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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00002872
Recruitment Status : Completed
First Posted : September 2, 2004
Last Update Posted : August 29, 2013
National Cancer Institute (NCI)
North Central Cancer Treatment Group
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Metastatic Cancer Biological: bleomycin sulfate Drug: doxycycline Other: talc Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 480 participants
Allocation: Randomized
Primary Purpose: Supportive Care
Study Start Date : November 1996
Actual Primary Completion Date : February 2003

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00002872

Sponsors and Collaborators
Eastern Cooperative Oncology Group
National Cancer Institute (NCI)
North Central Cancer Treatment Group
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Study Chair: John C. Ruckdeschel, MD H. Lee Moffitt Cancer Center and Research Institute
Study Chair: Randolph S. Marks, MD Mayo Clinic

Layout table for additonal information Identifier: NCT00002872     History of Changes
Other Study ID Numbers: CDR0000065154
First Posted: September 2, 2004    Key Record Dates
Last Update Posted: August 29, 2013
Last Verified: August 2013
Keywords provided by Eastern Cooperative Oncology Group:
malignant pleural effusion
Additional relevant MeSH terms:
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Pleural Effusion, Malignant
Pleural Effusion
Pleural Diseases
Respiratory Tract Diseases
Pleural Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Anti-Bacterial Agents
Anti-Infective Agents
Antiprotozoal Agents
Antiparasitic Agents
Antibiotics, Antineoplastic
Antineoplastic Agents