Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Supportive care, Treatment	Completed	18 and over	NCI	E-8592 NCCTG-942853, NCI-P96-0076, NCT00002872

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.

Entry 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)

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

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

Expected Enrollment

A total of 480 patients will be entered over 48 months.

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.

Trial Contact Information

Trial Lead Organizations

Eastern Cooperative Oncology Group

John Ruckdeschel, MD, Protocol chair(Contact information may not be current)		Ph: 813-979-7265; 888-663-3488 Email: ruckdeschel@moffitt.usf.edu

North Central Cancer Treatment Group

Randolph Marks, MD, Protocol chair		Ph: 507-284-2511

Registry Information
Official Title		A PROSPECTIVE RANDOMIZED TRIAL OF BLEOMYCIN VS. DOXYCYCLINE VS. TALC FOR THE INTRAPLEURAL TREATMENT OF MALIGNANT PLEURAL EFFUSIONS
Trial Start Date		1996-11-06
Registered in ClinicalTrials.gov		NCT00002872
Date Submitted to PDQ		1996-11-06
Information Last Verified		2009-01-30

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