A prospective randomized trial of Bleomycin vs Doxycycline vs Talc for intrapleural treatment of malignant pleural effusion

Originating Group

Participating Groups

Objectives

1. To compare intrapleural bleomycin, doxycycline, and talc in the treatment of malignant pleural effusions with respect to: a) time to recurrence of the effusion, b) necessity forfurther treatment of recurrent effusions, c) extent of post-instillation complications, including pain severity and dyspnea, d) duration of chest tube or soft catheter drainage required following pleurodesis, e) duration of hospitalization for retreatment of MPE at time of recurrence, and f) survival.

Eligibility

1. Cytologically confirmed malignant pleural effusion or an exudative effusion with a positive pleural biopsy from any tumor type.
2. Drainage of the affected pleural space by tube thoracostomy (chest tube > 24F) or soft catheter with: a) re-expansion of the lung demonstrated by CXR, b)continuing drainage less than 250/24hrs, or equivalent measured over at least 4 hours if chest tube employed.
3. ECOG performance status 0,1, or 2.
4. No prior intrapleural therapy or change in systemic therapy for the previous 2 weeks priorto on study (patients may be started on systemic chemo- or hormonotherapy following pleurodesis)
5. No significant prior irradiation to the affected hemithorax (painful bone lesions may be irradiated on the affected side but the field must not include a significant portion of the pleura.
6. No prior systemic bleomycin.
7. No bilateral effusions requiring treatment, chylous effusion, thoracoscopic lysis of adhesions on the side being treated, or prior instillation of sclerosing agents on the side being treated.

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