoscopic lysis of adhesions on the affected side
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