A PROSPECTIVE RANDOMIZED TRIAL OF BLEOMYCIN VS. DOXYCYCLINE VS. TALC FOR THE INTRAPLEURAL TREATMENT OF MALIGNANT PLEURAL EFFUSIONS


Phase 3
18 Years
N/A
Not Enrolling
Both
Metastatic Cancer

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Trial Information

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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Supportive Care

Principal Investigator

John C. Ruckdeschel, MD

Investigator Role:

Study Chair

Investigator Affiliation:

H. Lee Moffitt Cancer Center and Research Institute

Authority:

United States: Federal Government

Study ID:

CDR0000065154

NCT ID:

NCT00002872

Start Date:

November 1996

Completion Date:

Related Keywords:

  • Metastatic Cancer
  • malignant pleural effusion
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary
  • Pleural Effusion
  • Pleural Effusion, Malignant

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