A PROSPECTIVE RANDOMIZED TRIAL OF BLEOMYCIN VS. DOXYCYCLINE VS. TALC FOR THE INTRAPLEURAL TREATMENT OF MALIGNANT PLEURAL EFFUSIONS
OBJECTIVES: I. Compare intrapleural bleomycin vs. doxycycline vs. talc in the treatment of
malignant pleural effusion with respect to time to recurrence of the effusion. II. Compare
these treatments with respect to the necessity for further treatment of recurrent effusions.
III. Compare these treatments with respect to the extent of postinfusion complications,
including pain and dyspnea. IV. Compare these treatments with respect to duration of chest
tube or soft catheter drainage required following pleurodesis. V. Compare these treatments
with respect to duration of hospitalization for retreatment of malignant pleural effusion
following recurrence. VI. Compare these treatments with respect to survival. VII. Compare
these treatments with respect to the impact of the procedure on pain and dyspnea.
OUTLINE: This is a randomized trial. Patients are stratified by type of drainage device and
participating institution. All patients are randomized to undergo pleurodesis with
bleomycin, doxycycline, or talc by indwelling pleural catheter. A second procedure is
undertaken 72 hours later if pleural drainage is persistently large. Patients are followed
monthly for survival.
PROJECTED ACCRUAL: A total of 480 patients will be entered over 48 months.
Allocation: Randomized, Primary Purpose: Supportive Care
John C. Ruckdeschel, MD
H. Lee Moffitt Cancer Center and Research Institute
United States: Federal Government