Bleomycin, Doxycycline, or Talc in Treating Patients With Malignant Pleural Effusions

Phase 3

Completed

• Conditions: Metastatic Cancer

• Registration Number: NCT00002872
• Lead Sponsor: Eastern Cooperative Oncology Group

Brief Summary

RATIONALE: Some drugs such as bleomycin or doxycycline, or other compounds like talc, may help to control fluid in the chest caused by cancer. It is not yet known if bleomycin, doxycycline, or talc is more effective in treating patients with malignant pleural effusions.

PURPOSE: Randomized phase III trial to compare the effectiveness of bleomycin, doxycycline, or talc in treating patients with malignant pleural effusions.

Detailed Description

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.

Study Timeline

• Study Start: 1997-01-10
• Study First Submitted: 1999-11-01
• Primary Completion: 2003-02
• Study First Submitted QC: 2004-09-01
• Study First Posted: 2004-09-02
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-21
• Last Update Posted: 2023-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 480

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified