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

Primary Purpose

Metastatic Cancer

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
bleomycin sulfate
doxycycline
talc
Sponsored by
Eastern Cooperative Oncology Group
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Metastatic Cancer focused on measuring malignant pleural effusion

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    November 1, 1999
    Last Updated
    June 21, 2023
    Sponsor
    Eastern Cooperative Oncology Group
    Collaborators
    National Cancer Institute (NCI), North Central Cancer Treatment Group
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00002872
    Brief Title
    Bleomycin, Doxycycline, or Talc in Treating Patients With Malignant Pleural Effusions
    Official Title
    A PROSPECTIVE RANDOMIZED TRIAL OF BLEOMYCIN VS. DOXYCYCLINE VS. TALC FOR THE INTRAPLEURAL TREATMENT OF MALIGNANT PLEURAL EFFUSIONS
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Completed
    Study Start Date
    January 10, 1997 (Actual)
    Primary Completion Date
    February 2003 (Actual)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Eastern Cooperative Oncology Group
    Collaborators
    National Cancer Institute (NCI), North Central Cancer Treatment Group

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Metastatic Cancer
    Keywords
    malignant pleural effusion

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Phase 3
    Allocation
    Randomized
    Enrollment
    480 (Anticipated)

    8. Arms, Groups, and Interventions

    Intervention Type
    Biological
    Intervention Name(s)
    bleomycin sulfate
    Intervention Type
    Drug
    Intervention Name(s)
    doxycycline
    Intervention Type
    Other
    Intervention Name(s)
    talc

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    120 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    John C. Ruckdeschel, MD
    Organizational Affiliation
    H. Lee Moffitt Cancer Center and Research Institute
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Randolph S. Marks, MD
    Organizational Affiliation
    Mayo Clinic
    Official's Role
    Study Chair

    12. IPD Sharing Statement

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